Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 04:5

CTRI Number CTRI/2013/11/004133 [Registered on: 07/11/2013] - Trial Registered Prospective

Last Modified On 17/11/2018
Post Graduate Thesis No
Type of Trial Interventional
Type of Study Drug
Study Design Randomized, Parallel Group, Active Controlled Trial
Public Title of Study A Randomized, Double?blind, Double?dummy, Active?controlled, Multi?centre Trial
(respiratory and urinary infections) Caused by ? – Lactamase (ESBL and MBL) prod
Negative Bacteria

Scientific Title of A Randomized, Double?blind, Double?dummy, Active?controlled, Multi?centre Trial

Study Efficacy and Safety of CSE?1034 (Ceftriaxone+ Sulbactam+ EDTA) with Meropene
Caused by ? – Lactamase (ESBL and MBL) producing Gram Negative Bacteria

Secondary IDs if Any Secondary ID

VRL/CSE-1034/05/2012;ver1.0;5/Jun/12 and ver
1.1; 8/May/14

Details of Principal
Investigator or overall Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Scientific Name
Query)
Designation
Affiliation
 Address

Phone
Fax
Email

Details Contact
Person (Public Query) Name
Designation

Affiliation
Address

Phone
Fax
Email

Source of Monetary or
Material Support > Venus Remedies Limited Hill Top Industrial Estate Near Jharmajri, E.P.I.P., Phas
Village Bhatoli Kalan Baddi, Himachal Pradesh Pin code: 173 205, India

Primary Sponsor
Name
Address

Type of Sponsor

Details of Secondary Name

Sponsor NIL
Countries of List of Countries
Recruitment India
 Sites of Study Name of Principal Name of Site
Investigator
Dr Deepak Dewan Ajanta Hospital &
research Centre

Dr Prem Nath Dogra All india Institute of

Medical Sciencies

Dr Kim Jacob Mammen CMC Hospital

Dr Pratibha Phadke Deenanath Mangeshkar

Hospital and Research
Centre

Dr Rajeev Sood Dr. Ram Manohar Lohia

Hospital & PGIMER

New Delhi – 110001,

India, Room No. 31,
New Delhi
DELHI
Dr Mahendra Z Patel Government Medical Government Medical
College, College, New Civil
Hospital, Outside
Majuragate,
Surat-395001, Gujarat,
India
Surat
GUJARAT
Dr Milind Vyawahare Government Medical Department of
College, Nagpur Medicine, Government
Medical College,
Medical Chowke,
Nagpur-4400003,
Maharashtra, India
Nagpur
MAHARASHTRA

Dr Sarat Kumar Behera Hi-Tech Medical Hi-Tech Medical

College & Hospital College & Hospital,
Pandra, Rasulgarh,Bhu
baneswar-751010,
Odisha, India
Nayagarh
ORISSA

Dr Madhav Prabhu J.L.N Medical College & KLE Dr. Prabhakar

KLEs Dr. Prabakar Kore Hospital &
Kore Hospital Research Centre,
Nehru Nagar, Balagavi,
Karnataka
Belgaum
KARNATAKA

Dr Mohd Shamim J.L.N. Medical College, Associate Professor

Aligarh Department of
Tuberculosis and chest
diseases, J.L.N.
Medical College,
Aligarh Muslim
university, Aligarh (U.P)
202002
Aligarh
UTTAR PRADESH

Dr Huliraj N KIMS Hospital, KIMS Hospital,

Banglore KIMS
Hospital, Banglore
Professor & HOD,
Department of
Pulmonology Medicine,
KIMS Hospital &
Research Center,
K.R.Road, V.V.Puram,
Bangalore KA, 560004
Bangalore
KARNATAKA

Dr Rahul Janak Sinha King Georges Medical King Georges Medical

University University Lucknow,
Uttar Pradesh, India-
 226003
Lucknow
UTTAR PRADESH
Dr Dharam Raj Maurya M V Hospital & 314/30, Mirza Mandi,
research Centre Chowk, Lucknow -
226003, UP, India
Lucknow
UTTAR PRADESH

Dr Sishir Gang Muljibhai Patel Muljibhai Patel

Urological Hospital Urological Hospital
(Kidney Hospital) (Kidney Hospital),Dr.
Virendra Desai Road,
Nadiad 387001, Gujarat
(India)
Kheda
GUJARAT

DrShalini Srivastava Om Surgical Center & Om Surgical Center &

Maternity Home Maternity Home
SA-17/3, P-4, Sri
Krishna Nagar,
Paharia,Ghazipur
Road, Varanasi
-221007
Varanasi
UTTAR PRADESH

DrNeeraj Gupta Paras Hospital C-1, Shushant Lok-1

Sector -92 Gurgaon,
Haryana -122002
Gurgaon
HARYANA

Dr Ajoy K Sarkar Peerless Hospitax Peerless Hospitax

Hospital And Research Hospital And Research
Center Limited Center Limited
360,Panchasayar,
Kolkata.
Kolkata
WEST BENGAL

Dr Ravi Mohan Postgraduate Institute Department of Urology

Mavuduru of Medical education & Postgraduate Institute
Research, Chandigarh of Medical Education &
Research, Sector-12,
Chandigarh,Pin- 160
012, India
Chandigarh
CHANDIGARH

Dr Nagaraju Boyilla Prime Hospital Prime Hospital,

MIG-113 & 114, Road
No-1, KPHB Colony,
Kukatpally,
Hyderabad-500072
Hyderabad
ANDHRA PRADESH
Dr Rahul Kapoor Ratandeep Hospital Ratandeep Hospital
and Research Centre, and Research Centre,
1-6, Besides Rave Moti,
Kakadeo, Kanpur –
208025 , India
Kanpur Nagar
UTTAR PRADESH

Dr RP Agrawal S.P. Medical College,

Bikaner-

Dr Desai Janak Samved Hospital,

Dinkarrai

Dr Manjunath M Sapthagiri Institute of

Medical Sciences and
Research Centre,

Dr Parvaiz A Koul Sher-I-Kashmir Institute

of Medical Sciences

Dr Sudhir Chadha Sir Ganga Ram

Hospital
 Dr Narendra Khippal SMS Medical College &
Hospital

Dr Ashish Kumar Deb Sudbhawana Hospital

Dr Ram Murti Singh Trimurti Hospital

Details of Ethics Name of Committee Approval Status

Committee
Institutional Ethics Approved
Comittee Ratandeep
Hospital & Research
Centre

Institutional Ethics Approved 15/10/2013

Commitee Sapthagiri
Institute of Medical
Sciences & Research
Centre

IEC, Deenanath Approved 18/10/2013

Mangeshkar Hospital &
Research Centre
Ethics Committee S.P Approved 20/11/2013
Medical College & A G
Hospitals
Ethics Approved 31/10/2013
CommitteeSamved
Hospital
Institutional Ethics Approved 01/11/2013
Comittee Christian
Medical College &
Hospital

Ethics Committee SMS Approved 31/12/2013

Medical College
Muljibhai Patel Society Approved 27/12/2013
for Research in
Nephrology Ethics
Committee

Ethics Committee Approved 25/01/2014

Hitech Hospital
Ethics Committee Approved 04/01/2014
Peerless Hospital
Ethics Committee Approved 12/12/2013
Prime Hospital
Ethics Committee KIMS Approved 13/11/2013
Institutional Ethics Approved 17/12/2013
Committee, Dept of
Pharmacology, Govt.
Medical College,
Nagpur

Institutional Ethics Approved 22/02/2015

Committee MV Hospital
& Research Centre
Institutional Ethics Approved 29/03/2015
Committee Ajanta
Hospital & IVF Centre
Sudbhawna Hospital Approved 28/02/2015
Ethics Committee
Institutional Ethics Approved 04/01/2016
Committee, Om
Surgical Centre &
Maternity Homes

Hospital Ethics Approved 31/12/2015

Commitee
Institutional Ethics Approved 18/02/2016
Committee King
Georges Medical
University

Ethics Committee, Approved 05/04/2016

KLEs University
 Institute Ethics Approved
Committee, AIIMS
IEC, Sher-i-Kasmir Approved
Institute of Medical
Sciences
Institutional Ethics Approved
Committe, PGI
IEC, AMU Approved
Institutional Ethics Approved
committee, PGIMER,
Dr. RML Hospital, New
Delhi

Ethics committee, Sir Approved

Ganga Ram Hospital
Human Research Approved
Ethics Committee,
GMC, Surat
Trimurti Hospital Ethics Approved
Committee, Varanasi

Regulatory Clearance Status

Status from DCGI Approved/Obtained

Health Condition / Health Type

Problems Studied Patients

Patients

Intervention / Type
Comparator Agent Intervention

Comparator Agent

Inclusion Criteria
Age From
Age To
Gender
 Details

Exclusion Criteria
 Details

Method of Generating Stratified block randomization

Random Sequence
Method of Centralized
Concealment
Blinding/Masking Double Blind Double Dummy
Primary Outcome Outcome
The FDA co-primary endpoints: Proportion of
patients with symptomatic resolution (or return to
premorbid state) of all UTI-specific symptoms in
the mMITT analysis set AND Proportion of
patients with both a per-patient microbiological
 eradication and symptomatic resolution (or return
to premorbid state) of all UTI-specific symptoms
in the mMITT analysis set
EMA primary endpoint: Proportion of patients
with a favorable per-patient microbiological
response in the mMITT analysis set

Secondary Outcome Outcome

•Proportion of patients with favorable clinical
response assessment and, separately, favorable
per-patient microbiological response in patients
infected with a Meropenem-resistant pathogen
•Time to first defervescence in patients who
have fever at study entry
•Number of deaths with more than 5 days of
treatment till TOC visit
•Total duration of treatment
•Change in Subject Quality of life using
MOS–SF–36 scale
•Pharmacoeconomic data of CSE–1034 versus
the comparator

• Proportion of patients with a favorable

per-patient microbiological response,
symptomatic resolution (or return to premorbid
state) of all UTI-specific symptoms, favorable
per-pathogen microbiological response in all
analysis sets respectively.

Target Sample Size Total Sample Size=348

Sample Size from India=348
Final Enrollment numbers achieved (Total)=230
Final Enrollment numbers achieved (India)=230

Phase of Trial Phase 3

Date of First 30/12/2013
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=2
Trial Months=0
Days=0

Recruitment Status of Not Applicable

Trial (Global)
Recruitment Status of Completed
Trial (India)
Publication Details No publication
Brief Summary Protocol Title: A Randomized, Double?blind, Double?dummy, Active?controlled, Mu
to Compare the Efficacy and Safety of CSE?1034 (Ceftriaxone + Sulbactam + EDTA
Meropenem in Infections Caused by ? – Lactamase (ESBL and MBL) producing Gra
Bacteria.
Primary Objective: To evaluate the efficacy of CSE?1034 compared to meropenem
suffering from pneumonia (moderate to severe community acquired pneumonia, hos
pneumonia and health care associated pneumonia) and complicated urinary tract in
by ? – lactamase producing gram?negative bacteria.
Secondary Objective:
• To evaluate the occurrence of relapse
• To evaluate the occurrence of superinfection
• To evaluate the efficacy of CSE?1034 in ESBL/MBL producing gram negative bac
infection.
• Evaluation of Pharmacoeconomic analysis in the clinical efficacy evaluable (CEE)
 Protocol Title: A Randomized, Double?blind, Double?dummy, Active?controlled, Mu
to Compare the Efficacy and Safety of CSE?1034 (Ceftriaxone + Sulbactam + EDTA
Meropenem in Infections Caused by ? – Lactamase (ESBL and MBL) producing Gra
Bacteria.
Primary Objective: To evaluate the efficacy of CSE?1034 compared to meropenem
suffering from pneumonia (moderate to severe community acquired pneumonia, hos
pneumonia and health care associated pneumonia) and complicated urinary tract in
by ? – lactamase producing gram?negative bacteria.
Secondary Objective:
• To evaluate the occurrence of relapse
• To evaluate the occurrence of superinfection
• To evaluate the efficacy of CSE?1034 in ESBL/MBL producing gram negative bac
infection.
• Evaluation of Pharmacoeconomic analysis in the clinical efficacy evaluable (CEE)

successfully treated patients.

Safety Objectives:
Safety and tolerability will be assessed by recording incidence of adverse event
adverse events, lab parameters which includes hematology, clinical bioche
examinations, ECG during the study period.
Primary Endpoints: Primary efficacy endpoints of this study have been presen
satisfy varying regulatory guidelines of FDA and EMA. The FDA co-primary
as:
• Proportion of patients with symptomatic resolution (or return to premorbid sta
UTI-specific symptoms (frequency/urgency/ flank pain / suprapubic pain) at th
mMITT analysis set
• Proportion of patients with both a per-patient microbiological eradication a
resolution (or return to premorbid state) of all UTI-specific symptoms (frequ
/ suprapubic pain) at the TOC visit in the mMITT analysis set
EMA primary endpoint is defined as:
• Proportion of patients with a favorable per-patient microbiological resp
the mMITT analysis set.
Secondary Endpoints:
• Proportion of patients with a favorable per-patient microbiological respo
and LFU visits in the mMITT, ME, and extended ME analysis sets
• Proportion of patients with symptomatic resolution (or return to premorbid sta
UTI-specific symptoms (frequency/urgency/ flank pain / suprapubic pain) at
visits in the mMITT, ME, extended ME, and CE analysis set
• Proportion of favorable per-pathogen microbiological response at the
in the mMITT, ME, and extended ME analysis sets
• Proportion of patients with an investigator-determined clinical cure at t
visits in the mMITT, ME, extended ME, and CE analysis sets
• Proportion of patients with favorable investigator clinical response ass
favorable per-patient microbiological response at the TOC visit for patients infect
Meropenem-resistant pathogen in the extended ME analysis sets
• Proportion of patients with symptomatic resolution (as defined in the co-
TOC for patients infected with a Meropenem-resistant pathogen in the extend
• Time to first defervescence while on IV study therapy in patients in the
ME, and CE analysis sets who have fever at study entry
• Number of deaths due to cUTI with more than 5 days of treatment till TOC visit.
• Total duration of treatment in the ME, and CE analysis sets.
• To measure the difference change in Subject Quality of life using MOS–SF–3
• Pharmacoeconomic data of CSE–1034 versus the comparator will be an
medications; hospitalization charges; cost of interventions done for source con
X–ray, cultures, interventions, lab investigations, etc.).
Safety End Points:
• Proportion of patients with any treatment?emergent adverse event (TEAE)
• Proportion with any TEAE resulting in discontinuation of study drug therapy
• Proportion with serious adverse events (SAEs) during study drug therapy
Criteria for evaluation of clinical assessment
Clinical cure: All or most pre-therapy signs and symptoms of the index infect
resolved such that no additional antibiotics are required
Clinical failure: Patients who meet any one of the criteria below will be considere
• Death related to targeted infection
• No apparent response to treatment; persistence or progression of mo
and symptoms or use of additional antibiotics for the current infection
• Patient previously met criteria for failure (not applicable for the EOT visit)
Indeterminate:
Study data are not available for evaluation of efficacy for any reason, including:
• Patient lost to follow-up or assessment not undertaken such that a determ
response cannot be made at either the EOT, TOC, or LFU visit
• Death where targeted infection is clearly noncontributory
• Circumstances that preclude classification as a cure or failure
Criteria for evaluation of microbiological assessment
Eradication: A specimen culture taken within 48 hours prior to randomizati
culture from the EOT visit or compared with the culture from the TOC or LFU

culture obtained at the relevant visit demonstrates <104 CFU/mL of the orig
patient was not bacteremic (if the patient was bacteremic at Screening, the bacte
resolved)
Indeterminate: Study data are not available for evaluation of efficacy, for any r
• Patient is lost to follow-up or an assessment is not undertaken such tha
obtained (or culture results could not be interpreted for any reason) at eithe
the LFU visit
• Death where targeted infection is clearly noncontributory
• Circumstances that preclude classification as an eradication or persistence
Failure:
Persistence:
• A pathogen present at Screening grew at ?104 CFU/mL at EOT or TOC
• Death related to targeted infection
Superinfection: A urine culture grew ?105 CFU/mL of a pathogen other than
during the course of active treatment with study therapy along with worsen
of infection or the emergence during treatment with study therapy of a new pathogen
 New infection: A pathogen other than an original pathogen found at Screenin
CFU/mL any time after treatment has finished. If any pathogen was isolated f
the primary infection after treatment with study therapy had been completed, th
designated as a new infection.
STUDY ANALYSIS SET
Microbiological modified intent-to-treat analysis set
The mMITT analysis set includes all patients who: ?
• Had clinical evidence of a targeted infecion and a positive study entry
?105 CFU/mL of a Gram-negative pathogen susceptible to both the drugs.
• Had no more than 2 microorganisms identified in the study entry culture
count. Any patient with a Gram-positive pathogen, or a bacterial species typ
respond to both study drugs will be excluded.
Microbiologically evaluable analysis sets at the EOT and TOC visits
The ME analysis set at the EOT and TOC visits include all patients meeting t
• Were included in the mMITT analysis set
• Either Received therapy for ?48 hours, with ?80% of the scheduled dr
number of days administered or Received therapy <48 hours before discon
an AE
• Had no important protocol deviations that would affect the assessment of effica
• Had a microbiological assessment at the EOT or TOC visits, respecti
response other than indeterminate, including a quantitative urine culture
• Did not receive any antibiotic therapy with potential activity against the ba
collected at Screening between the time of the baseline culture and the EOT or
respectively (other than protocol defined study therapy). Study therapy is defin
study drug. This does not include antibiotic therapy taken for the treatment
patients who were considered failures
• Had a study entry urine culture obtained ?48 hours before the start of t
therapy
• Had 1 or at most 2 baseline pathogens susceptible to both IV study therapies
Microbiologically evaluable analysis set at the LFU visit
The ME analysis set at the LFU visit includes all patients meeting the following crite
• Were included in the ME analysis set at the TOC visit
• Had a microbiological assessment at the LFU visit, with a microbiologi
indeterminate, including an interpretable quantitative urine culture
• Had no confounding events since the TOC visit, defined as any events t
assessment of the microbiologic responses. An example of confounding even
study procedures
• Did not receive any antibiotic therapy with potential activity against the
the TOC visit. This does not include antibiotic therapy taken for the treatmen
by patients who were considered failures
Extended microbiological evaluable analysis set
The extended ME analysis set at the EOT, TOC, and LFU visits includes patien
criteria for the ME analysis set, with the exception that baseline pathogens
to either study therapy.
Clinically evaluable analysis set at the EOT and TOC visits
 The CE analysis set at the EOT and TOC visits includes all patients meeting
• Were included in the mMITT analysis set
• Either Received therapy for ?48 hours, with ?80% of the scheduled dr
number of days administered or Received therapy <48 hours before discon
an AE
• Had no important protocol deviations that would affect the assessment of effica
• Had a clinical outcome assessment of clinical cure or failure (and not
or TOC visits, respectively
• Did not receive antibiotic therapy with potential activity against the bas
the time of the baseline culture and the EOT or TOC culture, respectively (other than
protocol-defined study therapy). Study therapy is defined as blinded IV study
include antibiotic therapy taken for the treatment of targeted infection by patients
considered failures.
• Had the study entry urine culture obtained ?48 hours before the start o
therapy
Clinically evaluable analysis set at the LFU visit
The CE analysis set at the LFU visit includes all patients meeting the following criter
• Were included in the CE analysis set at the TOC visit
• Had a clinical outcome assessment of clinical cure or failure (and not in
the LFU visit
• Had no important protocol deviations that would affect the assessment of effica
• Did not receive any antibiotic therapy with potential activity against the
the TOC visit. This does not include antibiotic therapy taken for the treatmen
by patients who were considered failures.
Safety Analysis Set
All randomized patients will be considered in safety analysis set.
Determination of sample size
Assuming both treatments had an underlying true response of > 96% for ea
and that mMITT analysis set included 60% of randomized patients, a sampl
was required. For each primary endpoint, non-inferiority of CSE-1034 versus M
considered demonstrated if the lower limit of the 2-sided 95%confidence interva
treatment difference was greater than 15% (sponsor) or greater than 10% (FDA a
The sample size across the combined study database ensured >85% power for a 10
non-inferiority margin and >98% power for 15% non-inferiority margin. The sp
non-inferiority if the lower limit of the 95% CI (corresponding to a 97.5% 1-sid
greater than –15% for co-primary outcome variables; however, non-inferiority
using a 10% margin in regions where this is a regulatory requirement. A se
be performed for the co-primary outcome variables for both the EOT and TOC v
separately for the components of the second co-primary variable, i.e., per pa
eradication and symptomatic resolution (or return to premorbid state) of all
(frequency/urgency/dysuria/suprapubic pain/flank pain) at TOC as part of the
variables assessment in the mMITT analysis set. The analysis for the co-pr
and, as part of the secondary efficacy variable assessment, their components (a
previously) will be performed and presented by subgroups. The subgroups to b
include, but not be limited to, type of infection, baseline pathogens, age, and s
historical trials has indicated that a 15% margin is appropriate for assessme
cUTI trials; however, there are regional variations in the regulatory requirem
trials. To meet these requirements globally, this trial has been sized to provid
10% non-inferiority margin, required in some regions (therefore providing >98
non-inferiority using a 15% margin).
 Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 04:5

CTRI Number CTRI/2013/02/003340 [Registered on: 01/02/2013] - Trial Registered Prospective

Last Modified On 05/03/2014
Post Graduate Thesis No
Type of Trial Interventional
Type of Study Drug
Study Design Randomized, Parallel Group, Active Controlled Trial
Public Title of Study Cefozopran injection in treatment of complicated urinary tract infection and pyelonep
Scientific Title of Comparative Efficacy, Safety and Tolerability of Inj. Cefozopran Hydrochloride and
Study Sulphate in the Treatment of Complicated Urinary Tract Infections and Pyelonephrit
Open-label Study.

Secondary IDs if Any Secondary ID

R2011004 - Version 2 dated 25.10.2012

Details of Principal
Investigator or overall Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Scientific Name
 Name
Query)
Designation
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Public Query) Name
Designation
Affiliation
Address

Phone
Fax
Email

Source of Monetary or
Material Support > Ranbaxy Laboratories Ltd., Plot No. 77 B, Sector 18, IFFCO Road Gurgaon - 122
Primary Sponsor
Name
Address
Type of Sponsor

Details of Secondary Name

Sponsor NIL
Countries of List of Countries
Recruitment India
Sites of Study Name of Principal Name of Site
Investigator
Dr Suresh B Patankar ACE Hospital and
Research Centre AMAI
Charitable Trust

Dr Vinay Mahendra Apollo Gleneagles

Hospital

Dr Pratit Samdani Bhatia Hospital Medical

Research Society

Dr Arpita Department of
Roychowdhury Nephrology IPGME and
R SSKM Hospital

Dr Harvinder Singh Department of surgery

Pahwa KING GEORGES
MEDICAL
UNIVERSITY

Dr Sharadchandra Dr Sharadchandra
Prasad Prasad

Dr Suresh S Dubhashi Dr Suresh S Dubhashi

 Dr Alok Jain Fortis Escorts Hospital

Dr Apurva Parekh Medilink Hospital and

Research Center

Dr Ravinder R Sabnis Muljibhai Patel

Urological Hospital

Dr Sandeep Kumar MV Hospital and

Gupta Research Centre,
Lucknow

Dr Sandeep Deshmukh Orange City Hospital &

Research Institute

Dr Rakesh Kapoor Sanjay Gandhi Post

Graduate Instituite of
Medical Sciences,
Lucknow

Dr Shivam Priyadarshi SMS Medical College

and Hospital

Dr Vaddi Chandra St Theresa Hospital

Mohan

Details of Ethics Name of Committee Approval Status

Committee
ACE Hospital and AMAI Approved
Charitable Trust Ethics
Committee, Pune
Bhatia Hospital Medical Approved
Research Society
Ethics Committee
Ethics Committee St. Approved
Theresas Hospital,

Hyderabad
Institutional Ethics Approved
Commitee Bioethic Cell
SGPGIMS Lucknow
Institutional Ethics Approved
Committee Apollo
Gleneagles Hospitals
Kolkata

Institutional Ethics Approved

Committee Fortis
Escorts Hospital, Jaipur
Institutional Ethics Approved
Committee KGMU,
Lucknow
Institutional Ethics Approved
Committee SMS
Medical College and
Hospital, Jaipur

Institutional Ethics Approved

Committee Vintage
Hospital and Medical
research Centre Pvt Ltd
Caculo Enclave St Inez
Panaji Goa

Institutional Ethics Approved

Committee, MV
Hospital & Research
Centre Lucknow

Medilink Ethics Approved

Committee,
Ahmedabad
Muljibhai Patel Society Approved
for research in Nephro
Urology Ethical
Committee Nadiad
 Orange City Institutional Approved
Ethics Committee
Nagpur
Research Oversight Approved
Committee PIGMER
Kolkata
Supe Hospital Ethics Approved
Committee Opposite
Adhar Ashram Near
Rungta School
Gharpure Ghat Ashok
Stambh Nashik

Regulatory Clearance Status

Status from DCGI Approved/Obtained
Health Condition / Health Type
Problems Studied Patients

Intervention / Type
Comparator Agent Intervention
 Comparator Agent

Inclusion Criteria
Age From
Age To
Gender
Details
Exclusion Criteria
Details
 Method of Generating Computer generated randomization
Random Sequence
Method of Not Applicable
Concealment
Not Applicable
 Blinding/Masking Not Applicable
Primary Outcome Outcome
Microbiological Outcome

Secondary Outcome Outcome

Clinical Outcome

Target Sample Size Total Sample Size=100

Sample Size from India=100
Final Enrollment numbers achieved (Total)=
Final Enrollment numbers achieved (India)=

Phase of Trial Phase 3

Date of First 04/02/2013
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=0
Trial Months=9
Days=0

Recruitment Status of Not Applicable

Trial (Global)
Recruitment Status of Completed
Trial (India)
Publication Details Not Applicable
Brief Summary This is an open label, randomized, comparative study with an objectiv
the efficacy, safety and tolerability of Cefozopran inj. 1 gm against Ce
given twice daily for a period of minimum 7 days (may be given up to
treatment of complicated Urinary Tract Infection and Pyelonephritis. T
will be conducted at sites across all geographical locations of India. T
limit is 18 years. There is no upper age limit in the protocol approved
The primary objective of the study is to compare the efficacy of intrav
infusion of Cefozopran hydrochloride and Cefpirome sulphate in the t
complicated urinary tract infection and pyelonephritis with respect to
microbiological outcome at ‘Test of Cure’ Assessment (7+2 days post
The patients will be hospitalised for minimum of 7 days of for study dr
administration. After administration of at least 14 doses of Inj. Cefozopran o
Cefpirome, subjects may be switched to oral antibiotic treatment with Tab. Ci
Subjects eligible for oral antibiotic therapy will receive Tab. Ciprofloxacin (50
hourly) to complete the remaining days of the 10 day treatment period. The to
of study drug therapy (i.v. study drug only or i.v. study drug followed
ciprofloxacin) will be 10 days. However, depending upon the clinical c
the subject, the duration of treatment can be extended to 14 days at th
investigator’s discretion.
 This is an open label, randomized, comparative study with an objectiv
the efficacy, safety and tolerability of Cefozopran inj. 1 gm against Ce
given twice daily for a period of minimum 7 days (may be given up to
treatment of complicated Urinary Tract Infection and Pyelonephritis. T
will be conducted at sites across all geographical locations of India. T
limit is 18 years. There is no upper age limit in the protocol approved
The primary objective of the study is to compare the efficacy of intrav
infusion of Cefozopran hydrochloride and Cefpirome sulphate in the t
complicated urinary tract infection and pyelonephritis with respect to
microbiological outcome at ‘Test of Cure’ Assessment (7+2 days post
The patients will be hospitalised for minimum of 7 days of for study dr
administration. After administration of at least 14 doses of Inj. Cefozopran o
Cefpirome, subjects may be switched to oral antibiotic treatment with Tab. Ci
Subjects eligible for oral antibiotic therapy will receive Tab. Ciprofloxacin (50
hourly) to complete the remaining days of the 10 day treatment period. The to
of study drug therapy (i.v. study drug only or i.v. study drug followed
ciprofloxacin) will be 10 days. However, depending upon the clinical c
the subject, the duration of treatment can be extended to 14 days at th
investigator’s discretion.

Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 05:0

CTRI Number CTRI/2014/08/004926 [Registered on: 25/08/2014] - Trial Registered Retrospectiv

Last Modified On 22/11/2019
Post Graduate Thesis Yes
Type of Trial Interventional
Drug
Medical Device
 Type of Study Drug
Medical Device
Study Design Randomized, Parallel Group, Active Controlled Trial
Public Title of Study STUDY REGARDING PAIN RELIEF IN POSTOPERATIVE MINIMAL INVASIVE SU
KIDNEY REMOVAL FOR KIDNEY TRANSPLANTATION FOLLOWING INTRAPER
NEBULIZATION AND INTRAPERITONEAL INSTILLATION OF ROPIVACAINE

Scientific Title of INTRAPERITONEAL NEBULIZATION VERSUS INTRAPERITONEAL INSTILLATIO

Study ROPIVACAINE FOR POST-OPERATIVE PAIN MANAGEMENT FOLLOWING LAP
DONOR NEPHRECTOMY

Secondary IDs if Any Secondary ID

NIL

Details of Principal
Investigator or overall Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Scientific Name
Query)
Designation
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Public Query) Name
Designation
Affiliation
Address
 Phone
Fax
Email

Source of Monetary or
Material Support > SANJAY GANDHI POSTGRADUATE INSTITUTE OF MEDICAL SCIENCES,LUC
Primary Sponsor
Name
Address

Type of Sponsor

Details of Secondary Name

Sponsor NIL
Countries of List of Countries
Recruitment India

Sites of Study Name of Principal Name of Site

Investigator
Dr Rajeev Kumar SGPGIMS

Details of Ethics Name of Committee Approval Status

Committee
Institutional Ethics Approved
Committee

Regulatory Clearance Status

Status from DCGI Not Applicable
Health Condition / Health Type
Problems Studied Healthy Human Volunteers
Patients

Intervention / Type
Comparator Agent Comparator Agent
 Comparator Agent

Intervention

Inclusion Criteria
Age From

Age To
Gender
Details

Exclusion Criteria
Details

Method of Generating Computer generated randomization

Random Sequence
Method of Case Record Numbers
Concealment
Blinding/Masking Participant, Investigator and Outcome Assessor Blinded
Primary Outcome Outcome
 Postoperative pain

Secondary Outcome Outcome

Postoperative Fentanyl requirement

Hospital morbidity
Time of Unassisted walking

Hospital stay

Quality of life after surgery

Target Sample Size Total Sample Size=60

Sample Size from India=60
Final Enrollment numbers achieved (Total)=60
Final Enrollment numbers achieved (India)=60

Phase of Trial Post Marketing Surveillance

Date of First 20/12/2012
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=2
Trial Months=1
Days=0

Recruitment Status of Not Applicable

Trial (Global)
Recruitment Status of Completed
Trial (India)

Publication Details
Brief Summary Studies evaluating intraperitoneal local aesthetic instillation for pain relief after lapro
procedures have reported conflicting results. In this randomized,double blind study
effects of intraperitoneal local anesthetic nebulization for pain relief after laproscopic
nephrectomy.
METHODS; Patient undergoing elective laproscopic donor nephrectomy were rando
to receive either instillation of ropivacaine 0.5%,20 ml after induction of pneumoperi
nebulization of ropivacaine 1%, 3 ml before and after surgery. Anesthetic and surgic
were standardized. Degree of pain at rest and on deep breathing, incidence of shou
fentanyl consumption, unassisted walking time, and postoperative nausea and vom
evaluated at pacu, 6, 12, 24, 48 hours after surgery.
 Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 05:0

CTRI Number CTRI/2013/06/003761 [Registered on: 17/06/2013] - Trial Registered Retrospectiv

Last Modified On 18/08/2021
Post Graduate Thesis No
Type of Trial PMS
Type of Study Drug
Study Design Single Arm Study
Public Title of Study An observational and multicentric post marketing surveillance study to evaluate the
safety of Elores in patients with various bacterial infection
Scientific Title of An Observational, Multicentre, Prospective, Post Marketing Surveillance study to ev
Study and efficacy of ELORESTM (Ceftriaxone, Sulbactam and Disodium Edetate) in patie
bacterial infections (Labeled indications).

Secondary IDs if Any Secondary ID

NIL

Details of Principal
Investigator or overall Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Scientific Name
Query)
Designation
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Public Query) Name
 Name
Designation
Affiliation
Address

Phone
Fax
Email

Source of Monetary or
Material Support > Venus Remedies Limited Hill Top Industrial Estate Near Jharmajri, E.P.I.P., Phas
Village Bhatoli Kalan Baddi, Himachal Pradesh Pin code: 173 205, India

Primary Sponsor
Name
Address

Type of Sponsor

Details of Secondary Name

Sponsor NIL

Countries of List of Countries

Recruitment India
Sites of Study Name of Principal Name of Site
Investigator
Dr Sarat Kumar Behera AMRI Hospital
 Dr V Apollo Hospital
Ramasubramanian

Dr S S Arora Batra Hospital &

Medical Research
Centre

Dr Amit Bery Dayanand Medical

College & Hospital

Dr Prof Deepak Malviya Dr. Ram Manohar Lohia

Institute of Medical
Sciences

Dr Vivek Nangia Ethics Committe for Fortis Flt. Lt. Ranjan

Research Fortis Dhall Hospital, Sector
Hospital B, Pocket 1, Aruna Asaf
Ali Marg, Vasant Kunj,
New Delhi - 110070
New Delhi
DELHI

Dr C L Nawal Ethics Committee SMS SMS Medical College &

Medical College & Attached Hospital,
Attached Hospital Jaipur
Jaipur
RAJASTHAN

Dr Avi Kumar Fortis Escorts Heart Department of

Institute Pulmonology
New Delhi
DELHI
Dr Vishal Bhambri Fortis Hospital Sector - 62, Phase -
VIII, Mohali - 160062
Chandigarh
CHANDIGARH

Dr Randeep Guleria Institute Ethics ALL INDIA INSTITUTE

Committee All India OF MEDICAL
Institute of Medical SCIENCES Room No
Sciences 102, 1 st Floor Old O.
T. Block, ANSARI
NAGAR, NEW DELHI
110029
New Delhi
DELHI

Dr Tanu Singhal Kokilaben Dhirubhai Kokilaben Dhirubhai

Ambani Hospital & Ambani Hospital &
Medical Research Medical Research
Institute Institute, Rao saheb
Achutrao Patwardhan
Marg, Four bungalows,
Andheri west, Mumbai
400 053
Mumbai
MAHARASHTRA

Dr B K Agarwal M. M. Institute of Dean Academic

Medical Sciences and Department of Medicine
Research Mullana, Ambala,
Haryana, India
Pin-133203
Ambala
HARYANA

Dr Ranjana Chhabra Max Super speciality Max Super speciality

Hospital Hospital(A Unit of Balaji
Medical & Diagnostic
Research Centre),
108-A, Indraprastha
Ext., Patparganj, New
Delhi-110092
New Delhi
DELHI

Dr Yatin Mehta Medanta The Medicity Medanta- The Medicity,

Institute of Critical Care
and Anaesthesia Sector
- 38, Gurgaon Haryana
 Dr Ravimohan S Postgraduate Institute
Mavuduru of Medical Education &
Research

Dr Prachee Sathe Ruby Hall Clinic

Dr Parvaiz Koul Sher-i-Kashmir Institute

of Medical Sciences

Details of Ethics Name of Committee Approval Status

Committee
Institutional Ethics Approved
Committee Fortis
Hospital
Institutional Ethics Approved
Committee SMS
Medical College &
AttachedHospitals

Drug Trial Ethics Approved

Committee
Ethics Committee For Approved
Research Fortis
Hospital
Institutional Ethics Approved
Committee
Institutional Ethics Approved
Committee ALL INDIA
INSTITUTE OF
MEDICAL SCIENCES

Institutional Ethics Approved

committee Dr. Ram
Manohar Lohia Institute
of Medical Sciences

Institutional Ethics Approved

Committee M M
Institute of Medical
Sciences and Research
 Institutional Ethics Approved
Committee Poona
Medical Research
Foundation

Institutional Ethics Approved

Committee,
Bhubaneswar
Institutional Ethics Approved
Committee, FEHI
Institutional Ethics Approved
Committee-Clinical
Studies
Kokilaben Dhirubhai Approved
Ambani Hospital &
Medical Research
Institute

Max Superspeciality Approved

Hospital
Medanta the Medicity Approved
Scientific Research & Approved
Ethical Review
Committee

Regulatory Clearance Status

Status from DCGI Not Applicable
Health Condition / Health Type
Problems Studied Patients
Patients

Patients

Patients
Patients
Patients

Intervention / Type
Comparator Agent Intervention
Comparator Agent

Inclusion Criteria
Age From
 Age To
Gender
Details

Exclusion Criteria
Details

Method of Generating Not Applicable

Random Sequence
Method of Not Applicable
Concealment
Blinding/Masking Open Label
Primary Outcome Outcome
To obtain safety information on the use of
ELORESTM in patients with various bacterial
infections

Secondary Outcome Outcome

To monitor the therapeutic outcome of
ELORESTM (Ceftriaxone + Sulbactam +
Disodium Edetate) in subjects with various
bacterial infections (Labeled indications).

Target Sample Size Total Sample Size=2500

Sample Size from India=2500
Final Enrollment numbers achieved (Total)=Applicable only for Completed/Termi
Final Enrollment numbers achieved (India)=Applicable only for Completed/Termi

Phase of Trial Post Marketing Surveillance

Date of First 03/07/2013
Enrollment (India)
Date of First No Date Specified
 No Date Specified
Enrollment (Global)
Estimated Duration of Years=0
Trial Months=6
Days=0

Recruitment Status of Not Applicable

Trial (Global)
Recruitment Status of Open to Recruitment
Trial (India)
Publication Details
TM

Study Title : - An Observational, Multicenter, Prospective, Post Marketing Surveillance study (P.M.S) to evaluate safety and efficacy of ELORES (Ceftriaxone+ Sulbactam+ Disodium Edetate) in patients with various bacterial infections (Labeled indications)

Brief Summary
TM

Primary Objective : - To obtain safety information on the use of ELORES (Ceftriaxone + Sulbactam + Disodium Edetate) in patients with various bacterial infections (Labeled indications).
TM

Secondary Objective : - To monitor the therapeutic outcome of ELORES (Ceftriaxone + Sulbactam + Disodium Edetate) in subjects with various bacterial infections (Labeled indications).
Primary Endpoints: Incidence of adverse events (AEs) and incidence of discontinuation due to AEs
Secondary Endpoints: Observe of Clinical Cure rate at the end of treatment
Study Design : - An observational multicenter, prospective, post marketing surveillance study
Study Duration : - 06 months (or as per sponsor’s discretion)

Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 05:0

CTRI Number CTRI/2013/12/004230 [Registered on: 20/12/2013] - Trial Registered Prospective

Last Modified On 25/07/2014
Post Graduate Thesis No
Type of Trial BA/BE
Type of Study
 Study Design Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study This study is a multi-centric, double blind 3 treatment parallel group bioequivalence
Pentosan Polysulfate Sodium, oral capsule 100 mg to Elmiron oral capsule 100 mg
treatments to placebo in the treatment of interstitial cystitis/bladder pain syndrome

Scientific Title of A MULTICENTRIC, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GRO

Study BIOEQUIVALENCE STUDY COMPARING PENTOSAN POLYSULFATE SODIUM,
CAPSULE 100 mg (WATSON PHARMA PVT. LTD.), TO ELMIRON ORAL CAPSUL
(ORTHO?MCNEIL?JANSSEN PHARMACEUTICALS, INC) AND BOTH ACTIVE TR
TO PLACEBO (WATSON PHARMA PVT. LTD.) IN THE TREATMENT OF INTERS
CYSTITIS / BLADDER PAIN SYNDROME

Secondary IDs if Any Secondary ID

ACTA/PSN/2013 (Version 1.0 dated 25th Feb
2013)

Details of Principal
Investigator or overall Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Scientific Name
Query)
Designation
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Public Query) Name
Designation
 Affiliation
Address

Phone
Fax
Email

Source of Monetary or
Material Support > Watson Pharma Pvt. Ltd., Unit II Plot No. K-7, MIDC Additional Ambernath Anand
Ambernath (East) Dist. Thane, Pin– 421 506, India. Tel. No. +91 (0) 251 6949700 F
251 3084800

Primary Sponsor
Name
Address

Type of Sponsor

Details of Secondary Name

Sponsor Nil
Countries of List of Countries
Recruitment India
Sites of Study Name of Principal Name of Site
Investigator
Dr Rajendra Kashinath Inamdar Multispeciality
Shimpi Hospital
 Dr Rajgopal V Apollo Hospitals

Dr Kiran Jadhav B.J. Govt. Medical

College and Sassoon
General Hospital

Dr Nagendranath Care Institute of Care Institute of

Mishra Medical sciences Medical sciences
(CIMS) (CIMS), Urology
Department, Ground
Floor, Near Shukan
mall, off science city
road, sola,
Ahmedabad-380060
Gujarat
Ahmadabad
GUJARAT

Dr Kim Mammen Christian Medical Christian Medical

College College, Department of
Urology, First Floor,
Christian Medical
College Brown
Road,CMC Campus,
Ludhiana-141008
Punjab
Ludhiana
PUNJAB
Dr Dinesh Jain Dayanand Medical Dept of Medicine, Office
College No - 2, Second Floor,
Dayanand Medical
College, D.M.C.
Road,Tagore Nagar,
Ludhiana- 141001
Ludhiana
PUNJAB

Dr Alok Jain Fortis Escorts Hospital Fortis Escorts Hospital,

Ground Floor, Jawahar
Lal Nehru Marg,
Malviya Nagar Jaipur,
RAJASTHAN
Jaipur
RAJASTHAN

Dr Shashank Desai GCS Medical College, GCS Medical College,

Hospital & Research Hospital & Research
Centre Centre, Ground Floor,
Roon No 9, Dept Of
Sugery, Naroda Rd, D
Colony,
Ahmedabad-380025
Gujarat
Ahmadabad
GUJARAT

Dr Muthu Veeramani Global Hospital Global Hospital, Kidney

Institute, First Floor,
Global Health city,
Medavakkam to
sholinganallur Rd,
Medavakkam, 439,
Cheran Nagar,
Perumbakkam,
Chennai - 600 100,
Tamil Nadu
Chennai
TAMIL NADU

Dr Arun Chawla Kasturba Hospital Kasturba Hospital

Manipal Manipal, Room no 14,

First Floor, Madhav
Nagar, Manipal -
576104, Karnataka
Dakshina Kannada
KARNATAKA
Dr Ch Subba Rao King George Hospital King George Hospital,
Department of Urology,
First Floor, Jagadamba
Area, KGH down road,
Maharani Peta
Visakhapatnam - AP
Visakhapatnam
ANDHRA PRADESH

Dr Ashish Pardeshi Medipoint Hospitals Medipoint Hospitals

Pvt.Ltd Pvt.Ltd, OPD Building,
3rd Floor, Research
Dept, 241/1, New D P
Road,Aundh, Pune-411
007
Pune
MAHARASHTRA

Dr Sunder Lal Tolani Monilek Hospital & Monilek Hospital &

Research Research, Dept of
Urology, Ground Floor,
Room No 2103,
Sector-4, Jawahar
Nagar, Jaipur -302004
Rajasthan
Jaipur
RAJASTHAN

Dr Ravindra Sabnis Muljibhai Patel Muljibhai Patel

Urological Hospital Urological Hospital, Uro
Office, Ground Floor,
Dr.V.V.Desai Rd,
Nadiad-387001 Kheda -
Gujarat
Kheda
GUJARAT

Dr SK singh Postgraduate Institute Postgraduate Institute

of Medical Education & of Medical Education &
Research Research, Nehru
Hospital, Department of
Urology, Second Floor,
B Block, Sector-12,
Chandigarh
Chandigarh
CHANDIGARH

Dr Shrenik Shah Rushabh Uro Hospital Rushabh Uro Hospital

2nd floor, Heritage
Plaza, Opp. Gurukul
Tower, Drive in Road,
Ahmedabad - 380052
Ahmadabad
GUJARAT

Dr Janak Desai Samved Urology Samved Urology

hospital hospital, Second Floor,
Near Stadium Circle,
Navrangpura,
Dr Sudhir Kanna Sir Ganga Ram
Hospital

Dr Sher Sing Yadav SMS Medical college &

hospital

Dr Raghunath Sri Venkateshwara

Sarakanuru Hospital

Dr Mohan Adhyam St. John’s Medical

College & Hospital
 Dr Sharadchandra Supe Heart & diabetes
Prasad Hospital & Research
centre

Details of Ethics Name of Committee Approval Status

Committee
Ethics Committee - Submittted/Under
Affiliated to Apollo Review

Hospitals Situated at
Apollo Hospitals (Apollo
Health City), Jubilee
Hills, Hyderabad,
Andhra Pradesh, India
Ethics Committee of Submittted/Under No Date Specified
care institute of Medical Review
Science - Affiliated to
CIMS hospital -
Ahmedabad - Gujarat

Ethics Committee Sir Submittted/Under No Date Specified

Ganga Ram Hospital - Review
Affiliated to Sir Ganga
Ram Hospital, New
delhi

Institutional Ethics Submittted/Under No Date Specified

Committee - Affilaited to Review
Global Hospitals and
Health City, 439,
Cheran Nagar,
Perumbakkam
Chennai-Tamilnadu
Institutional Ethics Submittted/Under No Date Specified
Committee - Affilaited to Review
Samved Hospital, 2nd
Floor, on Stadium circle
to Commerce College
Six Roads,
Navrangpura,
Ahmedabad, Gujarat

Institutional Ethics Submittted/Under No Date Specified

Committee - Affilated to Review
Medipoint Hospitals
Pvt.Ltd

Institutional Ethics Submittted/Under No Date Specified

Committee - Affiliated to Review
BJ Govt. Medical
College and Sassoon
Government Hospital,
Dept. of Pharmacology,
BJ Govt. Medical
College, Sassoon
Road, Pune - 411001

Institutional Ethics Submittted/Under No Date Specified

Committee - Affiliated to Review
CMC Ludhiana, Brown
Road, Punjab

Institutional Ethics Submittted/Under No Date Specified

Committee - Affiliated to Review
Dayanand Medical
College & Hospital,
Department of
Pharmacology Old
Campus, Civil Lines,
Ludhiana-141001,
Punjab

Institutional Ethics Approved 25/07/2013

Committee - Affiliated to
Fortis Escorts Hospital,

Jaipur, Rajasthan
 Institutional Ethics Submittted/Under No Date Specified
Committee - Affiliated to Review
GCS Medical college,
Hospital & Research
Centre, Opp. DRM
office, Nr. Chamunda
bridge, naroda Road,
Ahmedabad 25, Gujarat

Institutional Ethics Submittted/Under No Date Specified

Committee - Affiliated to Review
Inamdar Multispeciality
Hospital, Hospital
Building, S.No. 15,
Fatima Nagar,
Pune-411040,
Maharashtra

Institutional Ethics Submittted/Under No Date Specified

Committee - Affiliated to Review
Kasturba Hospital,
Manipal-Karnataka

Institutional Ethics Approved 30/05/2013

Committee - Affiliated to
Monilek Hospital &
Research Centre,
Jaipur, Rajasthan

Institutional Ethics Submittted/Under No Date Specified

Committee - Affiliated to Review
Muljibhai Patel society
for Research in
Nephro-Urology,
Jayaramdas Patel
Academic Centre,
Muljibhai Patel
Urological Hospital, Dr.
Virendra Desai Road,
Nadiad-387001, Gujarat

Institutional Ethics Submittted/Under No Date Specified

Committee - Affiliated to Review
Post Graduate Institute
of Medical Education &
Research
(PGIMER),Sector 12,
Chandigarh 160012
Punjab

Institutional Ethics Submittted/Under No Date Specified

Committee - Affiliated to Review
Supe Hospital, C/o
Supe heart & Diabetes
Hospital and Research
Centre, Opp.
Adharashram,
Gharpure Ghat, Near
Rungta High School,
Ashok Stambh,Nashik
422002, Maharshtra
Instiutional Ethics Submittted/Under No Date Specified
Committee King Review
George Hospital -

Affiliated to King
George Medical
College & Hospital Vish
akhapatnam-530002,
Andhra Pradesh
Rushab Uro Hospital Approved
Ethics Committee
(RUHEC) - Affiliated to
Rushab Uro Hospital -
Ahmedabad - Gujarat

Sri Venkateshwara Approved

Hospital Ethics
Committee - Affiliated to
Sri Venkateshwara
Hospital, Bangalore,
Karnataka

St John’s Medical Submittted/Under

College & Hospital Review
Institutional Ethics
Committee - Affiliated to
St. John’s Medical
College, Bangalore -
Karnataka

The Ethics Committee - Submittted/Under

Affiliated to S.M.S. Review
Medical College and
Attached Hospitals,
Jaipur First Floor,
Dhanvantri OPD Block,
S.M.S. Hospital, J.L.N.
Marg, Jaipur-Rajasthan

Regulatory Clearance Status

Status from DCGI Approved/Obtained
Health Condition / Health Type
Problems Studied Patients
Intervention / Type
Comparator Agent Intervention
 Intervention

Comparator Agent

Comparator Agent

Inclusion Criteria
Age From
Age To
Gender
 Details

Exclusion Criteria
Details
 Method of Generating Stratified randomization
Random Sequence
Method of Sequentially numbered, sealed, opaque envelopes
Concealment
Blinding/Masking Participant and Investigator Blinded
Primary Outcome Outcome
1. To evaluate the therapeutic equivalence of the
efficacy and safety of Pentosan Polysulfate
Sodium, Oral Capsule 100 mg (Watson Pharma
Pvt. Ltd) and Elmiron Oral Capsule 100 mg
(Ortho?McNeil?Janssen Pharmaceuticals, Inc) in
the treatment of interstitial cystitis/bladder pain
syndrome and

Secondary Outcome Outcome

1. To assess the superiority of the efficacy of
Pentosan Polysulfate Sodium, Oral

Target Sample Size Total Sample Size=528

Sample Size from India=528
Final Enrollment numbers achieved (Total)=Applicable only for Completed/Termi
Final Enrollment numbers achieved (India)=Applicable only for Completed/Termi

Phase of Trial N/A

10/01/2014
 Date of First 10/01/2014
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=2
Trial Months=0
Days=0

Recruitment Status of Not Applicable

Trial (Global)
Recruitment Status of Not Yet Recruiting
Trial (India)
Publication Details Not Applicable
Brief Summary

The proposed study is a Bioequivalence Study With Clinic

double blind, three-arm, parallel group, placebo
sites in India designed to establish bioequivalence of Pen
Capsule 100 mg (WATSON PHARMA PVT.
(Ortho ’McNeil ’Janssen Pharmaceuticals,
cystitis/bladder pain syndrome.

The objectives of this proposed trial are as below:

Ø To evaluate the therapeutic equivalence of the efficacy and

Sodium, Oral Capsule 100 mg (WATSON
Capsule 100 mg (Ortho ’McNeil ’Janssen
interstitial cystitis / bladder pain syndrome.

Ø To assess the superiority of the efficacy of Pentosan Poly

100 mg (WATSON PHARMA PVT. LTD.)
’McNeil ’Janssen Pharmaceuticals, Inc) in
pain syndrome.
 In this trial a total of 528 patients (176:176:176),
interstitial cystitis, need to be enrolled and randomized in
1:1:1 for Test vs. Ref vs. Placebo in order to achieve 42
PP population assuming that the overall dropout rate from
population is about 20%. Number of PPS non-naïve subje
exceed 264.

For this trial the patient participation will last for 91 days
treatment).

In this trial each patient will receive Investigational Medic

each orally three times daily as per randomization.
water at least 1 hour before meals or 2 hour after meals.
undergo visit wise assessment throughout the study for th
patient the primary endpoint evaluation will be assessed a
at visit no. 6, Day 90 ± 4 days).

A stratified randomization will be used for this study wher

divided into two sub-populations of PPS naïve & PPS non
be randomly assigned in a treatment allocation ratio of 1
or the Reference Product or the Placebo, respectively in e
assignment will be generated by a non-study

Medidata® solutions and will be generated by

Medidata Solutions, Inc., USA. A sealed copy
retained at the study site and should be available to FDA investiga
inspection to allow for verification of the treatment assigned to each subject.

CLINICAL ENDPOINTS:

TEST OF THERAPEUTIC EQUIVALENCE:

For the primary efficacy parameter, i.e. the proportion
population identified as “treatment success” occurring
and evaluated from baseline to end of treatment
interval for the difference in success proportions (PT – PR) betwe
products should be contained within [+0.20, -0.20] in order to establish

TEST OF SUPERIORITY:

As a parameter for determining adequate study

should both be statistically superior to placebo
rate occurring after 3 months of treatment (at the visit no. 6, Day
modified intent-to-treat (mITT) study population, with and without l
forward (LOCF).

Thus, each active arm will be compared to the

superiority of active arms over the placebo for the treatment succ
treatment visit. The tests for superiority will be
reference treatments and superiority will be claimed if the two-sid
5% level of significance for both, test and reference products separately.

A secondary subgroup analysis of the difference

outcome variable between PPS naïve vs PPS
non-naïve subjects enrolled in study should not exceed 264.

Comparison of the number of patients needing add-on/rescue the

mean times to add-on/rescue therapy in each
superiority of the active arms over placebo.
 Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 05:0

CTRI Number CTRI/2013/07/003805 [Registered on: 10/07/2013] - Trial Registered Retrospectiv

Last Modified On 25/06/2013
Post Graduate Thesis Yes
Type of Trial Interventional
Type of Study Drug
Study Design Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study A clinical study of the effects of the three licensed drugs alfuzosin, tamsulosin and s
patients with benign prostatic hyperplasia, a disease predominantly causing urinary
aging men.

Scientific Title of A comparative study of efficacy and tolerability of alfuzosin, tamsulosin and silodosi
Study prostatic hyperplasia.
Secondary IDs if Any Secondary ID
NIL

Details of Principal
Investigator or overall Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Scientific Name
Query)
Designation

Affiliation
Address

Phone
Fax
Email

Details Contact
 Person (Public Query) Name
Designation
Affiliation
Address

Phone
Fax
Email

Source of Monetary or
Material Support > Dr Manjunatha R

Primary Sponsor
Name
Address

Type of Sponsor

Details of Secondary Name

Sponsor NIL

Countries of List of Countries

Recruitment India
Sites of Study Name of Principal Name of Site
Investigator
Dr Manjunatha R Kempegowda Institute
of Medical Sciences
Hospital and Research
Centre

Details of Ethics Name of Committee Approval Status

Committee
Kempegowda Institute Approved
of Medical Sciences
 Regulatory Clearance Status
Status from DCGI Not Applicable
Health Condition / Health Type
Problems Studied Patients
Intervention / Type
Comparator Agent Intervention

Comparator Agent

Comparator Agent

Inclusion Criteria
Age From
Age To
Gender
Details

Exclusion Criteria
 Details

Method of Generating Random Number Table

Random Sequence
Method of Sequentially numbered, sealed, opaque envelopes
Concealment
Blinding/Masking Open Label
Primary Outcome Outcome
Change in total INTERNATIONAL PROSTATE
SYMPTOM SCORE (IPSS) from baseline.

Secondary Outcome Outcome

Change in peak urinary flow rate (Qmax) and
evaluation of subjective symptoms namely IPSS
voiding and storage scores and quality of life
(QOL) score compared to baseline.

Target Sample Size Total Sample Size=90

Sample Size from India=90
Final Enrollment numbers achieved (Total)=Applicable only for Completed/Termi
Final Enrollment numbers achieved (India)=Applicable only for Completed/Termi

Phase of Trial Post Marketing Surveillance

Date of First 06/06/2013
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=1
Trial Months=6
Days=0

Recruitment Status of Not Applicable

Trial (Global)
Recruitment Status of Open to Recruitment
Trial (India)
Publication Details None yet
Brief Summary This is a randomised, open label, parallel group study on comparative efficacy and
 tolerability of alfuzosin, tamsulosin and silodosin in patients with benign pr
that will be conducted at KIMS Hoapital and Research Centre, V V Puram
selected patients will be randomized into three groups of 30 in each, us
table, to receive alfuzosin SR 10 mg, tamsulosin
(immediately after meals) and tamsulosin (before meals) will be given on
silodosin (before breakfast) once daily in the morning. All
will be continued for 12 weeks. The primary endpoint for evalua
in total IPSS from baseline; secondary endpoints are change in Qmax (peak
of subjective symptoms namely IPSS voiding and storage scores and quality of life

During the study period the patients will be instructed not to crush, chew
and also not to drive or operate machinery, and to contact the doctor imm
any syncope, priapism or any other serious adverse event.
 Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 05:0

CTRI Number CTRI/2013/12/004239 [Registered on: 24/12/2013] - Trial Registered Prospective

Last Modified On 18/11/2019
Post Graduate Thesis No
Type of Trial Interventional
Type of Study Nutraceutical
Study Design Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study Evaluation of methi seeds extract in patients with kidney stones
Scientific Title of A double blind, placebo controlled study to evaluate the efficacy and safety of IBHB
Study management of urolithiasis
Secondary IDs if Any Secondary ID
Protocol version 1.0 dated 19th August 2013

Details of Principal
Investigator or overall Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Scientific Name
Query)
Designation
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Public Query) Name
Designation
Affiliation
 Address

Phone
Fax
Email

Source of Monetary or
Material Support > Indus Biotech Pvt. Ltd., Pune

Primary Sponsor
Name
Address

Type of Sponsor

Details of Secondary Name

Sponsor NIL

Countries of List of Countries

Recruitment India
Sites of Study Name of Principal Name of Site
Investigator
Dr Siva Prasad Bhakti V
Gourabathini
Dr Pratit Samdani Bhatia

Dr Nilesh Rangnekar Brahma-Kumaris BSES

M G Hospital

Dr Rajendra Shimpi Inamdar Hospital

Dr Ravindra B Sabnis Muljibhai Patel

Urological Hospital
 Dr Shrenik Shah Rushabh Uro Hospital

Details of Ethics Name of Committee Approval Status

Committee
BhaktiVedanta Hospital Approved
Ethics Committee
BSES Municipal Approved
General Hospital Ethics
Committee, S.V Road,
Andheri (W),
Mumbai-400058

Clinical Trial Ethics Approved

Committee, G-1 Block,
Bhatia Hospital, Tardeo
Road, Mumbai -400007

Ethics Committee Approved

Inamdar Multispeciality
Hospital, Hospital
Building, S.NO.15,
Fatima Nagar,
Pune-411040,
Maharashtra, India

Muljibhai Patel Society Approved

for Research in
Nepro-urology
Rushabh Uro Hospital Approved
Ethics Committee

Regulatory Clearance Status

Status from DCGI Not Applicable
Health Condition / Health Type
Problems Studied Patients
Patients

Intervention / Type
Comparator Agent Intervention
 Comparator Agent

Inclusion Criteria
Age From
Age To
Gender
Details

Exclusion Criteria
Details

Computer generated randomization

 Method of Generating Computer generated randomization
Random Sequence
Method of Pre-numbered or coded identical Containers
Concealment

Blinding/Masking Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

Primary Outcome Outcome
Proportion of subjects with reduction in the size
of renal calculus/calculi as compared to baseline
between the groups

Secondary Outcome Outcome

1)Proportion of subjects with reduction in the
size and complete expulsion of renal calculus
2)Reduction in the diameter of largest renal
calculus, number and sum of diameters of renal
calculi 3)Change in the pH of urine and
estimated creatinine clearance 4)Change in pain
by VAS scores, number, amount of analgesics
consumed 4)QoL by KDQOL-SF™ 5)Safety in
terms of number of drop-out subjects, number of
patients with UTI, incidences of AEs, physical
examination, vital signs and lab parameters

Target Sample Size Total Sample Size=80

Sample Size from India=80
Final Enrollment numbers achieved (Total)=Applicable only for Completed/Termi
Final Enrollment numbers achieved (India)=Applicable only for Completed/Termi

Phase of Trial N/A

Date of First 03/02/2014
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=0
Trial Months=9
Days=0

Recruitment Status of Other (Terminated)

Trial (Global)
Recruitment Status of Other (Terminated)
Trial (India)
Publication Details Not published
Brief Summary Urolithiasis is a common and recurrent disease, impacting the quality of life of the a
individuals. IBHB is a standardized fenugreek extract showed excellent safety profil
studies. IBHB showed efficacy in animal model of kidney stone in terms of reduced
crystals and reversal of histological damage to interstitial areas of tubular epithelial
significant reduction in tubule interstitial damage index (TDI).
The present double blind, placebo controlled, randomized pilot study objective is aim
evaluation of efficacy and safety of IBHB (300 mg tablets twice daily) in patients with
12 weeks. A total of 100 patients will be randomized to receive test drug or placebo
The primary outcome measure of the study is proportion of subjects with reduction i
renal calculus/calculi. Secondary outcome measures are proportion of subjects with
size and complete expulsion of renal calculus, reduction in the diameter of largest re
 Urolithiasis is a common and recurrent disease, impacting the quality of life of the a
individuals. IBHB is a standardized fenugreek extract showed excellent safety profil
studies. IBHB showed efficacy in animal model of kidney stone in terms of reduced
crystals and reversal of histological damage to interstitial areas of tubular epithelial
significant reduction in tubule interstitial damage index (TDI).
The present double blind, placebo controlled, randomized pilot study objective is aim
evaluation of efficacy and safety of IBHB (300 mg tablets twice daily) in patients with
12 weeks. A total of 100 patients will be randomized to receive test drug or placebo
The primary outcome measure of the study is proportion of subjects with reduction i
renal calculus/calculi. Secondary outcome measures are proportion of subjects with
size and complete expulsion of renal calculus, reduction in the diameter of largest re
number and sum of diameters of renal calculi, change in the pH of urine and estima
clearance, change in pain by VAS scores, number, amount of analgesics consumed
KDQOL-SF™. Safety outcome measure include number of drop-out subjects, numb
with UTI, incidences of AEs, physical examination, vital signs and lab parameters.

Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 05:0

CTRI Number CTRI/2014/11/005174 [Registered on: 05/11/2014] - Trial Registered Retrospectiv

Last Modified On 03/11/2014
Post Graduate Thesis Yes
Type of Trial Interventional
Type of Study Surgical/Anesthesia
Study Design Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study The safety and efficacy of local anaesthetic injection in penis for diagnostic cystosco
Randomized controlled trial comparing three different techniques.
Scientific Title of The safety and efficacy of corpus spongiosum block as add on to topical anaesthes
Study cystoscopy - Randomized controlled trial comparing three different techniques.
Secondary IDs if Any Secondary ID
NIL

Details of Principal
Investigator or overall Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
 Address

Phone
Fax
Email

Details Contact
Person (Scientific Name
Query)
Designation
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Public Query) Name
Designation
Affiliation
Address

Phone
Fax

Email

Source of Monetary or
Material Support > JIPMER
Primary Sponsor
Name
 Address
Type of Sponsor

Details of Secondary Name

Sponsor NIL
Countries of List of Countries
Recruitment India

Sites of Study Name of Principal Name of Site

Investigator
Dr LN Dorairajan Department of urology ,
JIPMER

Details of Ethics Name of Committee Approval Status

Committee
JIPMER INSTITUTE Approved
ETHICS COMMITTEE

Regulatory Clearance Status

Status from DCGI Not Applicable
Health Condition / Health Type
Problems Studied Patients
Intervention / Type
Comparator Agent Intervention

Comparator Agent

Comparator Agent

Inclusion Criteria
Age From
Age To
Gender
Details
 Exclusion Criteria
Details

Method of Generating Computer generated randomization

Random Sequence
Method of Sequentially numbered, sealed, opaque envelopes
Concealment
Blinding/Masking Open Label
Primary Outcome Outcome
1. Degree of pain experienced during the
procedure using visual analog pain score (VAS)(
On 1 – 10 scale).

Secondary Outcome Outcome

2. Hemodynamically parameters such as – peak
systolic and diastolic blood pressure ; peak pulse
rate as surrogate markers for pain perception will
be recorded
3. Surgeons comfort and procedure time.

Target Sample Size Total Sample Size=60

Sample Size from India=60
Final Enrollment numbers achieved (Total)=Applicable only for Completed/Termi
Final Enrollment numbers achieved (India)=Applicable only for Completed/Termi

Phase of Trial Phase 3/ Phase 4

Date of First 01/06/2013
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=2
Trial Months=0
Days=0

Recruitment Status of Not Applicable

Trial (Global)
Recruitment Status of Open to Recruitment
 Open to Recruitment
Trial (India)
Publication Details
Brief Summary Cystourethroscopy for diagnosing bladder cancer either in a patient with a history of
the follow up of bladder cancer may be accomplished using either a rigid or a flexibl
Both of these instruments allow for thorough endoscopy of the urethra and the urina
also provide access to the upper urinary tract but have specific advantages and disa
may direct their use depending on the clinical situation. Rigid endoscopes have adv
improved image quality, a larger working channel and better visualization; they are e
manipulate and orient during endoscopy. But the procedure is perceived as being u
the patient, by some urologists, when performed under topical anesthesia as compa
cystoscopy. Advantages of the flexible cystourethroscope include improved patient
increased options for patient positioning and ease in passage over an elevated blad
median lobe. But the disadvantages include its shorter life, the greater cost of the eq
greater need for expertise. Recently intracorpus spongiosum block has been descri

urethrotomy in a few studies. This novel technique has been described as a sim
effective procedure that is comparable in efficacy to general or spinal anesthesia
non-randomized study. This is also an inexpensive procedure. In the presen
out if the technique of rigid cystoscopy with intracorpus spongiosum block as a
anesthesia is better than when performed under topical anesthesia and is
flexible cystoscopy under topical anesthesia, as it can then be more effective, sa
effective in Indian health set up on outpatient basis.
 Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 05:0

CTRI Number CTRI/2013/10/004111 [Registered on: 29/10/2013] - Trial Registered Retrospectiv

Last Modified On 29/10/2013
Post Graduate Thesis No
Type of Trial Observational
Type of Study Comparative study
Study Design Other
Public Title of Study Study of relationship between the ratios of lengths of index and ring finger and occu
severity of benign prostatic hyperplasia, a disease resulting in urinary problems, com
aging men.

Scientific Title of Relationship between second to fourth digit ratios and measures of benign prostatic
Study aging men.
Secondary IDs if Any Secondary ID
NIL

Details of Principal
Investigator or overall Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Scientific Name
Query)
Designation
Affiliation
Address

Phone
Fax
Email
 Details Contact
Person (Public Query) Name
Designation
Affiliation
Address

Phone
Fax
Email

Source of Monetary or
Material Support > Dr Manjunatha R
Primary Sponsor
Name
Address

Type of Sponsor

Details of Secondary Name

Sponsor NIL
Countries of List of Countries
Recruitment India
Sites of Study Name of Principal Name of Site
Investigator
Dr Manjunatha R Kempegowda Institute
of Medical Sciences
Hospital and Research
Centre

Details of Ethics Name of Committee Approval Status

Committee
 Name of Committee Approval Status

KIMS-IEC Approved

Regulatory Clearance Status

Status from DCGI Not Applicable
Health Condition / Health Type
Problems Studied Patients

Intervention / Type
Comparator Agent Comparator Agent

Inclusion Criteria
Age From
Age To
Gender
Details

Exclusion Criteria
Details

Method of Generating Not Applicable

Random Sequence
Method of Not Applicable
Concealment
Blinding/Masking Not Applicable
Primary Outcome Outcome
Difference in Second to fourth digit ratios in
patients of BPH and normal healthy volunteers.

Secondary Outcome Outcome

Not applicable

Target Sample Size Total Sample Size=180

Sample Size from India=180
Final Enrollment numbers achieved (Total)=Applicable only for Completed/Termi
Final Enrollment numbers achieved (India)=Applicable only for Completed/Termi
 Total Sample Size=180
Sample Size from India=180
Final Enrollment numbers achieved (Total)=Applicable only for Completed/Termi
Final Enrollment numbers achieved (India)=Applicable only for Completed/Termi

Phase of Trial N/A

Date of First 18/06/2013
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=0
Trial Months=9
Days=0

Recruitment Status of Not Applicable

Trial (Global)
Recruitment Status of Open to Recruitment
Trial (India)
Publication Details
Brief Summary NEED FOR STUDY:
The relative length of 2nd and 4th digit (2D:4D) is a marker for prenatal androgen exp
2D:4D ratio is associated with a high prenatal androgen exposure. Measure of 2D:4
invasive retrospective bio- marker for prenatal androgen exposure is widely adopted
since there are practical difficulties in measuring testosterone exposure in developin
fetus. Exposure to varying levels of androgens in fetal life is found to affect several a
masculinity in males. This may also be true with respect to the growth of prostate in
subsequent hyperplasia in old age. It is found to be linked with prostatic cancer. Stu
been conducted till date to determine the effect of prenatal androgen exposure leve
of prostate gland and BENIGN PROSTATIC HYPERPLASIA (BPH). This study is an
measure of prenatal testosterone exposure and its relation to the development of BP
Objectives of the study:
1) To assess the causal relationship between the 2D:4D ratio and incidence of BPH
2) To quantitatively correlate the 2D:4D ratio with severity of BPH

Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 05:0

CTRI/2013/10/004112 [Registered on: 29/10/2013] - Trial Registered Retrospectiv

 CTRI Number CTRI/2013/10/004112 [Registered on: 29/10/2013] - Trial Registered Retrospectiv
Last Modified On 19/10/2013
Post Graduate Thesis No
Type of Trial Interventional
Type of Study Drug
Study Design Randomized, Parallel Group Trial
Public Title of Study A study to find out the medication which offers maximum health benefits with minim
the patient among the three commonly used medications in the treatment of benign
hyperplasia, a disease in aging men which results in bothersome urinary problems.

Scientific Title of An analysis of the Cost-effectiveness of alfuzosin, tamsulosin and silodosin in benig
Study hyperplasia.
Secondary IDs if Any Secondary ID
NIL

Details of Principal
Investigator or overall Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Scientific Name
Query)
Designation
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Public Query) Name
Designation
Affiliation
 Address

Phone
Fax
Email

Source of Monetary or
Material Support > Dr Manjunatha R
Primary Sponsor
Name
Address

Type of Sponsor

Details of Secondary Name

Sponsor NIL
Countries of List of Countries
Recruitment India
Sites of Study Name of Principal Name of Site
Investigator
Dr Manjunatha R Kempegowda Institute
of Medical Sciences
Hospital and Research
Centre

Details of Ethics Name of Committee Approval Status

Committee
KIMS-IEC Approved

Regulatory Clearance Status

Status from DCGI Not Applicable

Health Condition / Health Type

Problems Studied Patients
 Patients

Intervention / Type
Comparator Agent Comparator Agent
Comparator Agent
Intervention

Inclusion Criteria
Age From
Age To
Gender
Details

Exclusion Criteria
Details

Method of Generating Computer generated randomization

Random Sequence
Method of Sequentially numbered, sealed, opaque envelopes
 Sequentially numbered, sealed, opaque envelopes
Concealment
Blinding/Masking Open Label
Primary Outcome Outcome
Treatment success is defined as 30 percent or
more improvement in International Prostate
Symptom Score (IPSS) from baseline and its
maintenance over the study period

Secondary Outcome Outcome

Not applicable

Target Sample Size Total Sample Size=90

Sample Size from India=90
Final Enrollment numbers achieved (Total)=Applicable only for Completed/Termi
Final Enrollment numbers achieved (India)=Applicable only for Completed/Termi

Phase of Trial Phase 4

Date of First 03/09/2013
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=0
Trial Months=10
Days=0

Recruitment Status of Not Applicable

Trial (Global)
Recruitment Status of Open to Recruitment
Trial (India)
Publication Details
Brief Summary
Several pharmacoe
Pharmacoeconom
conditions.

attention being plac

treatments for BPH ar

and associated cost), consideration of cost-effectiveness analyses can h

new treatment options to facilitate treatment choices.
regarding the cost-effectiveness of alfuzosin, tamsulosin and silodosin
study is taken up.

Objective of the study:

 To compare the cost-effectiveness of alfuzosin, tamsulosin and silodosin in the management of BPH from the patient perspective as assessed by:

a. Average Cost-effectiveness ratio

b. Incremental cost-effectiveness ratio.

 Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 05:0

CTRI Number CTRI/2013/10/004048 [Registered on: 07/10/2013] - Trial Registered Prospective

Last Modified On 04/12/2019
Post Graduate Thesis No
Type of Trial Interventional
Type of Study Drug
Study Design Randomized, Parallel Group, Active Controlled Trial
Public Title of Study A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With
Overactivity Caused By A Neurological Condition
Scientific Title of A 24-week Randomized, Open-label, Study To Evaluate The Safety And Efficacy O
Study In Subjects Aged 6 To 17 Years With Symptoms Of Detrusor Overactivity Associate
Neurological Condition (Neurogenic Detrusor Overactivity)

Secondary IDs if Any Secondary ID

A0221047 Protocol Amendment 5, 3 March 2014
NCT01557244

Details of Principal
Investigator or overall Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Scientific Name
Query)
Designation
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Public Query) Name
Designation
Affiliation
 Address

Phone
Fax
Email

Source of Monetary or
Material Support > Pfizer Inc, 235 East 42nd Street, New York, NY 10017 USA
Primary Sponsor
Name
Address
Type of Sponsor

Details of Secondary Name

Sponsor Nil
Countries of List of Countries
Recruitment Belgium
Canada
Chile
Estonia
France
Greece
India
Italy
Japan
Lithuania
Malaysia
Mexico
Netherlands
Philippines
Republic of Korea
Romania
 Russian Federation
Slovakia
South Africa
Spain
Sweden
Taiwan
Turkey
United Kingdom
United States of America

Sites of Study Name of Principal Name of Site

Investigator
Dr Jugesh Chhatwal Christian Medical
College - Ludhiana

Dr Rajeev Sood Dr. Ram Manohar Lohia

Hospital & PGIMER

Dr Rajendra Kasinath Inamdar Multispeciality

Shimpi Hospital - Pune

Dr Apul Goel King Georges Medical

University - Lucknow

Details of Ethics Name of Committee Approval Status

 Name of Committee Approval Status
Committee
Ethics Committee, Approved
Inamdar Multispeciality
Hospital, Survey
Number 15,
Fathimanagar -
Wanwadi, Behind
KPCT Mall, Pune -
411040, Maharashtra,
India

Institutional Ethics Approved

Committee Room No.
403, 4th Floor,
Administration Block,
PGIMER Building, Dr.
Ram Manohar Lohia
Hospital & PGIMER
New Delhi – 110001

Institutional Ethics Approved

Committee, Christian
Medical College &
Hospital, Brown Road,
Ludhiana – 141 008,
Punjab, India

Institutional Ethics Approved

Committee, King
Georges Medical
University, Chowk,
Lucknow - 226003,
Uttar Pradesh, India

Regulatory Clearance Status

Status from DCGI Approved/Obtained
Health Condition / Health Type
Problems Studied Patients

Intervention / Type
Comparator Agent Intervention
 Intervention

Inclusion Criteria
Age From
Age To
Gender
Details

Exclusion Criteria
Details

Method of Generating Stratified randomization

Random Sequence
Method of Centralized
Concealment
Blinding/Masking Open Label
Primary Outcome Outcome
Maximum cystometric bladder capacity

Secondary Outcome Outcome

Detrusor pressure at maximum bladder capacity.
Presence of Involuntary Detrusor Contractions
(IDC).
Bladder volume at first Involuntary Detrusor
Contractions (IDC).
Bladder compliance.
Mean number of micturitions and/or
catheterizations/day.
Mean number of incontinence episodes/day
Mean urgency episodes/day if applicable.
Mean volume voided per micturition or mean
volume per catheterization

Target Sample Size Total Sample Size=192

Sample Size from India=15
Final Enrollment numbers achieved (Total)=Applicable only for Completed/Termi
Final Enrollment numbers achieved (India)=Applicable only for Completed/Termi

Phase of Trial Phase 3

Date of First 28/02/2018
 Enrollment (India)
Date of First 13/09/2012
Enrollment (Global)
Estimated Duration of Years=7
Trial Months=0
Days=0

Recruitment Status of Open to Recruitment

Trial (Global)
Recruitment Status of Closed to Recruitment of Participants
Trial (India)
Publication Details None as yet
Brief Summary The objective of the study is to find out if the medicine fesotero
useful treatment in children with bladder muscle overactivity ca
neurological condition.
Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 05:0
 CTRI Number CTRI/2013/12/004251 [Registered on: 27/12/2013] - Trial Registered Retrospectiv
Last Modified On 14/10/2021
Post Graduate Thesis No
Type of Trial Interventional
Type of Study Surgical/Anesthesia
Study Design Non-randomized, Active Controlled Trial
Public Title of Study Effect of giving lesser fluids during operation on the kidney functions in patients und
donor renal transplant surgery.
Scientific Title of Effect of intraoperative moderate fluid therapy on the renal allograft outcome in patie
Study living donor renal transplant surgery, a comparative study
Secondary IDs if Any Secondary ID
Nil

Details of Principal
Investigator or overall Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Scientific Name
Query)
Designation
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Public Query) Name
Designation
Affiliation
 Address

Phone
Fax
Email

Source of Monetary or
Material Support > None

Primary Sponsor
Name
Address
Type of Sponsor

Details of Secondary Name

Sponsor NIL

Countries of List of Countries

Recruitment India
Sites of Study Name of Principal Name of Site
Investigator
Dr Divya Srivastava Urology Operation
Theatre

Details of Ethics Name of Committee Approval Status

Committee
SGPGIMS Institute Approved
Ethics Committee

Regulatory Clearance Status

Status from DCGI Not Applicable
Health Condition / Health Type
Problems Studied Patients
 Patients

Intervention / Type
Comparator Agent Intervention

Comparator Agent

Inclusion Criteria
Age From
Age To
Gender
Details

Exclusion Criteria

Details

Method of Generating Not Applicable

Random Sequence
Method of Not Applicable
Concealment
Blinding/Masking Open Label
Primary Outcome Outcome
To evaluate the effect of moderate intraoperative
fluid management on renal allograft function

Secondary Outcome Outcome

To evaluate immediate renal allograft function

To register the
incidence of delayed graft function,
post operative acute tubular
necrosis,
requirement of dialysis in immediate post
operative period.

Total Sample Size=200

Sample Size from India=200
Final Enrollment numbers achieved (Total)=0
Final Enrollment numbers achieved (India)=110
 Target Sample Size Total Sample Size=200
Sample Size from India=200
Final Enrollment numbers achieved (Total)=0
Final Enrollment numbers achieved (India)=110

Phase of Trial N/A

Date of First 05/08/2013
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=0
Trial Months=6
Days=0

Recruitment Status of Not Applicable

Trial (Global)
Recruitment Status of Completed
Trial (India)
Publication Details Not applicable
INTRODUCTION and REVIEW OF LITERATURE:
Brief Summary The treatment of choice for patients with end stage renal disease (ESRD) is renal transplant surgery. Most common complication seen in patients of ESRD is cardiovascular dysfunction. Dia
concentric left ventricular hypertrophy, pericardial effusion and poor contractility and ejection fraction may be present. Most of these patients also have minimal or low renal output making the
volume overload. These two factors combined make the fluid management in these patients highly critical. Traditionally it is a common practice to infuse large volume of fluids to these patien
general recommendation is of keeping mean arterial pressure above 100 mmhg 1 and CVP around 12-14 mmhg 2, PAP > 20 mmHg 3 at the time of reperfusion of the transplanted kidney. Ho
these vulnerable patients to complications of volume overload, and prolonged requirement of ventilator support. Gasperi et al showed that such aggressive approach for fluid management is
grafts performed equally well with lower fluid infusions viz 15ml/kg/hr 4. They showed that a CVP between 7-9 was sufficient for adequate renal outcome without facing problems of volume ov
showed in a retrospective study of 1966 patients that a more restricted intraoperative fluid therapy of < 2500ml showed less risk of chronic allograft dysfunction. They showed two fold greate
patients with intraoperative CVP > 11 mm Hg.
Rationale of the study:
The result of recent studies show that moderate fluid administration during intraoperative period suffices equally well for the functioning of renal allograft as did the previous approach of exce
restricted fluid therapy however prevents the danger of volume overload and extended requirement of post operative ventilation in previously cardiovascular compromised individuals.
Keeping the above facts in mind we decided to conduct a prospective trial enrolling all renal transplant recipients for six months. The intraoperative fluid management would be less than 15 m
between 6-10 mm Hg as compare to high 25 ml/kg/hr and CVP maintained in between 12-15 mm Hg. It was hypothesized that judicious intraoperative fluid therapy alone (while maintaining t
result in any difference in outcome of the allograft.

Primary Objective :

To evaluate the effect of moderate intraoperative fluid

managementon renal allograft function in the immed
operative period till 6 months post operatively.
 Secondary Objective:

To note renal allograft function in immediate po

D10 of surgery.

To register the incidence of delayed graft function

acute tubular necrosis, requirement of dialysis in po
period, acute rejection and compare it with previou

METHODOLOGY:

Location SGPGIMS, Lucknow

Inclusion Criteria: All ESRD patients about to undergo living donor renal transplant surgery at our institute for 6months.

Exclusion criteria: patients not willing to take part in the study.

All patients will be given general anesthesia, paralyzed

on mechanical ventilation in similar pattern.
Analgesia will be administered with
induction as per institute policy. Arterial blood pressures
venous pressures (CVP) will be monitored.
end of surgery and shifted to kidney
management.

FLUID DURING THE SURGERY: The

12-15ml/kg till the vascular anastomosis is complete fol
output replacement is also added to fluid
 time of reperfusion would be between
per kg per hour is noted before reperfusion
given intaoperatively including requirement
are also noted as ml/kg/hr. All patients are to be
a dose of 0.5g/kg 20 mins before reperfusio
will be maintained above 100mm Hg
intermittentboluses of mephentermine will be us
fall in blood pressures after clamp opening.

All the living kidney donors will undergo

anaesthesia. They will receive 1500
solution, supplemented by crystalloid
from the start of the surgery until the renal vess
also receive mannitol 20% 1 g/kg
clamping.

Data To Be Noted :The perioperative hemodynamic factors, central venous pressure (CVP); systolic, diastolic, and mean arterial blood pressu
unclamping of the vessels after completion of the anastomoses (end of ischemia) and after completion of surgery. Fluids administered including
ischemia time, time of onset of urine after releasing clamps and urine output till end of surgery will be recorded. The parameters of renal graft f
10,3m and 6 months as well as urine output 1st hr, day 0,1,2,7,10 days are to be recorded. Episodes of acute graft rejection (ARE), acute tubula

recorded. To define ARE and chronic dysfunction we used the 2007 Banff criteria 6.

The donor parameters, HLA typing of donor and recipient , ultrasonographic size and glomerular filtration rate (GFR) of donor kidney will be noted.

For the purpose of comparison the data of 100 renal transplant recipients operated between june 2011 and may 2012 will be collected in the
transplant record files. During the above mentioned period it was a common practice of the then anaesthesiologist to administer high volumes o

15 mmhg at the time of clamp opening and thereafter.

 The data will then be compared statistically and results interpreted accordingly with help of biostatistics deparment.

REFERENCES:

1. Toth M, Reti V, Gondos T. Effect of recipients’ peri-operative parameters on the outcome of kidney transplantation. Clin Transplant1998; 12: 511–517.

2. Martinez B S, Gasanova I, Adesanya A O Anesthesia for kidney transplantation. A review..J Anesth Clin Res 4: 270.

3. Carlier M, Squifflet JP, Pirson Y, Gribomont B, Alexandre GP. Maximal hydration during anesthesia increases pulmonary arterial pressures a

Oct;34(4):201-4.

4. De Gasperi A, Narcisi S, Mazza E, Bettinelli L, Pavani M, Perrone L, Grugni C, Corti A.Perioperative fluid management in kidney transplantation: is volu

Apr;38(3):807-9.

5. L. Campos,B. Parada, F. Furriel, D. Castelo, P. Moreira, A. Mota.Do Intraoperative Hemodynamic Factors of the Recipient Influence Renal Graft Funct

6. K. Soleza, R. B. Colvinb, L. C. Racusenc, M. Haasc, B. Sisa,d, M. Mengeld et al. Banff 07 Classification of Renal Allograft Pathology: Updates and Fut
 Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 05:0

CTRI Number CTRI/2014/01/004268 [Registered on: 01/01/2014] - Trial Registered Retrospectiv

Last Modified On 31/07/2021
Post Graduate Thesis No
Interventional
 Type of Trial Interventional
Type of Study Surgical/Anesthesia
Study Design Randomized, Parallel Group Trial
Public Title of Study Effect of continuous intravenous infusion of dexmedetomidine and esmolol on patie
hemodynamics and pain after operation in laproscopic urological surgeries.
Scientific Title of Effect of continuous infusion of dexmedetomidine and esmolol on hemodynamic att
Study post operative analgesic requirement in patients undergoing laproscopic urological s
Secondary IDs if Any Secondary ID
NA

Details of Principal
Investigator or overall Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Scientific Name
Query)
Designation
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Public Query) Name
Designation
Affiliation
Address
 Phone
Fax
Email

Source of Monetary or
Material Support > None

Primary Sponsor
Name
Address
Type of Sponsor

Details of Secondary Name

Sponsor NIL

Countries of List of Countries

Recruitment India
Sites of Study Name of Principal Name of Site
Investigator
Dr Divya Srivastava Urology Operation
Theatre

Details of Ethics Name of Committee Approval Status

Committee
SGPGI Institute Ethical Approved
Committee

Regulatory Clearance Status

Status from DCGI Not Applicable
Health Condition / Health Type
Problems Studied Patients
Patients
Patients

Intervention / Type
Comparator Agent Intervention
 Comparator Agent

Inclusion Criteria
Age From
Age To
Gender
Details

Exclusion Criteria
Details

Method of Generating Computer generated randomization

Random Sequence
Method of Pre-numbered or coded identical Containers
Concealment
Blinding/Masking Participant and Investigator Blinded
Primary Outcome Outcome
To compare the hemodynamic effects of
dexmedetomidine and esmolol infusions,
To compare postoperative requirement of
opioids in both groups.

Secondary Outcome Outcome

To compare the time of awakening and
extubation after stopping anesthetic agent

To compare nausea and vomiting and

requirement of antiemetic in post operative
period.
 To study the occurrence of side effects with use
of these drugs.

Target Sample Size Total Sample Size=90

Sample Size from India=90
Final Enrollment numbers achieved (Total)=90
Final Enrollment numbers achieved (India)=0

Phase of Trial N/A

Date of First 13/12/2013
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=0
Trial Months=3
Days=0

Recruitment Status of Not Applicable

Trial (Global)
Recruitment Status of Completed
Trial (India)
Publication Details Not Applicable
Introduction
Brief Summary Laparoscopic surgeries in general are associated with increased hemodynamic responses and the anesthesiologists are required to either increase anesthetic depths to supranormal levels or take help of vasodi
?2 antagonists and ß blockers have been used in previous studies for the same purpose. 1,2,3. Dexmedetomidine is a ?2 antagonist4 and esmolol is ultra short acting ß blocker. Use of both of these drugs has nev
urological surgeries. We will compare the role of continuous infusion of above both drugs and their adverse effects in laparoscopic urological surgeries.

METHODS:

After informed written consent we are planning to study patients undergoing laparoscopic urological surgeries. All the patients will receive balanced general an

protocol. They will be divided randomly into two groups.

 Group D: receiving Dexmedetomidine 1ug/kg loading dose over 15 minutes then an infusion of@ 0.5ug/kg/hr.

Group E : receiving esmolol loading dose 1 mg/kg over 15 minutes then @15 ug/kg/hr.

Isoflurane will be titrated to keep pulse and blood pressure within 25% of baseline, by keeping Bispectral Index(BIS) <60 at all times. Injection atropine 0.0

hypotension greater than 25% of baseline and not improving with decreasing isoflurane and fluid boluses. At the end of surgery patient will be extubated and shifted to post op recovery room.

MEASUREMENTS: Pulse and Blood pressure of patient will be taken at baseline, at intubation , on starting drug, at CO2 insufflations, then every 15 mins,

used, time to awakening and time of extubation, sedation scores, pain scores, post operative analgesic requirement, nausea and requirement of antiemetic in post operative will be studied.

Sample size calculation: There are three

heart rate, blood pressure and post operative
recovery room. The variable total fentanyl
calculation. Considering the significance
0.9 (90%), a standard deviation of 75 ug in the variab
critical difference between two drugs taken
group was 45 patients.

1. Poonam S Ghodhi, Shalini K Thombre, Shalini P Sardesai, Kalpana D Harnagle . Dexmedetomidine

laparoscopic surgery: An observational
Anaesthesiol Clin Pharmacol. 2012 Jul-Sep; 28(3): 334–338

2.Koivusalo AM, Scheinin M, Tikkanen I, et al. Effects of

response to CO2 pneumoperitoneum for
Scand 1998; 42: 510–7

3.Collard V, Mistraletti G, Taqi A, FranciscoJ et al Intraope

the Absence of Opioids Spares Postoperative
Ambulatory Laparoscopic Cholecystectomy Anesth Analg 2007

4. Bloor BC, Ward DS, Belleville JP,

dexmedetomidine in humans: II. Hemodynamic changes Ane
1134–42
 Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 05:0

CTRI Number CTRI/2014/03/004511 [Registered on: 28/03/2014] - Trial Registered Retrospectiv

Last Modified On 17/01/2014
Post Graduate Thesis Yes
Type of Trial Interventional
Type of Study Medical Device
Study Design Randomized, Parallel Group Trial
Public Title of Study a trial to compare pain during Dj stent removal using different techniques- Flexible c
semirigid ureteroscope
Scientific Title of Randomised control trial to compare pain during DoubleJ stent removal using Flexib
Study and Semirigid Ureteroscope
Secondary IDs if Any Secondary ID
NIL

Details of Principal
Investigator or overall Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Scientific Name
Query)
Designation
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Public Query) Name
Designation
Affiliation
 Address

Phone
Fax
Email

Source of Monetary or
Material Support > JIPMER
Primary Sponsor
Name

Address
Type of Sponsor

Details of Secondary Name

Sponsor NIL
Countries of List of Countries
Recruitment India

Sites of Study Name of Principal Name of Site

Investigator
Dr Neeraj Agrawal Department of Urology,
3rd floor, SSB

Details of Ethics Name of Committee Approval Status

Committee
Institute Ethics Approved
Committee(Human
Studies)

Regulatory Clearance Status

Status from DCGI Not Applicable
Health Condition / Health Type
Problems Studied Patients

Intervention / Type
Comparator Agent
 Comparator Agent Intervention

Comparator Agent

Inclusion Criteria
Age From

Age To
Gender
Details

Exclusion Criteria
Details

Method of Generating Computer generated randomization

Random Sequence
Method of Sequentially numbered, sealed, opaque envelopes
Concealment
Blinding/Masking Participant and Investigator Blinded
Primary Outcome Outcome
VAS score of pain

Secondary Outcome Outcome

operative time, VAS score of operative difficulty
and complications
 Target Sample Size Total Sample Size=96
Sample Size from India=96
Final Enrollment numbers achieved (Total)=Applicable only for Completed/Termi
Final Enrollment numbers achieved (India)=Applicable only for Completed/Termi

Phase of Trial N/A

Date of First 10/06/2013
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=2
Trial Months=0
Days=0

Recruitment Status of Not Applicable

Trial (Global)
Recruitment Status of Open to Recruitment
Trial (India)
Publication Details
Brief Summary Ureteral stent mostly Double J stent (DJ stent) which are placed for v
indications like ureterescopic stone removal, PCNL, pyeloplasty, ESW
integral part of urological practice. The stents are usually removed a
weeks after the initial therapeutic procedure. Rigid cystoscope which
for stent removal is associated with discomfort and pain, especially in
patients because of longer urethra. Some studies had compared flex
rigid cystoscopy in terms of patient discomfort and pain but for cysto
without any adjuvant procedure. Flexible cystoscopy(FC) is associate
initial and mantanence costs and in a developing nation like ours cos
implication are important. Soylemez et al used semirigid ureteroscop
cystoscopy and stent removal in both male and female patients and
comparable to flexible cystoscope with lower cost.
Till now no study has compared these different techniques for stent r

male patients and no consensus is there regarding the best tech

designed this study as a RCT for comparing flexible cystoscope
ureteroscope for stent removal in our patients.
 Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 05:0

CTRI Number CTRI/2014/12/005232 [Registered on: 01/12/2014] - Trial Registered Retrospectiv

Last Modified On 15/06/2014
Post Graduate Thesis Yes
Type of Trial Interventional
Type of Study Surgical/Anesthesia
Study Design Single Arm Study
Public Title of Study In patients with poorly functioning obstructed kidneys does relief of obstruction impr
Scientific Title of Does renal function improves after drainage in poorly functioning obstructed kidney?
Study
Secondary IDs if Any Secondary ID
NIL

Details of Principal
Investigator or overall Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Scientific Name
Query)
Designation
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Public Query) Name
Designation
 Affiliation
Address

Phone
Fax
Email

Source of Monetary or
Material Support > Jipmer
Primary Sponsor
Name
Address
Type of Sponsor

Details of Secondary Name

Sponsor NIL
Countries of List of Countries
Recruitment India
Sites of Study Name of Principal Name of Site
Investigator
Sidhartha Kalra Departm

Details of Ethics Name of Committee Approval Status

Committee
Institute Ethics Approved
committee(human
studies)

Regulatory Clearance Status

Status from DCGI Not Applicable
Health Condition / Health Type
Problems Studied Patients

Type
 Intervention / Type
Comparator Agent Intervention

Comparator Agent

Inclusion Criteria
Age From
Age To
Gender
Details

Exclusion Criteria
Details

Method of Generating
Random Sequence
Method of
Concealment
Blinding/Masking
Primary Outcome Outcome
1.To compare the GFR in poorly functioning
obstructed kidney before and after the drainage
using DTPA scan

Secondary Outcome Outcome

1.To study the correlation of measurement of
GFR using DTPA and creatinine clearance
2.To study the factors predicting the functional
recovery

Target Sample Size Total Sample Size=22

Sample Size from India=22
Final Enrollment numbers achieved (Total)=Applicable only for Completed/Termi
Final Enrollment numbers achieved (India)=Applicable only for Completed/Termi
 Total Sample Size=22
Sample Size from India=22
Final Enrollment numbers achieved (Total)=Applicable only for Completed/Termi
Final Enrollment numbers achieved (India)=Applicable only for Completed/Termi

Phase of Trial Phase 3/ Phase 4

Date of First 01/03/2013
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=2
Trial Months=0
Days=0

Recruitment Status of Not Applicable

Trial (Global)
Recruitment Status of Open to Recruitment
Trial (India)
Publication Details
Brief Summary Patients within the age of 15-65 years presenting to Jipmer with Unilaterally obstruc
split function of less than 20% calculated in Diethylene-triamine- penta acetic acid( D
having normal renal parameters will be included inthe study.
These patients will subsequently undergo ultrasound (USG) guided percutaneous
nephrosotmy(PCN) under local anesthesia(LA) and repeat functional assesment wil
six weeks with DTPA and urinary creatinine clearance (CRCl) method.
Improvement in renal function,correlation between glomerular function (GFR) estima
and DTPA and factors affecting improvement will be assesed.

Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 05:0

CTRI/2014/01/004325 [Registered on: 17/01/2014] - Trial Registered Prospective

 CTRI Number CTRI/2014/01/004325 [Registered on: 17/01/2014] - Trial Registered Prospective
Last Modified On 18/09/2015
Post Graduate Thesis No
Type of Trial BA/BE
Type of Study
Study Design Randomized, Parallel Group Trial
Public Title of Study A clinical study to measure the bioequivalence between three formulations of Leupr
11.25 mg (two test formulations of Daewoong and reference formulation of Takeda
prostate carcinoma subjects.

Scientific Title of A Multicentric, Open-Label, Randomized, Three-Treatment, Parallel, Single-Dose C

Study Bioequivalence Study of Subcutaneous Leuprolide Acetate 11.25 mg (Luphere Dep
and Leuprolide Acetate 11.25 mg (Luphere Depot®) –Test 2 (T2) of Daewoong Pha
Co. Ltd., in comparison with Leuprolide Acetate 11.25 mg (Lucrin Depot®) – Refere
Takeda Pharmaceutical Company Ltd., in Male Prostatic Carcinoma Subjects Unde
Therapy

Secondary IDs if Any Secondary ID

CR018-13, Version 1.0 amendment 01 dated
23.09.2013

Details of Principal
Investigator or overall Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Scientific Name
Query)
Designation
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Public Query) Name
Designation
Affiliation
 Address

Phone
Fax
Email

Source of Monetary or
Material Support > Daewoong Pharmaceuticals Co Ltd, 501-2, Samgye-Ri, Pogok Eup, Cheoin Gu Y
Do- 449-814,

Primary Sponsor
Name
Address

Type of Sponsor

Details of Secondary Name

Sponsor Daewoong Pharmaceuticals Co Ltd

Countries of List of Countries

Recruitment India
Sites of Study Name of Principal Name of Site
Investigator
Dr Sankara Mahadev AXON Hospital

Dr Shailesh Shah Body Line Hospitals Pvt

Ltd
Dr Kim Mammen Christian Medical
College

Dr Kapil P Thakkar Excel hospital

Dr Murali Subramanian Guru

Multi S

DrRavi Agarwal Manu Hospital and

Research Centre

Dr Yathish Kumar NRR Hospital

Dr Sudhir Rawal Rajiv Gandhi Cancer

Institute and Research
Centre
 Dr Anil Mandhani Sanjay Gandhi Post
Graduate Institute of
Medical Sciences

DrKCLakshmaiah Srinivasam Cancer

Care Hospital

Details of Ethics Name of Committee Approval Status

Committee
AXON Institutional Approved
Ethics Committee
Bodyline Hospitals Approved
Institutional Ethics
Committee
Divyam ethics Approved
Committee
Institutional Ethics Approved
committe, NRR
Hospital, Banglore
Institutional Ethics Approved
Committee
Institutional Ethics Approved
Committee
InstitutionalEthicsCom Approved
mittee
Rajiv Gandhi Cancer Approved
Institute And Research
Centre
SCCH Institutional Approved
Ethics Committee

Regulatory Clearance Status

Status from DCGI Approved/Obtained
 Approved/Obtained
Health Condition / Health Type
Problems Studied Patients

Intervention / Type
Comparator Agent Intervention

Intervention

Comparator Agent

Inclusion Criteria
Age From
Age To
Gender
Details

Exclusion Criteria
Details
 Method of Generating Computer generated randomization

Random Sequence
Method of Centralized
Concealment
Blinding/Masking Not Applicable
Primary Outcome Outcome
• Cmax
• AUC 0- 42 Day

Secondary Outcome Outcome

• Tmax: Time of the maximum measured serum
concentration.
• Safety and tolerability

Target Sample Size Total Sample Size=42

Sample Size from India=42
Final Enrollment numbers achieved (Total)=
Final Enrollment numbers achieved (India)=

Phase of Trial N/A

Date of First 20/01/2014
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=1
Trial Months=6
Days=0

Recruitment Status of Not Applicable

Trial (Global)
Recruitment Status of Completed
Trial (India)
Publication Details
Brief Summary This study is Multicentric, Open-Label, Randomized, Three-Treatment, Parallel, Sin
Clinical Bioequivalence Study of Subcutaneous Leuprolide Acetate 11.25 mg (Luph
Depot®)-Test 1 (T1) and Leuprolide Acetate 11.25 mg (Luphere Depot®) –Test 2 (T
pharmaceuticals Co. Ltd., in comparison with Leuprolide Acetate 11.25 mg (Lucrin D
Reference (R) of Takeda Pharmaceutical Company Ltd., in Male Prostatic Carcinom
Undergoing Initial Therapy.
The Primary objective will be to determine clinical bioequivalence of test drug (T1 &
active comparator (reference drug). The secondary objective of the study is to moni
events, to ensure safety and tolerability as assessed by reported adverse events, la
investigations and vital signs in the prostate carcinoma patients.
 This study is Multicentric, Open-Label, Randomized, Three-Treatment, Parallel, Sin
Clinical Bioequivalence Study of Subcutaneous Leuprolide Acetate 11.25 mg (Luph
Depot®)-Test 1 (T1) and Leuprolide Acetate 11.25 mg (Luphere Depot®) –Test 2 (T
pharmaceuticals Co. Ltd., in comparison with Leuprolide Acetate 11.25 mg (Lucrin D
Reference (R) of Takeda Pharmaceutical Company Ltd., in Male Prostatic Carcinom
Undergoing Initial Therapy.
The Primary objective will be to determine clinical bioequivalence of test drug (T1 &
active comparator (reference drug). The secondary objective of the study is to moni
events, to ensure safety and tolerability as assessed by reported adverse events, la
investigations and vital signs in the prostate carcinoma patients.

Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 05:0

CTRI Number CTRI/2014/02/004394 [Registered on: 10/02/2014] - Trial Registered Prospective

Last Modified On 31/05/2018
Post Graduate Thesis No
Type of Trial BA/BE
Type of Study
Study Design Randomized, Crossover Trial
Public Title of Study Comparative BE study of Everolimus 10 mg tablet OD manufactured by Par Pharma
10977,USA with Afinitor10 mg tablet manufactured by Novartis Pharma Stein AG S
in Advanced Renal Cell Carcinoma patients under fasting condition.

Scientific Title of A Multicenter, randomized, open label, two treatment, two period, two sequence, mu
Study cross-over, bioequivalence study of Everolimus 10 mg tablet once daily manufactur
Pharmaceutical, Inc. 1 Ram Ridge Road, Spring Valley, NY 10977,USA with Afinito
10 mg tablet manufactured by: Novartis Pharma Stein AG Stein, Switzerland and D
Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 in Advance
Carcinoma patients under fasting condition
 A Multicenter, randomized, open label, two treatment, two period, two sequence, mu
cross-over, bioequivalence study of Everolimus 10 mg tablet once daily manufactur
Pharmaceutical, Inc. 1 Ram Ridge Road, Spring Valley, NY 10977,USA with Afinito
10 mg tablet manufactured by: Novartis Pharma Stein AG Stein, Switzerland and D
Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 in Advance
Carcinoma patients under fasting condition

Secondary IDs if Any Secondary ID

13-VIN-537 study protocol version 01 dated
20-Dec-2013

Details of Principal
Investigator or overall Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Scientific Name
Query)
Designation
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Public Query) Name
Designation

Affiliation
 Affiliation
Address

Phone
Fax
Email

Source of Monetary or
Material Support > Par Pharmaceutical,Inc.
Primary Sponsor
Name
Address
Type of Sponsor

Details of Secondary Name

Sponsor Veeda clinical research Pvt Ltd

Countries of List of Countries

Recruitment India
Sites of Study Name of Principal Name of Site
Investigator
Dr Shankar Mahadev Axon Hospital

Dr Gopichand City Cancer centre

 Dr K C Lakshmia Srinivasam cancer care
hospitals India Pvt Ltd

Dr Mukesh Mysore Medical College

and Research Institute

Mysore, 570001
Mysore
KARNATAKA
Dr Arun Dr. GVN Cancer Department of Medical
Institute, Oncology, No. 46
Singaralhope,
Trichy-620008, Tamil
Nadu, India
Tiruchirappalli
TAMIL NADU

Dr K N Srinivasan Dr. G Vishwanathan Oncology OPD, Ground

Speciality Hospital Floor, No. 27, Babu
Road, Trichy-620008,
Tamilnadu
Tiruchirappalli
TAMIL NADU

Dr K Velavan Erode Cancer Centre Erode Cancer Centre,

Velavan Nagar, (Near
Chinthamani petrol
punk) Thindal (PO),
Peruindurai Road,
Erode-638012
Erode
TAMIL NADU

Dr CT Satheesh Sri Venkateshwara Third Floor, Clinical

Hospital Research Department,
No. 86 , Hosur Main
road, Madiwala,
Bangalore, 560068
Bangalore
KARNATAKA
Dr M Kamble Government Medical Department of
College and Hospital Radiation therapy and
Oncology, Room No.
85, Vishwakarma
Nagar, Nagpur-440003,
Maharashtra, India
Nagpur
MAHARASHTRA

Dr Suresh Dubhashi Vintage Hospital & Department of General

Medical Research Surgery, 1st floor,
Centre Pvt Ltd Caculo Enclave,
St.Inez, Panaji,
Goa-403001
South Goa
GOA

Dr Amit Bhatt Sanjeevan Hospital First Floor, Research

Room No. 104, Plot No.
23, Opposite Karve
Road, Erandawane,
Pune-411004
Pune
MAHARASHTRA

Dr Mahesh Desai Muljibhai Patel Society Urology Ofice,

for Research in Dr.Virendra Desai
Nephro-Urology Road, Nadiad-387-001,
Gujarat, India
Kheda
GUJARAT

Dr OP Sharma S.M.S Medical College Department of

& Attached Hospital’s Radio-Oncology, J.L.N
Marg, Jaipur- 302004
Jaipur
RAJASTHAN

Dr A V S Suresh BIBI General Hospital & Third Floor, Clinical

Cancer center Research,
16-3-991/1/c, Govt
Printing press road,
Malakpet, Hyderabad,
500024, AP, India
Hyderabad
ANDHRA PRADESH
Dr Ravindra Deshmukh Jasleen Hospital Kidney Centre,
Panchsheel Square,
Wardha Road,
Nagpur-440012,
Maharashtra, India
Nagpur
MAHARASHTRA

Dr Ketan Shukla New Civil Hospital and Department of Urology,

B.J.Medical College Asarwa,
Ahmedabad-380016,
Gujarat, India
Ahmadabad
GUJARAT

Dr Vinay Tomar S.M.S Medical College Department of Urology,

& Attached Hospital’s J.L.N Marg, Jaipur-
302004
Jaipur
RAJASTHAN

Dr Minish Jain Noble Hospital, Pvt ltd Ground Floor, Clinical

Research Room,153,
Magarpatta city road,
Hadapsar, Pune
411013 Maharashtra ,
India
Pune
MAHARASHTRA

Dr JK Singh SS Hospital Clinical Research

Room, Doctors Colony
Malahi Parki Chowk,
Kankar bagh, Patna,
Bihar-800020
Patna
BIHAR

Dr Senapati Acharya Harihar Department of

Surendranath Regional Cancer Radiation Oncology,
Centre , Medical Road,
Mangalabag, Cuttac,
Odisha
Cuttack
ORISSA

Dr Ajay Mehta Central India Cancer Ground floor, Clinical

Research Institute Research Department,
11, Shankr Nagar, Wes
High Court, Nagpur,
440010 Maharastra
Nagpur
 MAHARASHTRA
Dr Kirushna Kumar Meenakshi mission Department of
hospital and research Oncology,Lake
center, area,Merul road,
Madurai,Tamilnadu,
625107
Madurai
TAMIL NADU

Dr Raghunath SK HCG Bangalore HCG tower No. 4 , Fifth

Institute of Oncology Floor,Room No. 512,
Lane No. 8, P. Kalinga
Rao road,
Sampangiram Nagar,
Bangalore – 560027,
Karnataka , India
Bangalore
KARNATAKA

Dr Kaustubh Kulakarni Aster Aadhar Hospital Department of Surgery,

(Prerana Hospital Ltd.) Near Shashtri Nagar,
KMT Workshop,
Kolhapur,
Maharashtra-416012
Kolhapur
MAHARASHTRA

Dr Shailesh Shah Bodyline Hospital Research Room,

Ground Floor, Opp.
Anupama Hall, Near
Dev Status, New Vikas
Gruh Road, Paldi,
Ahmedabad-380007,
Gujarat, India
Ahmadabad
GUJARAT

Dr Bharat Rangarajan Narayana Hrudayalaya Department of Medical

Hospital Oncology, Mazumdar
Shaw Medical
Centre,NH Health City,
7th Floor 258/A
Bommasandra
Industrial Area Anekal
Taluk, Bangalore - 560
099, Karnataka, India
Bangalore
KARNATAKA

Dr Ranjan Mahoprata Global Hospital and Departement of Medica

Health city Oncology, # 439,
Cheran nagar,
Perumbakkam,
Chennai - 600100
Chennai
TAMIL NADU
Dr Jadhav B. J .Government First Floor, Department
Medical College and of Surgery, Ward no.
Sassoon 10, Sassoon Road,
Somwar Peth, Pune, 41
1001, Maharashtra,
India
Pune
MAHARASHTRA

Dr Rajneesh Nagarkar Curie Manavata cancer

centre

Dr Rakesh Neve Maharastra Medical

Foundation Joshi
Hospital

Inamdar multispecialty Inamdar multispecialty

Hospital Hospital

Details of Ethics Name of Committee Approval Status

Committee
Axon Institutional Ethics Approved
Committee/Hyderabad/
Dr.Shankar Mahadev
Institutional Ethics Approved
Committee, City Cancer
Centre/vijaywada/Dr.Go
pichand
 Institutional Ethics Approved
Committee, Srinivasam
cancer care hospital
India Pvt. Ltd./Bangalor
e/Dr.K.C.Lakshmia

Ethics Committee, Submittted/Under

Mysore medical college Review
& research
Institute/Mysore/Dr.
Mukesh

Dr. GVN Cancer Approved

Institute, Institutional
Ethics Committee/Trich
y/Dr.Arun

Hospital Ethics Approved

Committee, Dr.G.Viswa
nathan Specialty Hospit
als/Trichy/Dr.K.N.Sriniv
asan

Institutional Ethics Approved

Committee, Erode
Cancer Centre/Erode/D
r.K.Velavan

Sri Venkateshwara Approved

Hospital Ethics Committ
ee/Bangalore/Dr. CT

Satheesh
Office of Ethics Approved 01/02/2014
Committee,
Government Medical
College/Nagpur/Dr. K.
Kamble

Vintage Institutional Approved 07/02/2014

Ethics
Committee/Goa/Dr.
Suresh Dubhashi

Ethics Committee Approved 01/02/2014

Sanjeevan
Hospital/Pune/Dr. Amit
Bhatt
Muljibhai Patel Society Approved 26/03/2014
For Research in Nephro
Urology Ethics
Committee/Nadiad/Dr.
Mahesh Desai

Office of Ethics Submittted/Under No Date Specified

Committee of SMS Review
Hospital and associated
hospitals/Jaipur/Dr.O.P.
Sharma

BIBI Institutional Ethics Submittted/Under No Date Specified

Committee/Hyderabad/ Review
Dr.AVS Suresh
Jasleen Hospitals Approved 03/02/2014
Ethics
Committee/Nagpur/Dr.
Ravindra Deshmukh

Institutional Ethics Submittted/Under No Date Specified

Committee, B.J Medical Review
College and Civil Hospit
al/Ahmedabad/Dr.Ketan
Shukla

Office of Ethics Submittted/Under No Date Specified

Committee of SMS Review
Hospital and associated
hospitals/Jaipur/Dr.Vina
y Tomar

Insitutional Ethics Approved 20/02/2014

Committee Noble
Hospital/Pune/Dr.Minis
h Jain

Institutional Ethics Approved 01/03/2014

Committee SS Hospital
and Research Centre/P
atana/Dr.J.K.Singh

Acharya Harihar Submittted/Under No Date Specified

Regional Cancer Review
Centre, Institutional
Ethics
Committee/Cuttac/Dr.
Senapati Surendranath

Institutional Ethics Approved 12/02/2014

Committee, Centre
India Cancer Research
 Institute /Nagpur/Dr.Aja
y Mehta
Institutional Ethics Approved
Committee, Meenakshi
Mission Hospital &
Research Centre/

HCG, Central Ethics Co Approved

mmittee/Bangalore/Dr.
Raghunath S.K.
Aster Aadhar ethics Approved
committee/Kolhapur/Dr.
Kaustubh Kulakarni
Institutional Ethics Approved
Committee Bodyline Ho
spital/Ahmedabad/Dr.S
hailesh Shah

Narayana Hrudayalaya Submittted/Under

Medical Ethics Committ Review
ee/Bangalore/Dr.
Bharat Rangarajan

Institutional Ethics Approved

Committee B J Medical
College and Sasoon
General Hospital,
Pune/Pune/Dr.Jadhav

Institutional Ethics Submittted/Under

committee - GLobal Review
Hospitals & Health city
/Chennai/Dr. Ranjan
Mahoprata

Ethics committee of Submittted/Under

Inamdar Multispeciality Review
Hospital/Pune/Dr.Tusha
r Patil

Institutional ethics Approved

committee Maharastra
Medical research
society/Pune/Dr.Rakes
h Neve

Manavata Clinical Approved

research Institute Ethics
committee (MCRI EC)/
Nasik/Dr.Rajaneesh
Nagarkar

Regulatory Clearance Status

Status from DCGI No Objection Certificate
Health Condition / Health Type
Problems Studied Patients
Intervention / Type
Comparator Agent
 Comparator Agent Intervention

Comparator Agent

Inclusion Criteria
Age From
Age To
Gender
Details

Exclusion Criteria
 Details

Method of Generating Other

Random Sequence
Method of An Open list of random numbers
Concealment
Blinding/Masking Open Label
Outcome
 Primary Outcome Outcome
•To compare and evaluate the multiple-dose oral
bioavailability of Everolimus 10 mg tablet once
daily manufactured by Par Pharmaceutical, Inc.
1 Ram Ridge Road, Spring Valley, NY 10977
USA, with Afinitor (Everolimus) 10 mg tablet
manufactured by: Novartis Pharma Stein AG
Stein, Switzerland and Distributed by: Novartis
Pharmaceuticals Corporation East Hanover,
New Jersey 07936 in Advanced renal cell
carcinoma patients under fasting condition.

Secondary Outcome Outcome

To monitor the adverse events and to ensure the
safety of Patient

Target Sample Size Total Sample Size=48

Sample Size from India=48
Final Enrollment numbers achieved (Total)=
Final Enrollment numbers achieved (India)=

Phase of Trial N/A

Date of First 17/02/2014
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=1
Trial Months=0
Days=0

Recruitment Status of Not Applicable

Trial (Global)
Recruitment Status of Completed
Trial (India)
Publication Details Not Applicable
Brief Summary A Multicenter, r
multiple-dose, c
daily manufa
Valley, NY 10
by: Novartis Ph
Pharmaceuticals
Cell Carcinom
will be enrol
duration o
administration in
 day 29 of the study. There will be a no washout period of between
For each patient, a total of 34 PK samples will be collected during
Patient will also be provided with a patient diary card to enter
drug consumption at his/her home. Patient will be provided with ade
instructions to complete the patient diary card at his/her home.
dosing will be assessed by checking the patients diary for IMP co
home, pasting the duplicate label of dispensed container on th
of individual Case Report Form (CRF). Patients who complete
withdrawn will have to go safety assessments immediately after th
administration or last PK sample collection in period II. A telepho
follow up will be done for all the randomized patients till 30 day
IMP administration in the study.
 Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 05:0

CTRI Number CTRI/2015/03/005626 [Registered on: 12/03/2015] - Trial Registered Retrospectiv

Last Modified On 10/03/2015
Post Graduate Thesis Yes
Type of Trial Interventional
Type of Study Surgical/Anesthesia
Study Design Randomized, Crossover Trial
Public Title of Study Does the use of a special (blue-green) colored light for removing bladder tumours h
the rate amount of tumour detected in cases of bladder cancer ?
Scientific Title of The impact of narrow band imaging (NBI) in the detection of bladder tumour in trans
Study carcinoma of the bladder: A randomized crossover controlled trial from a tertiary car
India.

Secondary IDs if Any Secondary ID

Nil

Details of Principal
Investigator or overall Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Scientific Name
Query)
Designation
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Public Query) Name
Designation
Affiliation
 Address

Phone
Fax
Email

Source of Monetary or
Material Support > instititutional Review Board, Fluid research grant
Primary Sponsor
Name
Address

Type of Sponsor

Details of Secondary Name

Sponsor NONE

Countries of List of Countries

Recruitment India
Sites of Study Name of Principal Name of Site
Investigator
Partho Mukherjee Christian Medical
College, Vellore

Details of Ethics Name of Committee Approval Status

Committee
institutional Review Approved
Board, Christian
Medical College,
Vellore

Regulatory Clearance Status

Status from DCGI Not Applicable
Health Type
 Health Condition / Health Type
Problems Studied Patients
Intervention / Type
Comparator Agent Intervention
Comparator Agent White light TURT
Inclusion Criteria
 Age From
Age To
Gender

Details

Exclusion Criteria
Details

Method of Generating Permuted block randomization, variable

Random Sequence
Method of Sequentially numbered, sealed, opaque envelopes
Concealment
Blinding/Masking Outcome Assessor Blinded
Primary Outcome Outcome
1. Number of tumours detected by either
modality: The pathologist will report the presence
of malignancy, if detected, in both samples. The
extra number of lesions,
(tumours/ CIS), if reported, will be correlated to
the type of light source used and will be used for
statistical analysis. Negative reports will also be
noted.
2.Completeness of resection

Secondary Outcome Outcome

NIL

Target Sample Size Total Sample Size=190

Sample Size from India=190
Final Enrollment numbers achieved (Total)=Applicable only for Completed/Termi
Final Enrollment numbers achieved (India)=Applicable only for Completed/Termi

Phase of Trial Phase 1/ Phase 2

01/08/2013
 Date of First 01/08/2013
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=1
Trial Months=5
Days=0

Recruitment Status of Not Applicable

Trial (Global)
Recruitment Status of Open to Recruitment
Trial (India)
Publication Details Planned for publication in an indexed journal after compilation of data and results.
Brief Summary Introduction : Bladder cancer is a common urological maligna
incidence of over 60,000 cases per year in the US. The majorit
patients will develop recurrences usually also of low grade. On
important factors which cause recurrence among bladder tumo

is the field change of the entire transitional urothelium whic

exposure to the carcinogen. Standard wh
been the traditional modality in inspection and resection of
however has its limitations in identifying tumour, more so
band imaging has been used to advantage in gastroenterologi
endoscopic studies. Its benefit in enhancing the detection of
tumours has also been reported. A significantly higher overal
detection rate was described for NBI cystoscopy versus
literature.

Methods and materials: Randomized

narrow band imaging and white light assisted cystoscop
resection of bladder tumours. 95 patients
diagnosed to have bladder cancer with single or multipl
tumour WL cystoscopy proceed TURT
visible gross and suspicious lesions followed
and bladder wash. This will be immediately
and (If needed) TURT of lesions newly detected under
 a crossover. The reverse of this will be done for the ot

Results: The overall increase in tumour

second modality of light in each arm will
white light will be noted. This value
significance.

Conclusions: This study will serve the

of NBI in the management further, and, if proven benefi
as a standard modality for the treatment of bladder cancer in I

Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 05:0

CTRI Number CTRI/2014/03/004463 [Registered on: 10/03/2014] - Trial Registered Prospective

Last Modified On 12/06/2014
Post Graduate Thesis No
Type of Trial PMS
Type of Study Drug
Study Design Single Arm Study
study to evaluate the effectiveness and safety of Silodal (silodosin) in Indian male p
lower urinary tract symptoms
 Public Title of Study study to evaluate the effectiveness and safety of Silodal (silodosin) in Indian male p
lower urinary tract symptoms
Scientific Title of A prospective, open-label, multi-center, post-marketing study to evaluate the efficac
Study Silodal (silodosin) in Indian male patients with lower urinary tract symptoms associa
prostatic hyperplasia.

Secondary IDs if Any Secondary ID

PMS/SIL/1013/Ver 1; 25th October 2013

Details of Principal
Investigator or overall Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Scientific Name
Query)
Designation
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Public Query) Name
Designation
Affiliation
Address
 Phone
Fax
Email

Source of Monetary or
Material Support > Ranbaxy Laboratories Ltd, Western Edge-I, Unit no. 201-204, 2nd Floor, Western
Highway, Borivali (E), Mumbai- 400066

Primary Sponsor
Name
Address

Type of Sponsor

Details of Secondary Name

Sponsor NIL
Countries of List of Countries
Recruitment India
Sites of Study Name of Principal Name of Site
Investigator
Dr Rajesh Bajpai Advanced urology and
Lithotripsy clinic,

DrSwapan Sood Patel Hospital

DrCSRatkal Ratkal Speciality

Hospital,

Dr Amitava Mukerjee RG Stone Urological

research institute

DrHemendra Shah urolap superspeciality

clinic,

Name of Committee Approval Status

 Details of Ethics Name of Committee Approval Status
Committee
EC-IEC (Thane- Approved
Maharashtra)
EC-IEC (Thane- Approved
Maharashtra)

Regulatory Clearance Status

Status from DCGI Not Applicable

Health Condition / Health Type

Problems Studied Patients

Intervention / Type
Comparator Agent Intervention
Comparator Agent

Inclusion Criteria
Age From
Age To
Gender
Details

Exclusion Criteria
 Details

Method of Generating Not Applicable

Random Sequence
Method of Not Applicable
Concealment

Blinding/Masking Open Label

Primary Outcome Outcome
the change in BPH symptoms as assessed by
changes in International Prostate Symptom
 Score (IPSS)
Secondary Outcome Outcome
change in urinary flow rate measured by change
from baseline in Qmax.
improvement in voiding and storage symptoms
by Percentage change in IPSS voiding and
storage sub scores
change from baseline in QOL due to urinary
symptoms
Evaluate the percentage of treat
achieving decrease in IPSS score from baseline
of ?25%.
Evaluate the percentage of treat
achieving improvement in Qmax from baseline o
?30%.
• Evaluation of Safety and tolerability by
evaluating the incidence and severity of adverse
events (AEs)
Target Sample Size Total Sample Size=250
Sample Size from India=250
Final Enrollment numb
Final Enrollment numb
Phase of Trial Post Marketing Surveillance
Date of First 20/03/2014
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=0
Trial Months=6
Days=0
Recruitment Status of Not Applicable
Trial (Global)
Recruitment Status of Suspended
Trial (India)
Publication Details
Brief Summary

Study Plan

ü At the first visit (Baseline), detailed history and examination of the

will be performed. Patients will be recruited based on the inclusio
exclusion criteria. Written ‘Informed consent’ will be obtained from
patients after a thorough explanation of the study. Patients will be
explained regarding benefits and side effects of the treatment as
available Prescribing Information.

ü Commercially av
investigator and w
 patients will be advised to self-administer the
capsules taken orally once daily with a meal.

ü There will be a minimum of 6 visits during the study namely at baseline, on

the day of first dose (post 2 hours), day 3, week 1, week 4 and week 12.

ü At the baseline visit, the patient’s medical history will be taken including the
BPH symptoms, IPSS score and physical examination. The other
assessments include, uroflowmetry to assess void volume, Qmax and
residual volume, ultrasound to assess prostate volume, urine routine, basic
renal (S.creatinine) and Liver (AST/ALT) function tests, and ECG to rule
out any cardiac abnormalities that would contra-indicate Silodal.

ü Patients who are enrolled into the study will be followed up at

week 1 (for IPSS) and BP measurements (supine and sitting)
any early adverse events notably postural hypotension.

ü On completion of week 4 patients will be assesses for IPSS, vital signs, BP

measurements (supine and sitting) to rule out any early adverse events
notably postural hypotension and uroflowmetry.

ü The final study visit will be at week 12, at which along with IPSS, there will
be end of study assessments for uroflowmetry, BP measurements (supine
and sitting) to rule out any early adverse events notably postural
hypotension and basic renal (S.creatinine) and Liver (AST/ALT) function
tests.

ü Safety will be monitored throughout the study.

Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 05:0
 Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 05:0

CTRI Number CTRI/2014/09/004999 [Registered on: 10/09/2014] - Trial Registered Retrospectiv

Last Modified On 20/08/2014
Post Graduate Thesis No
Type of Trial Interventional
Type of Study Drug
Study Design Randomized, Parallel Group, Active Controlled Trial
Public Title of Study A research study to explore the occurrence of side effects of darifenacin and trospiu
two drugs used in the treatment of patients with increased frequency of urination, ur
with or without urinary leakage

Scientific Title of A prospective, randomized, single blind study of ocular side effects of darifenacin an
Study overactive bladder.
Secondary IDs if Any Secondary ID
NIL

Details of Principal
Investigator or overall Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Scientific Name
Query)
Designation
Affiliation
Address

Phone
 Fax
Email

Details Contact
Person (Public Query) Name
Designation
Affiliation
Address

Phone
Fax
Email

Source of Monetary or
Material Support > self, Dr Manjunatha R

Primary Sponsor
Name
Address

Type of Sponsor

Details of Secondary Name

Sponsor NIL

Countries of List of Countries

Recruitment India
Sites of Study Name of Principal Name of Site
Investigator
 Dr Manjunatha R Department of Urology,
KIMSH & RC

Details of Ethics Name of Committee Approval Status

Committee
KIMS-IEC Approved

Regulatory Clearance Status

Status from DCGI Not Applicable
Health Condition / Health Type
Problems Studied Patients

Intervention / Type
Comparator Agent Intervention

Comparator Agent

Inclusion Criteria
Age From

Age To
Gender
 Details

Exclusion Criteria
Details

Method of Generating Random Number Table

Random Sequence
Method of Not Applicable
Concealment
Blinding/Masking Investigator Blinded
Primary Outcome Outcome
change in accommodation amplitude, pupillary
diameter, schirmer 1 and 2 tests and tear film
break-up time between the two treatment
groups.

Secondary Outcome Outcome

 change in accommodation amplitude and

pupillary diameter
Target Sample Size Total Sample Size=30
Sample Size from India=30
Final Enrollment numbers achieved (Total)=Applicable only for Completed/Termi
Final Enrollment numbers achieved (India)=Applicable only for Completed/Termi

Phase of Trial Phase 4

Date of First 28/11/2013
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=0
Trial Months=7
Days=0

Recruitment Status of Not Applicable

Trial (Global)
Recruitment Status of Open to Recruitment
Trial (India)
Publication Details
Brief Summary Darifenacin and trospium are the two antimuscarinics with similar efficacy which is n
other antimuscarinics and hence commonly used in the treatment of OAB.
The most common adverse events during darifenacin treatment were dry mouth (re
of patients) and constipation (14.1%) and the incidence of dry eye is reported to be
with darifenacin 7.5mg and 15mg respectively in its product information. The P-glyc
drug efflux transporter liabilities of darifenacin may limit its penetration into brain and
thereby reducing side effect potential.11
Trospium chloride is a quaternary ammonium compound which is non?selective for
receptor and is a substrate for p-gp efflux transporter. It crosses the blood–brain ba
extent and hence would appear to have few cognitive effects. However, there are no
studies demonstrating its transport across Blood ocular barrier which also is equipp
efflux transporter. The incidence of dry eye with trospium 20mg is 1.2% in its produc
2012.
There is less direct evidence of whether darifenacin and trospiu
exerts less ocular side effects due to its unique properties. Hen
present study was taken up to evaluate the same
 Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 05:0

CTRI Number CTRI/2014/08/004811 [R

Last Modified On 29/11/2018
Post Graduate Thesis Yes
Type of Trial Interventional
Type of Study Drug
Study Design Randomized, Parallel Group, Placebo Controll
Public Title of Study ‘Tamsulosin and darifenac
accompanying overactive bladder’
Scientific Title of Efficacy and safety of ‘t
Study with accompanying overactive bladd
Secondary IDs if Any Secondary ID
NIL

Details of Principal
Investigator or overall Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
 Address

Phone
Fax
Email

Details Contact
Person (Scientific Name
Query)
Designation
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Public Query) Name
Designation
Affiliation
Address

Phone

Fax
Email

Source of Monetary or
Material Support > University College of Medical Sciences University of Delhi Delhi110095
Primary Sponsor
 Name
Address

Type of Sponsor

Details of Secondary Name

Sponsor NIL
Countries of List of Countries
Recruitment India
Sites of Study Name of Principal Name of Site
Investigator
Dr IQBAL SINGH UCMS GTBH

Details of Ethics Name of Committee Approval Status

Committee
Institutional Ethics Approved
Committee
(EC)-HUMAN
RESEARCH(IEC-HR),
University College of
Medical Sciences,
Delhi-110095. India
Independent Ethics
Committee

Regulatory Clearance Status

Status from DCGI Not Applicable
Health Condition / Health Type
Problems Studied Patients

Patients

Intervention / Type
Comparator Agent Intervention

Comparator Agent
 Inclusion Criteria
Age From
Age To
Gender
Details

Method of Generating Computer generated randomization

Random Sequence
Method of Case Record Numbers
Concealment
Blinding/Masking Not Applicable
Primary Outcome Outcome
Mean change from baseline to week 8 in number
of urinary frequencies in 24 hours and mean
change in number of incontinence episodes per
day that resulted in change in clothing.

Secondary Outcome Outcome

Mean change from baseline to week 8 in number
of voiding episodes per night, mean change in
PVR and total IPSS.
Target Sample Size Total Sample Size=60
Sample Size from India=60
Final Enrollment numbers achieved (Total)=
Final Enrollment numbers achieved (India)=
 Phase of Trial N/A
Date of First 01/11/2012
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=1
Trial Months=4
Days=0
Recruitment Status of Not Applicable
Trial (Global)
Recruitment Status of Completed
Trial (India)
Publication Details Not applicable
Brief Summary Rationale: BPH i
of global literatur
versus tamsulosin monotherapy in patien

Aims & Objectives: To compare the efficacy of

‘tamsulosin monotherapy’ for symptomatic BPH
tolerability and safety of ‘tamsulosin and darifenacin’
symptomatic BPH with accompanying OAB.

Methods: This study included symptomatic patients of BPH with any o

OAB symptoms; micturition frequency >8 , nocturia
Nov’2012 and Feb’2014. After protocol approval by local ethics commit
consent, patients were randomly assigned to receive either tamsulosin
(n=30) or tamsulosin 0.4 mg plus darifenacin 7.5 mg (T+D) (n=30) for 8
the urinary frequency and incontinence episodes/24
frequency; mean change in PVR and changes i
between both groups at 0/eight week. n

Results: The mean change in frequency, incontinence

and IPSS were (-4.83 vs. -3.93, p=0.023), (-1.50 vs.-1.08, p=0.001), (-2
(-7.90 vs. -6.27, p=0.000) in the T+D/T+P group respectively (significa
side effects (12 vs. 9) all interventions appeared to be safe and well to
mean change in the PVR was marginal (+10.84ml and -16.93) in the T+
and the incidence of urinary retention was 13%

Conclusions: Treatment with tamsulosin and darifenacin

treatment modality in select patients of BPH with accompanying OAB symptoms.
 Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 05:0

CTRI Number CTRI/2014/07/004731 [Registered on: 11/07/2014] - Trial Registered Retrospectiv

Last Modified On 10/07/2014
Post Graduate Thesis No
Type of Trial Interventional
Type of Study Surgical/Anesthesia
Study Design Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study A randomized controlled trial to evaluate the efficacy of Pelvic plexus block in pain r
the biopsy of prostate
 A randomized controlled trial to evaluate the efficacy of Pelvic plexus block in pain r
the biopsy of prostate
Scientific Title of Pelvic plexus block: An endeavour to reduce pain during transrectal ultrasound guid
Study prostate
Secondary IDs if Any Secondary ID
Nil

Details of Principal
Investigator or overall Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Scientific Name
Query)
Designation
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Public Query) Name
Designation
Affiliation
Address
 Phone
Fax
Email

Source of Monetary or
Material Support > None

Primary Sponsor
Name
Address

Type of Sponsor

Details of Secondary Name

Sponsor NIL

Countries of List of Countries

Recruitment India
Sites of Study Name of Principal Name of Site
Investigator
Tarun Jindal department of Urology,
Calcutta National
medical College

Details of Ethics Name of Committee Approval Status

Committee
Ethical committee of Approved
Calcutta National
Medical College

Regulatory Clearance Status

Status from DCGI Not Applicable
Health Condition / Health Type
Problems Studied Patients

Intervention / Type
Comparator Agent Comparator Agent

Intervention
 Intervention

Inclusion Criteria
Age From
Age To
Gender

Details

Exclusion Criteria
Details

Method of Generating Computer generated randomization

Random Sequence
Method of On-site computer system
Concealment
Blinding/Masking Participant, Investigator and Outcome Assessor Blinded
Primary Outcome Outcome
The effect of pelvic plexus block as compared to
the pei prostatic block and placebo on the pain
during prostate biopsy

Secondary Outcome Outcome

The complications occuring due to the biopsy
procedure

Target Sample Size Total Sample Size=139

Sample Size from India=139
Final Enrollment numbers achieved (Total)=
Final Enrollment numbers achieved (India)=

Phase of Trial N/A

Date of First 10/01/2012
 10/01/2012
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=1
Trial Months=6
Days=0

Recruitment Status of Not Applicable

Trial (Global)
Recruitment Status of Completed
Trial (India)
Publication Details None yet
Brief Summary The best technique of analgesia for prostate biopsy is still controversial. We evaluat
pelvic plexus block on the pain due to prostate biopsy and compare it with the conve
periprostatic block. we also have a placebo arm in our study to assess the overall b
techniques

Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 05:0

CTRI Number CTRI/2014/09/005065 [Registered on: 25/09/2014] - Trial Registered Prospective

Last Modified On 23/11/2016
Post Graduate Thesis No
Type of Trial Interventional
Type of Study Drug
Study Design Single Arm Study
Public Title of Study The study of drug used for the Reversal of Anticoagulant Effects of Dabigatran (Pra
Scientific Title of (Protocol No. 1321.3):A Phase III, case series clinical study of the reversal of the an
Study effects of dabigatran by intravenous administration of 5.0g idarucizumab (BI 655075
treated with dabigatran etexilate who have uncontrolled bleeding or require emerge
procedures.

Secondary IDs if Any Secondary ID

1321.3, Version 1.0 dated 23 Dec 2013
 Details of Principal
Investigator or overall Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Scientific Name
Query)
Designation
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Public Query) Name
Designation
Affiliation
Address

Phone

Fax
Email
 Source of Monetary or
Material Support > Boehringer Ingelheim
Primary Sponsor
Name
Address

Type of Sponsor

Details of Secondary Name

Sponsor NIL
Countries of List of Countries
Recruitment Argentina
Australia
Belgium
Canada
China
Germany
Hong Kong
India
Poland
Portugal
Sweden
Switzerland
United Kingdom
United States of America

Sites of Study Name of Principal Name of Site

Investigator
Dr M V Padma All India Institute of
Srivastava Medical Sciences
(AIIMS)

Dr Santosh Kumar Dora Asian Heart Institute

Dr Dhiman Kahali B.M. Birla Heart

research Centre
 Dr Varun Bhargava Care Hospitals

440010
Nagpur
MAHARASHTRA
Dr Upendra Kaul Fortis Escorts Heart Department of
Institute Cardiology, Room 23,
Residential Tower; RC
Block, Okhla Road,
New Delhi - 110025
North
DELHI

Dr Ramaiah Keshava Fortis Hospitals Department of

Cardiology, No.14,
Cunningham Road,
Sheriffis Chamber,
Bangalore - 560052
Bangalore
KARNATAKA

Dr Sharad Chandra King Georges Medical Department of

University Cardiology, Lucknow -
226003
Lucknow
UTTAR PRADESH

Dr Anupama Hegde M.S. Ramaiah, Medical Department of

College & Hospital Cardiology, Clinical
Research Center, 1st
floor, New Bel Road,
Bangalore - 560054
Bangalore
KARNATAKA

Dr Naresh Kumar Goyal Max Super Speciality Department of

Hospital Cardiology, FC 50,
CAD block, Shallmar
Bagh, New Delhi -
110088
North
DELHI
Dr Viveka Kumar Max Super Speciality Department of
Hospital Cardiology, Saket, New
Delhi - 110017
North
DELHI

Dr Arun Garg Medanta-The Medicity Department of

Cardiology, Sector 38,
Gurgaon - 122001
North
DELHI

Dr Gurappa G Shetty Narayana Institute of Department of

Cardiac Sciences Cardiology, 258/A
Bommasandra
Industrial Area, Anekal
Taluka, Bangalore -
560099
Bangalore
KARNATAKA

Dr Ravindra B Gulati Ruby Hall Clinic Department of

Cardiology, Sasoon
Road, Pune - 411001
Pune
MAHARASHTRA

Dr Nakul Sinha Sahara India Medical

Institute

Dr Bhuwanesh Kandpal Sir Ganga Ram

Hospital

Details of Ethics Name of Committee Approval Status

Committee
Max Healthcare Ethics Not Applicable
Committee
B. M. Birla Heart Approved
Research Centre Ethics
Committee
 Ethics Committee, Not Applicable
Sahara Hospital
Institute Ethics Approved
Committee, SIR Ganga
Ram Hospital
Institutional Ethics Approved
Committee Office of
Research Cell - AIIMS
Institutional Ethics Approved
Committee, Poona
Medical Research
Foundation

Institutional review Approved

board of Asian Heart
Institute
Institutional, Ethical Approved
Review Board, M. S.
Ramaiah Medical
College and Hospital

Institutional, Ethics Approved

Committee, CARE
Hospital
Institutional, Fortis Approved
Hospitals Ethics
Committee
Max Healthcare Ethics Not Applicable
Committee
Medanta Independent Not Applicable
Ethics Committee
Narayana Hrudayalaya Approved
Medical Ethics
Committee
The Independent Ethics Not Applicable
Committee

Regulatory Clearance Status

Status from DCGI Approved/Obtained

Health Condition / Health Type

Problems Studied Patients

Type
 Intervention / Type
Comparator Agent Intervention

Comparator Agent

Inclusion Criteria
Age From
Age To
Gender
Details

Exclusion Criteria
Details

Method of Generating Not Applicable

Random Sequence
Method of Centralized
Concealment
Blinding/Masking Open Label
Primary Outcome Outcome
 The primary outcome is to measure the reversal
of anticoagulant effect of dabigatran based on
central laboratory determination of dTT or ECT.

Secondary Outcome Outcome

- Mortality
- Number of days hospitalized in ICU
For ICH patients with serial CT scans, an
estimate of blood volume
- Fro Gp. A patients: Use of blood products after
administration of study drug (includes FFP,
packed
RBCs, platelets, volume expanders, tranexamic
acid, cryoprecipitate, Factor
VIIa and any other hemostatic agents. Use of
dialysis, change from baseline in haematocrit,
Hb.
Gp. B patients: Occurrence of bleeding. Bleeding
will be categorized by the treating clinician.

Target Sample Size Total Sample Size=250

Sample Size from India=10
Final Enrollment numbers achieved (Total)=Applicable only for Completed/Termi
Final Enrollment numbers achieved (India)=Applicable only for Completed/Termi

Phase of Trial Phase 3

Date of First 28/01/2015
Enrollment (India)
Date of First 30/07/2014
Enrollment (Global)
Estimated Duration of Years=3
Trial Months=9
Days=3

Recruitment Status of Closed to Recruitment of Participants

Trial (Global)
Recruitment Status of Closed to Recruitment of Participants
Trial (India)
Publication Details Not applicable as of now. If an interim report is generated for regulatory approval, th
be published.
Brief Summary Till date, management of serious bleeding in patients on dabigatran, including life-th
fatal bleeding, is limited to supportive care, administration of blood or blood product
possibility of dialysis to remove the drug. Until now, there has been no treatment tha
reverses the pharmacological effect of dabigatran. Such an antidote has the potenti
management of patients with dabigatran-associated bleeding. Bleeding may be redu
abolished.
A small fraction of patients who are treated with dabigatran and who have co-morbid
emergency surgery or procedures related to those co-morbidities, e.g. cardiac cathe
patient with acute coronary syndrome, surgery for a patient with acute appendicitis o
who is not currently bleeding. In such cases an immediate reversal of the anticoagu
 Till date, management of serious bleeding in patients on dabigatran, including life-th
fatal bleeding, is limited to supportive care, administration of blood or blood product
possibility of dialysis to remove the drug. Until now, there has been no treatment tha
reverses the pharmacological effect of dabigatran. Such an antidote has the potenti
management of patients with dabigatran-associated bleeding. Bleeding may be redu
abolished.
A small fraction of patients who are treated with dabigatran and who have co-morbid
emergency surgery or procedures related to those co-morbidities, e.g. cardiac cathe
patient with acute coronary syndrome, surgery for a patient with acute appendicitis o
who is not currently bleeding. In such cases an immediate reversal of the anticoagu
dabigatran is desirable to minimize the risk of excessive bleeding associated with th
procedure.
The reversal of the anticoagulant effects of dabigatran by idarucizumab, has been d
volunteers, but the effect of the antidote in bleeding patients or those requiring eme
surgery/procedures has not yet been shown. This trial is designed to demonstrate th
the dabigatran anticoagulant effect by idarucizumab and to support the approval of

Application (BLA).

There is no hypothesis testing for this trial.

 Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 05:0

CTRI Number CTRI/2015/08/006133 [Registered on: 21/08/2015] - Trial Registered Retrospectiv

Last Modified On 18/02/2021
Post Graduate Thesis Yes
Type of Trial Observational
Type of Study Cross Sectional Study
Study Design Single Arm Study
Public Title of Study Does a Supreme laryngeal mask fit an Indian patient correctly ?
Scientific Title of Does a Supreme Laryngeal Mask Airway (SLMA) selected on basis of patients weig
Study optimal fit in Indian population?
Secondary IDs if Any Secondary ID
NIL

Details of Principal
Investigator or overall Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Scientific Name
Query)
Designation
Affiliation
Address

Phone
Fax
Email

Details Contact
Person (Public Query) Name
 Name
Designation
Affiliation
Address

Phone

Fax
Email

Source of Monetary or
Material Support > Tata Memorial Hospital E Borges Marg Parel Mumbai 400012
Primary Sponsor
Name
Address
Type of Sponsor

Details of Secondary Name

Sponsor NIL
Countries of List of Countries
Recruitment India
Sites of Study Name of Principal Name of Site
Investigator
Dr Aparna Chatterjee Tata Memorial Centre

Details of Ethics Name of Committee Approval Status

Committee
InstitutionalEthicsCom Approved
mittee

Status
 Regulatory Clearance Status
Status from DCGI Not Applicable
Health Condition / Health Type
Problems Studied Patients

Patients

Intervention / Type
Comparator Agent
Inclusion Criteria
Age From
Age To
Gender
Details

Exclusion Criteria
Details

Method of Generating Not Applicable

Random Sequence
Method of Not Applicable
Concealment
Blinding/Masking Open Label
Primary Outcome Outcome
Fit of a SLMA in Indian patients when selected
on weight criteria

Secondary Outcome Outcome

sorethroat, throat pain and dysphagia

Target Sample Size Total Sample Size=200

Sample Size from India=200
Final Enrollment numbers achieved (Total)=0
Final Enrollment numbers achieved (India)=218

Phase of Trial N/A

Date of First 06/06/2014
 06/06/2014
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=0
Trial Months=6
Days=0

Recruitment Status of Not Applicable

Trial (Global)
Recruitment Status of Completed
Trial (India)
Publication Details Chatterjee A, Yadav A. Does a supreme laryngeal mask airway (SLMA) selected on
patient’s weight provide an optimal fit in Indian population? J Anesth Crit Care Open
2018;10(6):242?245. DOI: 10.15406/jaccoa.2018.10.00396

Brief Summary The Laryngeal mask airway, a supraglottic device has replaced the endotracheal tu
preferred airway in several routine surgeries. The Supreme laryngeal mas
second generationLMA is one of the more recent development
LMA family introduced in 2007. It is one of the most advanced
airways yet. The SLMA is a single use, latex free device with a
curve to facilitate ease of insertion, a built-in bite block and a fix
help secure the device. The cross section is oval which improv
stability of the device once inserted, minimizing dislodgements.
has a drain tube to allow gastric aspiration and a high volume –
pressure cuff which generates a higher seal pressure both aim
minimize the risk of pulmonary aspiration of gastric contents.Te
performed to confirm the correct positioning, i.e separation of th
alimentary track and the airway include;
1. The “Bubble Test”
The gastric or the drain tube is sealed with lubricant (lignocaine
positive pressure ventilation, there must be no bubbles appeari
gastric tube opening. Bubbles would indicate an incomplete se
the airway from the esophagus with the risk of gastric inflation.

of Supreme LMA sitting in the upper esophagus, an unob

tube would include an air column. Pressing on the sternal
esophagus would move this air column and produce bubbles
 opening of the gastric tube.

2. Gastric tube

A gastric suction tube should be inserted through the gastr

LMA. The tube should pass without problems and the sto
suctioned.

Optimal size selection is required for safe and effective use of SLMA.It is
available in sizes ranging from 1 to 5 with the size selection recommended
on weight-basis(size 3,30-50 kg,size 4,50-70kg,size5,70-100kg with
maximum cuff volume recommended-30ml/45ml/45ml respectively and the
largest OG tube that can be passed for all 3 being-14 Fr).In the West, a
no. 4 SLMA is routinely used for females and SLMA no.5 for males in
general.The average weight in Indian population is 55Kg, and when
selected on the basis of weight, most Indian females require a size 3
SLMA and males a size 4. LMA Supreme delivers measured
oropharyngeal leak pressures upto 37cm H2O.It is also very important not
to exceed the maximum inflation volume recommended to maintain a
seal,else the use of a size larger should be considered

Using too small a mask and over inflating the cuff will decrease cuff
compliance and may result in a poor fit within the pharyngeal space.For
LMA Supreme size selection we use the same weight based criteria as is
in the West but there are a lot of differences in
stature,facialfeatures,airwayanatomy,average weight and average height
in Indian population as compared to western world .There is no Indian
study to evaluate the fit of LMA chosen according to weight based
criteria as per western standards.The aim of current study will be to
determine whether LMA size selection as suggested based on patient’s
weight (according to western standards) provides an appropriate fit or
notin an Indian population?It is an observational study,to identify whether,
the fit of LMA Supreme in Indian population based on weight criteria is
optimal or not,by studying various parameters.
 MATERIAL & METHODS

After Institutional Review Board approval, and an informed consent, adult

patients undergoing surgeries (<3 hours duration) at Tata Memorial
Hospital under general anaesthesia with a SLMA to provide the airwayand
eligible as per inclusion criteria will be included in the studyduring a 6
month period .A well informed consent will be obtained from them
preoperatively after clearing all their doubts and answering their queries.
All eligible and consenting patients will be enrolled in the study over a 6
month period.
The general anaesthesia provided and the size of the SLMA to be inserted
will be decided by the operating room anaesthetist on weight basis.
Correct placement should produce a leak-free seal against the glottis with
the tip at the upper esophageal sphincter. The bite block of the device
should be between the teeth and fixation tab should be 1.5 cm to 2.5 cm
from the upper lip. Malposition results in a poor airway seal and an audible
and immediately detectable leak of delivered gases through the drain tube,
minimizing gastric insufflation. The following information will be recorded in
the case record form; patient’s registration number, age, sex, weight in
kilograms, retrognathia if present , mouth opening in centimetres,
Mallampatti classification, jaw slide, whether difficult airway was
anticipated. Size of SLMA selected on weight basis, ease of placement of
the device, the number of attempts at insertion, the level of training of the
person who inserted the device and whether inserted partially inflated or
fully deflated,will also be recorded.A failed insertion is defined as a failed
passage, a persistent air leak, malposition or ineffective ventilation.The
operating theatre anaesthetist’s opinion on whether they considered the fit
of the SLMA acceptable for perioperative use will be noted.The need to
reposition or change to a different size SLMA or to a classic LMA or ETT
will be recorded. The need for further manipulations required
intra-operatively will also be noted.The position of the SLMA bite block i.e;
whether in between the incisors, ahead or behind the incisors will be
recorded. The distance of the fixation tab from the upper lip will also be
documented. Also’ Bubble test’ will be performed, a water soluble jelly
will be put in the drain tube if bubbles seen, it signifies incomplete
separation of esophagus from airway. The discrepancy between the set
and the expired tidal volume, the pattern of the Capnograph(square wave,
obstructed pattern or none)and the peak airway pressures will also be
recorded. A well lubricated 7 no. red rubber tube corresponding to a 14 Fr
gastric tube, will be passed through the drain tube and liquid gastric
contents aspirated to confirm correct placement. The placement/fit of the
SLMA will be considered to be Optimal if; the fixation tab is between
1.5-2.5 cm from upper lip, the bit is between the teeth, no audible or
measurable leak of tidal ventilation, gastric tube can be inserted easily
through the drain tube with a square wave pattern of the CO 2 waveform
and peak pressures are within normal limits . If any one or more of the
above mentioned criteria are absent but tidal ventilation is acceptable, the
SLMA placement will be considered to be acceptable.The fit will be
considered poor if any one or more of the above mentioned criteria are not
met along with an audible and measurable leak of tidal ventilation.
Oropharyngeal leak pressure or a glottic seal pressure is an indicator of
the degree of airway protection and an OLP of 60 cmH2Ois recommended
for a SLMA. The OLP or seal pressure will be determined by closing the
expiratory valve of the circle system at a fixed gas flow of 3litres/minute
and noting the airway pressure at which the gas leak occurred and
recorded. The volume of air required to inflate the cuff will be recorded.
High intracuff pressures are known to reduce pharyngeal mucosal
perfusion, cause nerve compression and neuropraxia, leading to
postoperative pharyngolaryngeal adverse effects such as sore throat,
dysphasia, dysphonia and nerve injury. Sore throat is the constant pain or
discomfort in the throat independent of swallowing. Dysphonia is defined
as “difficulty in speaking”; dysphagia as “difficulty or pain caused by
swallowing”.The intracuff pressures will be recorded using a handheld
manometer.After removal of the SLMA presence of any blood on the
device will be recorded. Postoperative complications such as, sore throat,
dysphonia and dysphagia will be documented.
 PDF of Trial
CTRI Website URL - http://ctri.nic.in

:- Sun, 08 Jan 2023 04:59:42 GMT)

rial Registered Prospectively

?controlled, Multi?centre Trial on Infections

amase (ESBL and MBL) producing Gram

?controlled, Multi?centre Trial to Compare the

ctam+ EDTA) with Meropenem in Infections
Gram Negative Bacteria
Identifier
Protocol Number

Details of Principal Investigator

Dr Sumit Saxena
Overall Trial Coordinator
Manager, Deptt of Clinical Research Venus Remedies Ltd
Venus Remedies Limited Hill Top Industrial Area, EPIP Phase1 Ex
Jharmajri Village Bhatoli Kalan, Baddi (Dist Solan), Himachal
Pradesh India Corporate office: Venus Remedies Limited Plot No
51-52 Industrial Area Phase1 Panchkula (Haryana) 134113, India
Solan HIMACHAL PRADESH 173205 India
Solan
HIMACHAL PRADESH
173205
India

01795302021
01795271272
manager1.crd@vmrcindia.com
Details Contact Person (Scientific Query)
Dr Mohd Amin Mir
Deputy General Manager
Venus Remedies Limited
 Venus Remedies Limited Hill Top Industrial Area, EPIP Phase1 Ex
Jharmajri Village Bhatoli Kalan, Baddi (Dist Solan), Himachal
Pradesh 173205 India Venus Remedies Limited Plot No 51-52
Industrial Area Phase1 Panchkula (Haryana) 134113, India
Solan
HIMACHAL PRADESH
173205
India

01795302051
01795271272
medcom@vmrcindia.com
Details Contact Person (Public Query)
Dr Mohd Amin Mir
Deputy General Manager

PDF of Trial
CTRI Website URL - http://ctri.nic.in

Venus Remedies Limited

Venus Remedies Limited Hill Top Industrial Area, EPIP Phase1 Ex
Jharmajri Village Bhatoli Kalan, Baddi (Dist Solan), Himachal
Pradesh 173205 India Venus Remedies Limited Plot No 51-52
Industrial Area Phase1 Panchkula (Haryana) 134113, India
Solan
HIMACHAL PRADESH
173205
India

01795302051
01795271272
medcom@vmrcindia.com
Source of Monetary or Material Support
ear Jharmajri, E.P.I.P., Phase-I, (Extention)
de: 173 205, India

Primary Sponsor Details

Venus Remedies Limited
Plot No-51-52 Industrial Area Phase-1 Panchkula -134113 Haryana
(India)
Pharmaceutical industry-Indian
Address
NIL
Name of Site Site Address Phone/Fax/Email

Ajanta Hospital & 765, ABC Complex, 9936507362

research Centre Kanpur Road, 0522-4101017
Alambagh, drdeepakdewan@rediff
Lucknow-226005, UP, mail.com
India
Lucknow
UTTAR PRADESH

All india Institute of Deptt. of urology, 09899390027

Medical Sciencies AIIMS, New Delhi premnathdogra@gmail.
New Delhi com
DELHI

CMC Hospital CMC Hospital 9814034185

Ludhiana, Punjab, India kjmammen@gmail.com
-141008
Ludhiana
PUNJAB

Deenanath Mangeshkar Deenanath Mangeshkar 91-9823266762

Hospital and Research Hospital and Research phadke.pratibha@gmail
Centre Centre, Erandwane, .com
Pune - 411004,
Maharashtra, India.
Pune
MAHARASHTRA

Dr. Ram Manohar Lohia Dr. Ram Manohar Lohia 9810005182

Hospital & PGIMER Hospital & PGIMER, drsoodr@gmail.com
Room No. 31, Ground
Floor, OPD Block, Baba
Kharag Singh Marg,

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CTRI Website URL - http://ctri.nic.in

New Delhi – 110001,

India, Room No. 31,
New Delhi
DELHI
Government Medical 9427478093
College, New Civil mahendraz_patel@yah
Hospital, Outside oo.com
Majuragate,
Surat-395001, Gujarat,
India
Surat
GUJARAT
Department of 9822234566
Medicine, Government drmilind72@gmail.com
Medical College,
Medical Chowke,
Nagpur-4400003,
Maharashtra, India
Nagpur
MAHARASHTRA

Hi-Tech Medical 09438554039

College & Hospital, drsarat2010@rediffmail.
Pandra, Rasulgarh,Bhu com
baneswar-751010,
Odisha, India
Nayagarh
ORISSA

KLE Dr. Prabhakar 9341101268

Kore Hospital & maddy2380@gmail.co
Research Centre, m
Nehru Nagar, Balagavi,
Karnataka
Belgaum
KARNATAKA

Associate Professor 09412731835

Department of drshameem123@gmail.
Tuberculosis and chest com
diseases, J.L.N.
Medical College,
Aligarh Muslim
university, Aligarh (U.P)
202002
Aligarh
UTTAR PRADESH

KIMS Hospital, 09845291587

Banglore KIMS kimshuliraj@gmail.com
Hospital, Banglore
Professor & HOD,
Department of
Pulmonology Medicine,
KIMS Hospital &
Research Center,
K.R.Road, V.V.Puram,
Bangalore KA, 560004
Bangalore
KARNATAKA

King Georges Medical 9554952051

University Lucknow, rahuljanaksinha@aol.co
Uttar Pradesh, India-

page 3 / 12

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226003 m
Lucknow
UTTAR PRADESH
314/30, Mirza Mandi, 9415233540
Chowk, Lucknow - 0522-4016051
226003, UP, India mauryadr@gmail.com
Lucknow
UTTAR PRADESH

Muljibhai Patel 9824360818

Urological Hospital sishirgang@hotmail.co
(Kidney Hospital),Dr. m
Virendra Desai Road,
Nadiad 387001, Gujarat
(India)
Kheda
GUJARAT

Om Surgical Center & 9839061967

Maternity Home omresearchcenter@gm
SA-17/3, P-4, Sri ail.com
Krishna Nagar,
Paharia,Ghazipur
Road, Varanasi
-221007
Varanasi
UTTAR PRADESH

C-1, Shushant Lok-1 9818244167

Sector -92 Gurgaon, neeraj.shubhra@gmail.
Haryana -122002 com
Gurgaon
HARYANA

Peerless Hospitax 9830006644

Hospital And Research ajoysarkar29@gmail.co
Center Limited m
360,Panchasayar,
Kolkata.
Kolkata
WEST BENGAL

Department of Urology 09417532955

Postgraduate Institute ravismi2003@yahoo.co
of Medical Education & m
Research, Sector-12,
Chandigarh,Pin- 160
012, India
Chandigarh
CHANDIGARH

Prime Hospital, 9848883444

MIG-113 & 114, Road drnagaraj.b@gmail.com
No-1, KPHB Colony,
Kukatpally,
Hyderabad-500072
Hyderabad
ANDHRA PRADESH
Ratandeep Hospital 9839104065
and Research Centre, ratandeeph@gmail.com
1-6, Besides Rave Moti,
Kakadeo, Kanpur –
208025 , India
Kanpur Nagar
UTTAR PRADESH

page 4 / 12

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S.P. Medical College, S.P. Medical College, 01512202131

Bikaner- Bikaner- 334003, drrpagrawal@yahoo.co
Rajasthan, India m
Bikaner
RAJASTHAN

Samved Hospital, Samved Hospital, 2nd 9824047750

floor, on stadium circle drjanakddesai@gmail.c
to commerce six roads, om
Navrangpura,
Ahmedabad-380009,
Gujarat, India
Ahmadabad
GUJARAT

Sapthagiri Institute of Sapthagiri Institute of 9986143260

Medical Sciences and Medical Sciences and Manju2586_suri@rediff
Research Centre, Research Centre, #15, mail.com
Chikkasandra,Hesarag
atta Main Road,
Bangalore-560
090,Karnataka,India
Bangalore
KARNATAKA

Sher-I-Kashmir Institute SKIMS, Soura, 09419004822

of Medical Sciences Srinagar, Jammu and parvaizk@gmail.com
Kashmir 190011
Srinagar
JAMMU & KASHMIR

Sir Ganga Ram Sir Ganga Ram 9810233670

Hospital Hospital, Rajinder drsudhirchadha@gmail.
Nagar, New com
Delhi-110060, India
New Delhi
DELHI
SMS Medical College & Institute of Respiratory 9829017619
Hospital Disease,SMS Medical drnkhippal@rediffmail.c
College & om
Hospital,Subhash nagar
shopping centre,
Shastri nagar,Jaipur-
302016, Rajasthan,
India
Jaipur
RAJASTHAN

Sudbhawana Hospital B-31/80, 23B, Bhogabir, 9839056553

Lanka, Varanasi, drakumar221@gmail.co
-221005 m
Varanasi
UTTAR PRADESH

Trimurti Hospital Trimurti Hospital Gilat 9415221720

Bazar,Varanasi-221005 trimurticrvns@gmail.co
Varanasi m
UTTAR PRADESH

Approval Status Date of Approval Is Independent Ethics

Committee?
Approved 06/10/2013 No

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CTRI Website URL - http://ctri.nic.in

15/10/2013 No

18/10/2013 No

20/11/2013 No

31/10/2013 No
01/11/2013 No

31/12/2013 No

27/12/2013 No

25/01/2014 No

04/01/2014 No

12/12/2013 No

13/11/2013 No
17/12/2013 No

22/02/2015 No

29/03/2015 No

28/02/2015 No

04/01/2016 No

31/12/2015 No

18/02/2016 No

05/04/2016 No

page 6 / 12

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Approved 24/06/2016 No

Approved 15/07/2016 No

Approved 09/09/2016 No

Approved 13/12/2015 No
Approved 05/06/2015 No

Approved 30/05/2014 No

Approved 12/03/2015 No

Approved 28/12/2015 No

Date
19/12/2014
Condition
pneumonia (either moderate to severe CAP or
mild to moderate or severe HAP or HCAP) and
suspected cUTI
Urinary tract infection, site notspecified
Name Details
CSE 1034 Duration of treatment is 23 to 32
days (treatment period+ TOC +
follow up)depending upon
severity of infection for each
patient. Route of administration:
IV Dose: 1500 mg

Meropenem Duration of treatment is 23 to 32

days (treatment period+ TOC +
follow up)depending upon
severity of infection for each
patient. Route of administration:
IV Dose: 1000 mg

Inclusion Criteria
18.00 Year(s)
99.00 Year(s)
Both
 Inclusion Criteria:<br/> 1.Subjects willing to provide informed
consent and who are willing to or likely to comply with all study
requirements.<br/> 2. Subjects of either gender must have age
above 18 years<br/> 3.Subjects with diagnosis of pneumonia (either
moderate to severe CAP or mild to moderate or severe HAP or
HCAP)<br/> - On the basis of clinical signs and symptoms of LRTI
suggestive of pneumonia<br/> - Subjects with clinical findings and/or
chest x?ray suggestive of pneumonia requiring hospitalization and
need treatment with IV antimicrobials.<br/> - CAP moderate and
severe cases / mild to moderate or severe HAP cases/HCAP
cases<br/> - Sputum or Bronchoalveolar lavage (BAL) culture results

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confirm bacterial pneumonia caused by ? ? Lactamase (ESBL or

MBL) ? producing Gram?negative Bacteria or <br/> 4. Subjects with
suspected cUTI<br/> - On the basis of clinical signs and
symptoms<br/> - Urine culture results confirm bacterial urinary tract
infection caused by ? ?lactamase producing gram?negative bacteria
requiring intravenous therapy<br/> - Patients with indwelling
catheters should have the catheter removed or replaced if removal is
not clinically acceptable, before or as soon as possible, but not
longer than 12 hour, after randomization<br/> - Obstructive uropathy,
where the obstruction is likely to be relieved by stent or nephrostomy
tube no later than 24 hours after randomization<br/> 5. Subjects
having received antibiotics for urinary tract infection or pneumonia
only if the duration of therapy was ? 24 hours within 72 hour of
enrolment.<br/> 6. Subjects having received prior antibiotics and not
showing any clinically significant improvement irrespective of
duration of therapy.<br/> 7. Females of childbearing potential require
a negative urine pregnancy test and must agree to abstinence or to
use an effective method of contraception.

Exclusion Criteria
 Exclusion Criteria:
1. Subjects with clinically significant cardiovascular, renal, hepatic,
gastrointestinal conditions, neurological, psychiatric, respiratory,
other severely immunocompromised,
haematological or malignant disease and other condition which may
interfere with the assessment. History of uncontrolled diabetes
mellitus, HIV and hepatitis-B will be excluded.
2. Subjects with history of resistance to any of the investigational
drugs will be excluded from the study
3. Subjects with history of hypersensitivity, allergic response or any
contra-indications to penicillin, cephalosporin or carbapenem groups
of drugs.
4. Subjects with creatinine clearance below 30 mL/min
5. Subjects having abnormal laboratory parameters which in the
opinion of PI are clinically significant enough to pose any undue
safety concern for the patient or can interfere with
patients assessment
6. In cUTI cases:
- Perinephritic abscess or renal corticomedullary abscess, polycystic
kidney disease, only one functional kidney, chronic vesicoureteral
reflux
- Uncomplicated UTI
- Previous or planned renal transplantation or cystectomy
- Urinary tract surgery within 7 days prior to randomization
or urinary tract surgery planned during the study period (except
surgery to relieve obstruction, to place a stent or nephrostomy)
7. Subjects with a Body Mass Index greater or equal to 35 kg/m2
8. Pregnant or lactating women
9. Participation in any clinical study within the previous 6 month

Outcome Timepoints
Test of Cure Visit (i.e. 10 days from end of
treatment)

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Outcome Timepoints
EOT, TOC and LFU Visits

EOT, TOC and LFU visits

ummy, Active?controlled, Multi?centre Trial

triaxone + Sulbactam + EDTA) with
SBL and MBL) producing Gram Negative

34 compared to meropenem in patients

nity acquired pneumonia, hospital acquired
d complicated urinary tract infections caused

producing gram negative bacterial

cal efficacy evaluable (CEE) and the

 ummy, Active?controlled, Multi?centre Trial
triaxone + Sulbactam + EDTA) with
SBL and MBL) producing Gram Negative

34 compared to meropenem in patients

nity acquired pneumonia, hospital acquired
d complicated urinary tract infections caused

producing gram negative bacterial

cal efficacy evaluable (CEE) and the

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ng incidence of adverse events and serious

es hematology, clinical biochemistry, vitals and clinical

this study have been presented separately to

d EMA. The FDA co-primary endpoints are defined

on (or return to premorbid state) of all

k pain / suprapubic pain) at the TOC visit in the

microbiological eradication and symptomatic

UTI-specific symptoms (frequency/urgency/ flank pain

r-patient microbiological response at the TOC visit in

-patient microbiological response at the EOT, TOC,

on (or return to premorbid state) of all

ank pain / suprapubic pain) at the EOT, TOC and LFU

crobiological response at the EOT, TOC, and LFU visits

r-determined clinical cure at the EOT, TOC, and LFU

stigator clinical response assessment and/ separately,

e TOC visit for patients infected with a

solution (as defined in the co-primary variables) at

sistant pathogen in the extended ME analysis set
udy therapy in patients in the mMITT, ME, extended

ys of treatment till TOC visit.

uality of life using MOS–SF–36 scale.

sus the comparator will be analyzed (The cost of
ventions done for source control (e.g., chest

verse event (TEAE)

of study drug therapy
study drug therapy

symptoms of the index infection have improved or

riteria below will be considered as failure:

istence or progression of most or all pre-therapy signs

tion
for the EOT visit)

y reason, including:
undertaken such that a determination of clinical

48 hours prior to randomization and compared with the

culture from the TOC or LFU visit shows that the

page 10 / 12

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CTRI Website URL - http://ctri.nic.in

ates <104 CFU/mL of the original pathogen, and the

remic at Screening, the bacteremia has

valuation of efficacy, for any reason including:

ent is not undertaken such that no urine culture was
reted for any reason) at either the EOT, the TOC, or

cation or persistence

at EOT or TOC

/mL of a pathogen other than a baseline pathogen

dy therapy along with worsening signs and symptoms
dy therapy of a new pathogen.
al pathogen found at Screening at a level of ?105
f any pathogen was isolated from a site distant to
erapy had been completed, this will also be

on and a positive study entry urine culture defined as

h the drugs.
fied in the study entry culture regardless of colony
en, or a bacterial species typically not expected to

s
include all patients meeting the following criteria:

with ?80% of the scheduled drug administered over the

rapy <48 hours before discontinuing treatment due to

fect the assessment of efficacy

e EOT or TOC visits, respectively, with a microbiological
e culture
otential activity against the baseline pathogen
seline culture and the EOT or TOC culture,
erapy). Study therapy is defined as blinded IV
erapy taken for the treatment of targeted infection by

48 hours before the start of treatment with IV study

o both IV study therapies

ts meeting the following criteria:

LFU visit, with a microbiological response other than

visit, defined as any events that could impact the

example of confounding event is a deviation in

h potential activity against the baseline pathogen since

herapy taken for the treatment of targeted infection

and LFU visits includes patients meeting the

ption that baseline pathogens need not be susceptible

page 11 / 12

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CTRI Website URL - http://ctri.nic.in
 includes all patients meeting the following criteria:

with ?80% of the scheduled drug administered over the

rapy <48 hours before discontinuing treatment due to

fect the assessment of efficacy

linical cure or failure (and not indeterminate) at the EOT

ential activity against the baseline pathogen between

ture, respectively (other than
s defined as blinded IV study drug. This does not
targeted infection by patients who were

d ?48 hours before the start of treatment with IV study

ts meeting the following criteria:

ical cure or failure (and not indeterminate) at the at

fect the assessment of efficacy

h potential activity against the baseline pathogen since
herapy taken for the treatment of targeted infection

rue response of > 96% for each co-primary endpoint

andomized patients, a sample size of 228 patients
eriority of CSE-1034 versus Meropenem was
sided 95%confidence interval around the
) or greater than 10% (FDA and EMA)
ensured >85% power for a 10%
non-inferiority margin. The sponsor will conclude
rresponding to a 97.5% 1-sided lower bound) is
bles; however, non-inferiority may be assessed
regulatory requirement. A sensitivity analysis will also
s for both the EOT and TOC visits and also
-primary variable, i.e., per patient microbiological
urn to premorbid state) of all UTI-specific symptoms
nk pain) at TOC as part of the secondary efficacy
set. The analysis for the co-primary outcome variables
ssment, their components (as specified
ubgroups. The subgroups to be analyzed will
aseline pathogens, age, and sex. Synthesis of
n is appropriate for assessment of non-inferiority in
ns in the regulatory requirements for non-inferiority
trial has been sized to provide 85% power for a
gions (therefore providing >98% power to assess
 page 12 / 12

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:- Sun, 08 Jan 2023 04:59:56 GMT)

rial Registered Prospectively

ry tract infection and pyelonephritis

fozopran Hydrochloride and Inj. Cefpirome
ct Infections and Pyelonephritis - An

Identifier
Protocol Number
Details of Principal Investigator
Kanchan Tyagi
Project Leader
Ranbaxy Laboratories Ltd
Plot No 77B Sector 18 IFFCO Road
Gurgaon
HARYANA
122015
India

1244194218
1244107000
kanchan.tyagi@ranbaxy.com
Details Contact Person (Scientific Query)
Shilpa Sharma
 Shilpa Sharma
Medical Monitor
Ranbaxy Laboratories Ltd
Plot No 77B Sector 18 IFFCO Road
Gurgaon
HARYANA
122015
India

1244194225
1244107000
shilpa.sharma@ranbaxy.com
Details Contact Person (Public Query)
Kanchan Tyagi
Project Leader
Ranbaxy Laboratories Ltd
Plot No 77B Sector 18 IFFCO Road
Gurgaon
HARYANA
122015
India

1244194218
1244107000
kanchan.tyagi@ranbaxy.com

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Source of Monetary or Material Support

IFFCO Road Gurgaon - 122015 , Haryana
Primary Sponsor Details
Ranbaxy Laboratories Ltd
Plot No. 77 B, Sector 18, IFFCO Road Gurgaon - 122015 , Haryana
Pharmaceutical industry-Global
Address
NIL

Name of Site Site Address Phone/Fax/Email

ACE Hospital and 32/2A Behind 09881256992
Research Centre AMAI Mehendale Garage, researchamai@gmail.c
Charitable Trust Erandwane Pune om
411004
Pune
MAHARASHTRA

Apollo Gleneagles 58 Canal Circular Road 09830339217

Hospital Kolkata vmahendra@gmail.
Kolkata
WEST BENGAL

Bhatia Hospital Medical Associate Prof and 9322589110

Research Society Consultant Physician drpratit@gmail.com
Bhatia Hospital Medical
Research Society
Tardeo Road Grant
Road Mumbai 400007
Mumbai
MAHARASHTRA

Department of 244 AJC Bose Road, 9433254601

Nephrology IPGME and kolkata lahiri.arpi@gmail.com
R SSKM Hospital Kolkata
WEST BENGAL

Department of surgery Dept of Surgery KING 09415028046

KING GEORGES GEORGES MEDICAL pahwakgmu@yahoo.co
MEDICAL UNIVERSITY Lucknow .in
UNIVERSITY Uttar Pradesh
Lucknow
UTTAR PRADESH

Dr Sharadchandra Supe Heart and 09892706382

Prasad Diabetes Hospital and drsharadprasad@gmail.
research Centre com
Opposite Adhar Ashram
Near Rungta School
Gharpure Ghat Ashok
Stambh Nashik
Nashik
MAHARASHTRA

Dr Suresh S Dubhashi Vintage Hospital and 08326711541

Medical research cromgoa@gmail.com
Centre Pvt Ltd Caculo
Enclave St Inez Panaji
Goa
South Goa

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 GOA
Fortis Escorts Hospital Jawahar Lal Nehru 09829696995
Marg Malviya Nagar drjainalok@gmail.com
Jaipur
Jaipur
RAJASTHAN

Medilink Hospital and Opposite Someshwara 07926760646

Research Center Jain Temple 132 Ft medilinkresearchcentre
Ring Road Satellite @yahoo.com
Ahmedabad
Ahmadabad
GUJARAT

Muljibhai Patel Muljibhai Patel 9426422002

Urological Hospital Urological Hospital Dr 02682520248
Virendra Desai Road rbsabnis@gmail.com
Nadiad 387001
Kheda
GUJARAT

MV Hospital and MV Hospital and 9336077839

Research Centre, Research Centre sandeepkumar.gupta@
Lucknow 314/30 Mirza Mandi, rediffmail.com
Chowk, Lucknow
Lucknow
UTTAR PRADESH

Orange City Hospital & Orange City Hospital 09766321910

Research Institute and Research Institute, drsandeepsd@gmail.co
19, pande layout, veer m
sawarkar square,
Nagpur – 440015
Nagpur
MAHARASHTRA

Sanjay Gandhi Post Sanjay Gandhi Post 9415410130

Graduate Instituite of Graduate Instituite of rkapoor@sgpgi.ac.in
Medical Sciences, Medical Sciences, Rai
Lucknow Bareilly Road, Lucknow
Lucknow
UTTAR PRADESH

SMS Medical College Department of Urology 09828015854

and Hospital SMS Medical College spriyadarshi64@gmail.c
and Hospital om
Jaipur
RAJASTHAN

St Theresa Hospital Erragadda Sanath 01416450553

Nagar Hyderabad vcmohan2001@yahoo.
500018 Andhra co.uk
Pradesh
Hyderabad
ANDHRA PRADESH

Approval Status Date of Approval Is Independent Ethics

Committee?
Approved 22/01/2013 No
Approved 04/07/2013 No

Approved 11/06/2013 No

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Approved 26/07/2013 No

Approved 05/10/2013 No

Approved 14/05/2013 No

Approved 28/08/2013 No

Approved 02/07/2013 No

Approved 13/12/2013 No

Approved 14/07/2013 No

Approved 05/01/2013 No

Approved 13/08/2013 No
Approved 13/07/2013 No

Approved 25/09/2013 No

Approved 10/11/2013 No

Date
12/12/2012
Condition
Complicated urinary tract infection and
Pyelonephritis

Name Details
Cefozopran injection 1 gm After administration of at least
14 doses of Inj. Cefozopran 1

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gm, subjects may be switched

to oral antibiotic treatment with
Tab. Ciprofloxacin. Subjects
eligible for oral antibiotic therapy
will receive Tab. Ciprofloxacin
(500 mg, 12 hourly) to complete
the remaining days of the 10
day treatment period. The total
duration of study drug therapy
(i.v. study drug only or i.v. study
drug followed by oral
ciprofloxacin) will be 10 days.
However, depending upon the
clinical condition of the subject,
the duration of treatment can be
extended to 14 days at the
investigator’s discretion.
 Cefpirome injection 1 gm After administration of at least
14 doses of Inj. Cefpirome,
subjects may be switched to
oral antibiotic treatment with
Tab. Ciprofloxacin. Subjects
eligible for oral antibiotic therapy
will receive Tab. Ciprofloxacin
(500 mg, 12 hourly) to complete
the remaining days of the 10
day treatment period. The total
duration of study drug therapy
(i.v. study drug only or i.v. study
drug followed by oral
ciprofloxacin) will be 10 days.
However, depending upon the
clinical condition of the subject,
the duration of treatment can be
extended to 14 days at the
investigator’s discretion.

Inclusion Criteria
18.00 Year(s)
99.00 Year(s)
Both
1. Subjects of either sex, aged greater than or equal 18 years who
have given written informed consent to participate in the study.<br/>
<br/> 2.Subjects with diagnosis of complicated urinary tract infection
(cUTI) or pyelonephritis and requiring parenterally administered
antibacterial agent as per investigator’s judgment. The diagnosis of
cUTI or pyelonephritis will be made based on the below mentioned
criteria.<br/> <br/> A.Diagnosis of complicated urinary tract infection
will be based on the following criteria:<br/> <br/> (i)Presence of at
least one of the following signs and symptoms of urinary tract
infection:<br/> •Fever<br/> •Chills<br/> •Back Pain/Flank Pain<br/>
•Dysuria<br/> •Urgency<br/> •Frequency<br/> •Suprapubic
pain<br/> •Costovertebral angle tenderness<br/> <br/> (ii)Presence
of one or more of the following functional or anatomical abnormalities
of the urinary tract:<br/> •Indwelling catheter or recent
instrumentation.<br/> •More than 100 ml of residual urine after
voiding.<br/> •Neurogenic bladder.<br/> •Azotemia due to intrinsic
renal disease.<br/> •Obstructive uropathy due to nephrolithiasis or
fibrosis.<br/> •Urinary retention in men due to benign prostatic
hyperplasia or urethral strictures.<br/> <br/> (iii)Pyuria defined as

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greater than or equal to 10 leukocytes per cubic mm in freshly voided
urine<br/> <br/> (iv)A positive pre-treatment urine culture defined as
greater than or equal to 100000 colony forming units (CFU) per mL
of accepted uropathogen(s)[Urine culture specimens should be
obtained by sterile technique from clean catch midstream or urinary
catheter (in catheterized subjects). Foley catheter bag specimens
are not acceptable].<br/> <br/> B.Diagnosis of acute pyelonephritis
will be based on the following criteria:<br/> <br/> (i)Clinical signs and
symptoms of an ascending <br/> urinary tract infection manifested by
all three: fever (body temperature measured orally greater than 38
degree C or greater than 100.4 degree F, chills and flank pain/back
pain. In addition, subjects may also have costovertebral angle
tenderness, nausea, and vomiting.<br/> <br/> (ii)Pyuria defined as
greater than or equal to 10 leukocytes per cubic mm in freshly voided
urine<br/> <br/> (iii) A positive pre-treatment urine culture defined as
greater than or equal to 100000 colony forming units (CFU) per mL
of accepted uropathogen(s)[Urine culture specimens should be
obtained by sterile technique from clean catch midstream].<br/>
<br/> Note: Only those subjects will be included in whom the
indwelling catheter can be removed within 72 hours following first
dose of i.v therapy with cefozopran or cefpirome.<br/> Treatment
can be initiated when pyuria is confirmed and before the results of
colony count are available. However, when these results become
available the subject’s eligibility for continuation in the study shall be
reviewed. Subjects with colony counts less than 100000 colony
forming units (CFU) per mL and non evaluable isolates shall be
withdrawn from the study and may be treated at the discretion of the
investigator. Subjects with isolate(s) resistant to study medication
may be allowed to continue in the study at the discretion of the
investigator, only if they show clinical improvement. Subjects who, as
per investigator discretion, have persistence or worsening in the
signs and symptoms after 3 days of treatment, shall be withdrawn
from the study and treated at investigator’s discretion.<br/> <br/>
Enterobacteriaceae, Enterococci and Pseudomonas spp. will be
considered as evaluable pathogens and coagulase–negative
Staphylococci, non-group D Streptococci and multiple organisms
(greater than 2) as non–evaluable pathogens. In catherized subjects,
if two or more pathogens grow from the baseline urine culture, all
isolates will be considered contaminants (i.e., non-evaluable), unless
the same pathogen is also obtained from a simultaneously obtained
blood culture (two sets from different sites). If the same pathogen
grows in the urine at greater than or equal to 100000 CFU/mL and is
isolated from blood, then it will be considered as evaluable
pathogen.<br/> <br/> Note: Subjects diagnosed with acute
pyelonephritis will not be included in the study in case they have
history of or current evidence of underlying functional or anatomical
abnormality.

Exclusion Criteria
1.Subjects with history of hypersensitivity to Cefozopran, Cefpirome,
any other beta-lactam class of antibiotic or any of the excipients of
the study medication.
Excipients of Cefozopran are Sodium carbonate anhydrous and
Sodium chloride;
Excipients of Cefpirome are Sodium carbonate anhydrous.
2.Subjects who have failed to respond to Cefozopran /Cefpirome in
the past.
3.Subjects with a history of or currently suffering from allergic
bronchitis, bronchial asthma, rashes or hives.

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4.Subjects with history of vitamin K deficiency or conditions
predisposing to vitamin K deficiency such as poor oral intake, on
parenteral nutrition or malabsorption syndromes.
5.Subjects on chronic immunosuppressive therapy including use of
high dose corticosteroid (greater than or equal to 40 mg
prednisolone or equivalent) or with history of any severely
immunocompromising illness such as acquired immune deficiency
syndrome (AIDS).
6.Subjects with severe or intractable urinary tract infection expected
to require more than 14 days of treatment (e.g., perinephric
abscess/intra-renal abscess, complete obstruction of urinary tract or
subjects with known or suspected septicemia i.e., clinical
manifestations of sepsis or septic shock with or without detectable
organisms in blood culture) or requiring systemic antimicrobial
therapy in addition to the i.v. study drug.
7.Subjects with history of renal transplantation, ileal loops,
vesico-ureteral reflux, prostatitis, rapidly progressive or terminal
illness.
8.Subjects who have received treatment with a systemic
antimicrobial agent for greater than or equal to 24 hours within 72
hours prior to collection of urine for baseline urine culture.
9.Subjects with history of clinically significant diseases or disorders
(other than the disease in consideration) that in the opinion of the
investigator may (i) put the subject at risk because of participation in
the study (ii) interfere with the study evaluations or (iii) cause
concern regarding subject’s ability to participate in the study.
10.Pregnant or breast feeding women or women of child bearing
potential with a positive urine pregnancy test at screening or not
willing to use medically acceptable methods of contraception.
11.Subjects with history of substance abuse as per DSM IV criteria.
12.Subjects with creatinine clearance of less than or equal to 30 mL
per min (estimated from serum creatinine using the Cockcroft-Gault
formula) or requirement of peritoneal dialysis or hemodialysis.
13.Subjects with SGOT/AST or SGPT/ALT or alkaline phosphatase
or serum bilirubin greater than 2 times of upper limit of normal (ULN)
at screening or total leukocyte count less than 3500 per cubic mm.
14.Subjects who are unable or unwilling to comply with the study
procedures.
15.Subjects who have participated in another investigational study
within the last 3 months prior to entry in this study.
Outcome Timepoints
Test of Cure Assessment (7±2 days post
therapy)

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Outcome Timepoints
Test of Cure Assessment (7±2 days post
therapy)

ve study with an objective to compare

pran inj. 1 gm against Cefpirome, to be
ays (may be given up to 10 days) for
on and Pyelonephritis. The study
hical locations of India. The lower age
n the protocol approved by DCGI.
are the efficacy of intravenous (i.v.)
fpirome sulphate in the treatment of
nephritis with respect to
sessment (7+2 days post therapy).
of 7 days of for study drug
4 doses of Inj. Cefozopran or Inj.
otic treatment with Tab. Ciprofloxacin.
eive Tab. Ciprofloxacin (500 mg, 12
ay treatment period. The total duration
i.v. study drug followed by oral
nding upon the clinical condition of
extended to 14 days at the
ve study with an objective to compare
pran inj. 1 gm against Cefpirome, to be
ays (may be given up to 10 days) for
on and Pyelonephritis. The study
hical locations of India. The lower age
n the protocol approved by DCGI.
are the efficacy of intravenous (i.v.)
fpirome sulphate in the treatment of
nephritis with respect to
sessment (7+2 days post therapy).
of 7 days of for study drug
4 doses of Inj. Cefozopran or Inj.
otic treatment with Tab. Ciprofloxacin.
eive Tab. Ciprofloxacin (500 mg, 12
ay treatment period. The total duration
i.v. study drug followed by oral
nding upon the clinical condition of
extended to 14 days at the

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:- Sun, 08 Jan 2023 05:00:19 GMT)

rial Registered Retrospectively

TIVE MINIMAL INVASIVE SURGERY FOR
ON FOLLOWING INTRAPERITONEAL
TION OF ROPIVACAINE
APERITONEAL INSTILLATION OF
GEMENT FOLLOWING LAPROSCOPIC

Identifier
NIL
Details of Principal Investigator
Dr Anil Agarwal
Professor
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Department of Anesthesiology, Sanjay Gandhi Postgraduate Institute
of Medical Sciences, Lucknow
Lucknow
UTTAR PRADESH
226014
India

08004904589

anil_sgpgi@hotmail.com
Details Contact Person (Scientific Query)
Dr Anil Agarwal
Professor
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Department of Anesthesiology, Sanjay Gandhi Postgraduate Institute
of Medical Sciences, Lucknow
Lucknow
UTTAR PRADESH
226014
India

08004904589

anil_sgpgi@hotmail.com
Details Contact Person (Public Query)
Dr Anil Agarwal
Professor
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Department of Anesthesiology, Sanjay Gandhi Postgraduate Institute
of Medical Sciences, Lucknow
Lucknow
UTTAR PRADESH
 PDF of Trial
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226014
India
08004904589

anil_sgpgi@hotmail.com
Source of Monetary or Material Support
F MEDICAL SCIENCES,LUCKNOW
Primary Sponsor Details
SGPGIMS
SANJAY GANDHI POSTGRADUATE INSTITUTE OF MEDICAL
SCIENCES,LUCKNOW RAIBAREILLY ROAD,LUCKNOW-226014
Research institution and hospital
Address
NIL

Name of Site Site Address Phone/Fax/Email

SGPGIMS Urology OT-I,OT 08004019936

Complex, 1st dr.rajeevkumar2@gmail
Floor,Sanjay Gandhi .com
Postgraduate Institute
of Medical Sciences,Lu
cknow-226014
Lucknow
UTTAR PRADESH

Approval Status Date of Approval Is Independent Ethics

Committee?
Approved 28/01/2013 No

Date
No Date Specified
Condition
ASA-I and ASA-II
ASA-I and II
Name Details
Active comparator; Instillation Drug; Ropivacaine 100mg
Instillation group will receive
0.5%, 20 ml on kidney after
induction of pneumoperitoneum
but before dissection of kidney
 Active comparator; Instillation Drug; Ropivacaine 100mg
Instillation group will receive
0.5%, 20 ml on kidney after
induction of pneumoperitoneum
but before dissection of kidney

Experimental; Nebulization Drug; Ropivacaine 60 mg

nebulization group will receive
intraperitoneal nebulization of
ropivacaine 1%, 3 ml before the
start of renal dissection and
again at the end of surgery just
before deflation of
pneumoperitoneum.

Inclusion Criteria
18.00 Year(s)

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65.00 Year(s)
Both
ASA-I-II<br/> Scheduled for laparoscopic Nephrectomy<br/> Free
from pain in preoperative period<br/> Not using analgesic drugs
before surgery<br/> Without cognitive impairment or mental
retardation<br/> written informed consent

Exclusion Criteria
Patient under 18 or over 65 years
ASA III,IV or V
Emergency or urgency surgery
Postoperative admission in an intesive care unit
Severe hepatic or renal impairment
Pregnancy or lactation
Allergy to one of the specific drugs under study
Alcohol or drug addiction
Acute infection or chronic disease
Progressive degenerative disease of CNS
Seizures or chronic therapy with antiepileptic drugs
Cognitive impairment or mental retardation
Any type of communication problem
No written informed consent

d
Outcome Timepoints
 In PACU, At 6 hr,at 24 hr,at 48 hr and at the time
of discharge

Outcome Timepoints
In PACU,At 6 hr,at 24 hr,48 hr,at the time of
discharge
Intraoperative and Postoperative
Time in hours between PACU discharge and
when the patient able to walk
Time in hours elapsed between surgery and
hospital discharge
4 weeks after surgery

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ation for pain relief after laproscopic

ndomized,double blind study we assessed the
or pain relief after laproscopic donor

onor nephrectomy were randomly assigned

after induction of pneumoperitoneum or
urgery. Anesthetic and surgical techniques
breathing, incidence of shoulder pain,
stoperative nausea and vomiting were
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:- Sun, 08 Jan 2023 05:00:40 GMT)

rial Registered Retrospectively

eillance study to evaluate the efficacy and

ion
eting Surveillance study to evaluate safety
nd Disodium Edetate) in patients with various

Identifier
NIL
Details of Principal Investigator
Dr Yatin Mehta
Chairman
Institute of Critical Care and Anaesthesia
Medanta- The Medicity, Institute of Critical Care and Anaesthesia
Sector - 38, Gurgaon Haryana 122001, India
Gurgaon
HARYANA
122001
India

0124-4834469

Yatin.mehta@medanta.org
Details Contact Person (Scientific Query)
Dr Mohd Amin Mir
Director
Venus Remedies Limited
Venus Medicine Research Center, Venus Remedies Limited, Hill Top
Industrial Estate, Jharmajri EPIP Phase-1 Extension Bhatoli Kalan,
Baddi, Himachal Pradesh India
Solan
HIMACHAL PRADESH
173205
India

01795302051
01795271272
drmir@vmrcindia.com
Details Contact Person (Public Query)
Dr Mohd Amin Mir
 Dr Mohd Amin Mir
Director
Venus Remedies Limited
Venus Medicine Research Centre, Venus Remedies Limited, Hill Top
Industrial Estate, Jharmajri EPIP Phase-1 Extension Bhatoli Kalan,
Baddi, Himachal Pradesh India
Solan
HIMACHAL PRADESH

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173205
India
01795302051
01795271272
drmir@vmrcindia.com
Source of Monetary or Material Support
ear Jharmajri, E.P.I.P., Phase-I, (Extention)
de: 173 205, India

Primary Sponsor Details

Venus Remedies Limited
Plot No-51-52 Industrial Area Phase-1 Panchkula -134113 Haryana
(India)
Pharmaceutical industry-Indian
Address
NIL

Name of Site Site Address Phone/Fax/Email

AMRI Hospital Pulmonology and 09438554039

Critical Care drsarat2010@rediffmail.
Department Plot No. 1, com
Near Jayadev Vatika,
Khandagiri,
Bhubaneswar,
Odisha-751030
Cuttack
ORISSA
Apollo Hospital Senior consultant, 9840078979
Infectious Disease, 21, idisdoc@gmail.com
Greams Lane, off
Greams road Chennai,
600006
Chennai
TAMIL NADU

Batra Hospital & 1 Tughlakabad 9810113414

Medical Research Institutional Area, drssarora@gmail.com
Centre Mehrauli Badarpur
Road New Delhi-
110062 (India)
New Delhi
DELHI

Dayanand Medical Medicine department 9876080057

College & Hospital Tagore Nagar, Civil amitbery@yahoo.co.in
Lines, Near Rose
Garden, Ludhiana,
Punjab -141001
Ludhiana
PUNJAB

Dr. Ram Manohar Lohia Vibhuti Khand, Gomti 8176007063

Institute of Medical Nagar, Lucknow, Uttar drdm58@gmail.com
Sciences Pradesh 226010
Lucknow
UTTAR PRADESH

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Fortis Flt. Lt. Ranjan 9810048885

Dhall Hospital, Sector 01142776221
B, Pocket 1, Aruna Asaf viveknangia@gmail.co
Ali Marg, Vasant Kunj, m
New Delhi - 110070
New Delhi
DELHI

SMS Medical College & 09414044005

Attached Hospital, drclnawal@gmail.com
Jaipur
Jaipur
RAJASTHAN

Department of 9811946525
Pulmonology avi.kumar@fortishealth
New Delhi care.com
DELHI
Sector - 62, Phase - 09814338766
VIII, Mohali - 160062 911724692221
Chandigarh vishal.bhambri@fortish
CHANDIGARH ealthcare.com

ALL INDIA INSTITUTE 01126593676

OF MEDICAL randeepg@hotmail.com
SCIENCES Room No
102, 1 st Floor Old O.
T. Block, ANSARI
NAGAR, NEW DELHI
110029
New Delhi
DELHI

Kokilaben Dhirubhai 9320211770

Ambani Hospital & tanusinghal@yahoo.co
Medical Research m
Institute, Rao saheb
Achutrao Patwardhan
Marg, Four bungalows,
Andheri west, Mumbai
400 053
Mumbai
MAHARASHTRA

Dean Academic 8059931341

Department of Medicine onlybimal@gmail.com
Mullana, Ambala,
Haryana, India
Pin-133203
Ambala
HARYANA

Max Super speciality 01143033333

Hospital(A Unit of Balaji 01143170823
Medical & Diagnostic ranjana.chhabra@maxh
Research Centre), ealthcare.com
108-A, Indraprastha
Ext., Patparganj, New
Delhi-110092
New Delhi
DELHI

Medanta- The Medicity, 01244834469

Institute of Critical Care Yatin.mehta@medanta.
and Anaesthesia Sector org
- 38, Gurgaon Haryana

page 3 / 6

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 122001, India
Gurgaon
HARYANA
Postgraduate Institute Department of Urology 9417532955
of Medical Education & PGIMER, Sector-12, ravismi2003@yahoo.co
Research Chandigarh PIN- m
160012
Chandigarh
CHANDIGARH

Ruby Hall Clinic Ruby Hall Clinic 9960686867

Department of Critical prachee.sathe@gmail.c
Care Medicine, Ruby om
Hall clinic, Grant
Medical Foundation, 40,
Sassoon Road, Pune,
Maharshtra-411001
Pune
MAHARASHTRA

Sher-i-Kashmir Institute Department of 9419004822

of Medical Sciences Pulmonary Kashmir, parvaizk@gmail.com
Soura, Srinagar
190011, J&K (India)
Srinagar
JAMMU & KASHMIR

Approval Status Date of Approval Is Independent Ethics

Committee?
Approved 09/03/2015 No

Approved 18/02/2015 No

Approved 28/08/2018 No

Approved 30/06/2015 No

Approved 26/11/2019 No

Approved 15/04/2019 No

Approved 13/12/2017 No

Approved 15/03/2019 No
Approved 01/11/2014 No

Approved 29/10/2019 No

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Approved 07/01/2020 No

Approved 18/10/2019 No

Approved 10/11/2014 No

Approved 13/05/2013 No

Approved 03/08/2013 No
Approved 07/01/2020 No

Date
No Date Specified
Condition
Acute pyelonephritis
Direct infection of joint in infectious and parasitic
diseases classified elsewhere
Local infection of the skin and subcutaneous
tissue, unspecified
Pneumonia due to Klebsiella pneumoniae
Sepsis due to other Gram-negativeorganisms
Suppurative otitis media, unspecified
Name Details
ELORES 1.5 gm, IV, BD, 5-10 days
Not Applicable Not Applicable
Inclusion Criteria
1.00 Day(s)
 99.00 Year(s)
Both
Eligibility Criteria:<br/> 1. Patients with a suspected or confirmed
diagnosis of bacterial infection (labelled indications)<br/> 2. Patients
who receive a prescription of ELORES according to the indication
stated in the local<br/> approved SmPC [Lower Respiratory Tract
Infections, Urinary Tract Infections (complicated and<br/>
uncomplicated), Bacterial Septicaemia, Chronic Suppurative Otitis
Media, Infections of Bones<br/> and Joints, Infections of Skin and
Soft Tissues, Surgical Prophylaxis (including pre and
postsurgical<br/> infections)]<br/> 3. Written informed consent
signed by the patient or legally acceptable representative(s) in
line<br/> with applicable regulation of country.<br/> 4. Planned
treatment in line with the Summary of Product Characteristics, i.e.
exclusion of all<br/> patients with contraindications.

Exclusion Criteria
No Exclusion criteria in view of Non-Interventional Observational
PMS study.

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Outcome Timepoints
10 days

Outcome Timepoints
Observe of Clinical Cure rate at the end of
treatment

ble only for Completed/Terminated trials

ble only for Completed/Terminated trials
indications)

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:- Sun, 08 Jan 2023 05:01:06 GMT)

rial Registered Prospectively

 arallel group bioequivalence study of
Elmiron oral capsule 100 mg and both active
stitis/bladder pain syndrome
TROLLED, PARALLEL GROUP, 3 ARM,
N POLYSULFATE SODIUM, ORAL
TO ELMIRON ORAL CAPSULE 100 mg
INC) AND BOTH ACTIVE TREATMENTS
E TREATMENT OF INTERSTITIAL

Identifier
Protocol Number

Details of Principal Investigator

Mr Shawnavaz Vazeer
Clinical Operations Manager
Lotus Labs Pvt Ltd
Clinical Development Dept. Lotus Labs Pvt. Ltd., #141/2, Johns
Nagar,Opp. Koramangala BDA complex, 100ft. Road,3rd Block,
Koramangala, Bangalore. Mobile No: +91-9620211048
Bangalore
KARNATAKA
560034
India

91-80-25507462
91-80-25507461
shawnavaz_v@lotuslabs.com
Details Contact Person (Scientific Query)
Dr Sumit Arora
Head - Clinical Services
Lotus Labs Pvt Ltd
Lotus Labs Pvt Ltd Clinical Development Dept. No 7, Jasma Bhavan
Road, Opp. Gurunanak Bhavan, Millers Tank Bed Area,
Vasanthanagar, Bangalore - 560 052
Bangalore
KARNATAKA
560034
India

9731216421
91-80-25507461
sumit.arora@lotuslabs.com
Details Contact Person (Public Query)
Dr Sumit Arora
Head - Clinical Services
 PDF of Trial
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Lotus Labs Pvt Ltd

Lotus Labs Pvt Ltd Clinical Development Dept. No 7, Jasma Bhavan
Road, Opp. Gurunanak Bhavan, Millers Tank Bed Area,
Vasanthanagar, Bangalore - 560 052
Bangalore
KARNATAKA
560034
India

9731216421
91-80-25507461
sumit.arora@lotuslabs.com
Source of Monetary or Material Support
Additional Ambernath Anand Nagar,
l. No. +91 (0) 251 6949700 Fax No. +91 (0)

Primary Sponsor Details

Watson Pharma Pvt Ltd India
Watson Pharma Pvt. Ltd., Unit II Plot No. K-7, MIDC Additional
Ambernath Anand Nagar, Ambernath (East) Dist. Thane, Pin– 421
506, India. Tel. No. +91 (0) 251 6949700 Fax No. +91 (0) 251
3084800

Pharmaceutical industry-Global
Address
Nil

Name of Site Site Address Phone/Fax/Email

Inamdar Multispeciality Inamdar Multispeciality 9822059799

Hospital Hospital, (-2 Floor), drshamsi@hotmail.com
Dept of Urology, Room
No. 1, Hospital Building
S. No. 15, Fatima
Nagar, Pune - 411 040.
India
Pune
MAHARASHTRA
Apollo Hospitals Apollo Hospitals, 04023431725
Ground Floor, Suit No prudhvi.s@aherf-smo.o
042, Dept of Urology, rg
Apollo Health city,
Jubilee Hills,
Hyderabad-500096 AP
Hyderabad
ANDHRA PRADESH

B.J. Govt. Medical BJ Medical College & 9823949126

College and Sassoon Sassoon general drkpjadhav@hotmail.co
General Hospital hospital, Main Building, m
First Floor, Dept of
Surgery,J P Narayan
Road, Pune Station
Sasoon Road, Pune
Maharashtra
Pune
MAHARASHTRA

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Care Institute of 9824022035

Medical sciences nagendraad1@yahoo.c
(CIMS), Urology om
Department, Ground
Floor, Near Shukan
mall, off science city
road, sola,
Ahmedabad-380060
Gujarat
Ahmadabad
GUJARAT

Christian Medical 9814034185

College, Department of kjmammen@gmail.com
Urology, First Floor,
Christian Medical
College Brown
Road,CMC Campus,
Ludhiana-141008
Punjab
Ludhiana
PUNJAB
Dept of Medicine, Office 9815532533
No - 2, Second Floor, drjaindinesh@yahoo.co
Dayanand Medical .in
College, D.M.C.
Road,Tagore Nagar,
Ludhiana- 141001
Ludhiana
PUNJAB

Fortis Escorts Hospital, 9829696995

Ground Floor, Jawahar drjainalok@gmail.com
Lal Nehru Marg,
Malviya Nagar Jaipur,
RAJASTHAN
Jaipur
RAJASTHAN

GCS Medical College, 9227205424

Hospital & Research drshashank11@gmail.c
Centre, Ground Floor, om
Roon No 9, Dept Of
Sugery, Naroda Rd, D
Colony,
Ahmedabad-380025
Gujarat
Ahmadabad
GUJARAT

Global Hospital, Kidney 9445950701

Institute, First Floor, muthuv65@hotmail.co
Global Health city, m
Medavakkam to
sholinganallur Rd,
Medavakkam, 439,
Cheran Nagar,
Perumbakkam,
Chennai - 600 100,
Tamil Nadu
Chennai
TAMIL NADU

Kasturba Hospital 9008002440

page 3 / 12

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Manipal, Room no 14, urologyarun@yahoo.co

First Floor, Madhav m
Nagar, Manipal -
576104, Karnataka
Dakshina Kannada
KARNATAKA
King George Hospital, 9246626484
Department of Urology, drchodisetti@yahoo.co.i
First Floor, Jagadamba n
Area, KGH down road,
Maharani Peta
Visakhapatnam - AP
Visakhapatnam
ANDHRA PRADESH

Medipoint Hospitals 9822191175

Pvt.Ltd, OPD Building, ashishpardeshi.pentago
3rd Floor, Research n@gmail.com
Dept, 241/1, New D P
Road,Aundh, Pune-411
007
Pune
MAHARASHTRA

Monilek Hospital & 9829696995

Research, Dept of drjainalok@gmail.com
Urology, Ground Floor,
Room No 2103,
Sector-4, Jawahar
Nagar, Jaipur -302004
Rajasthan
Jaipur
RAJASTHAN

Muljibhai Patel 02682520323

Urological Hospital, Uro rbsabnis@gmail.com
Office, Ground Floor,
Dr.V.V.Desai Rd,
Nadiad-387001 Kheda -
Gujarat
Kheda
GUJARAT

Postgraduate Institute 9914209326

of Medical Education & shrawanksingh2002@y
Research, Nehru ahoo.com
Hospital, Department of
Urology, Second Floor,
B Block, Sector-12,
Chandigarh
Chandigarh
CHANDIGARH

Rushabh Uro Hospital 9824086834

2nd floor, Heritage drshreniks@gmail.com
Plaza, Opp. Gurukul
Tower, Drive in Road,
Ahmedabad - 380052
Ahmadabad
GUJARAT

Samved Urology 07926420285

hospital, Second Floor, drjanak@samvedurolog
Near Stadium Circle, y.com
Navrangpura,
 page 4 / 12

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Ahmedabad, Gujarat,
380009
Ahmadabad
GUJARAT
Sir Ganga Ram Sir Ganga Ram 9810195227
Hospital Hospital, Department of sk1957@gmail.com
Urology, 2nd Floor, Sir
Ganga Ram Hospital,
Sir Ganga Ram
Hospital Marg, Rajindra
Nagar, New Delhi-60
New Delhi
DELHI

SMS Medical college & SMS Medical college & 9414515858

hospital hospital, Room No 63 - dryadavsms@gmail.co
J, First Floor, m
Department of
Nephrology, SMS
Medical college &
hospital, Ashok Nagar,
Jaipur, Rajasthan
Jaipur
RAJASTHAN

Sri Venkateshwara Sri Venkateshwara 91-80-40416789

Hospital Hospital, Consultant drraghunathsk@yahoo.
Medical Urologist, com
Ground Floor, #86,
Hosur Main Road,
Madiwala,
Bangalore-560068.
Bangalore
KARNATAKA

St. John’s Medical St. John’s Medical 08026614062

College & Hospital College & Hospital, mohan.urology@gmail.
Urology Project Office, com
4th Floor, Department
of Urology, St. John’s
Medical College &
Hospital, John Nagar,
Kormangala Bangalore,
Karnataka 560034
Bangalore
KARNATAKA
Supe Heart & diabetes Supe Heart & diabetes 9892706382
Hospital & Research Hospital & Research drsharadprasad@gmail.
centre centre, First Floor, com
Dept. of Urology,
Opposite to
Adharashram,
Gharpure ghat, Near
Rungtha Highschool,
Ashok Stambh, Nashik
- 422002
Nashik
MAHARASHTRA

Approval Status Date of Approval Is Independent Ethics

Committee?
Submittted/Under No Date Specified No
Review

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No Date Specified No

No Date Specified No

No Date Specified No
No Date Specified No

No Date Specified No

No Date Specified No

No Date Specified No

No Date Specified No

25/07/2013 No

page 6 / 12

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No Date Specified No

No Date Specified No

No Date Specified No

30/05/2013 No

No Date Specified No

No Date Specified No

No Date Specified No
No Date Specified No

page 7 / 12

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Approved 06/05/2013 No

Approved 23/06/2013 No

Submittted/Under No Date Specified No

Review

Submittted/Under No Date Specified No

Review

Date
09/12/2013
Condition
Interstitial Cystitis/Bladder Pain Syndrome
Name Details
Pentosan Polysulfate Sodium Oral Capsule 100 mg of Watson
Pharma Pvt. Ltd., India. 176
patients out of 528 will receive
intervention drug. Each patients
(176) will receive one capsule
each orally three times daily for
90 days.
 Pentosan Polysulfate Sodium Oral Capsule 100 mg of Watson
Pharma Pvt. Ltd., India. 176
patients out of 528 will receive
intervention drug. Each patients
(176) will receive one capsule
each orally three times daily for
90 days.

Elmiron (Pentosan Polysulfate Oral Capsule 100 mg of

Sodium) Ortho?Mcneil?Janssen
Pharmaceuticals, Inc. 176
patients out of 528 will receive
comparator (Elmiron) drug.
Each patients (176) will receive
one capsule each orally three
times daily for 90 days.

Placebo Test placebo of Watson Pharma

Pvt. Ltd., India. 176 patients out
of 528 will receive comparator
(placebo) drug. Each patients
(176) will receive one capsule
each orally three times daily for

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90 days.
Inclusion Criteria
18.00 Year(s)
65.00 Year(s)
Both
1. Males and females aged more than 18 years with moderate to
severe interstitial cystitis <br/> 2. Patient has experienced bladder
pain, urinary urgency and urinary frequency, each not related to a
urinary tract infection, for at least the previous 6 months prior to entry
into the study. <br/> 3. An average voided bladder volume of 50 to
200 mL (as determined over 3 consecutive days documented in the
urinary frequency diary). <br/> 4. Urine culture negative for clinically
significant urinary tract infection (at baseline or within 2 weeks prior
to baseline visit). <br/> 5. Urine cytology negative for neoplastic cells
(at baseline or within 2 months prior to baseline visit). <br/> 6.
Cystoscopic examination under anesthesia by the investigator
showing petechial hemorrhages or ulcers following one or two
distentions of the bladder at 80 cm of water pressure for one minute
performed within 6 months prior to baseline visit and at least 6 weeks
prior to baseline visit. Patients that enter remission after their
cystoscopic examination should not be scheduled for their baseline
visit until the symptoms reappear. <br/> 7. Patients currently being
treated with Pentosan Polysulfate Sodium may be enrolled in the
study if Pentosan Polysulfate Sodium treatment is stopped at least
for 4 weeks (wash-out period) prior to baseline visit.

Exclusion Criteria
1. More than 25 voids per day
2. Bladder capacity of more than 350 mL during awake exam
3. Patient is planning to use intravesical therapy for interstitial cystitis
within one month prior to baseline visit.
4. Patient planning to use medical treatment for interstitial cystitis
within one month prior to baseline visit.
5. Patient taking any anticoagulants
6. Patient with known aneurysm, thrombocytopenia, hemorrhagic
disease, hemophilia, or gastrointestinal ulceration (e.g., active
bleeding peptic ulcer disease), polyps, or diverticula.
7. Patient with known hypersensitivity to Pentosan Polysulfate
Sodium, including excipients (microcrystalline cellulose and
magnesium stearate), or heparin.
8. Patient who has a history of, or currently has, any of these:
Neurogenic bladder or diabetic cystopathy, Pelvic irradiation or
chemical cystitis, including that due to cyclophosphamide, Presence
of urethral, pelvic, or rectal carcinoma, Benign or malignant bladder
tumors, Tuberculous cystitis, Urinary schistosomiasis, Bladder or
ureteral calculi, Active genital herpes within 3 months prior to study
entry, Urethral and/or bladder obstruction, Augmentation cystoplasty,
cystectomy, cystolysis, neurectomy or implanted peripheral nerve
stimulator that has affected bladder function.
9. Patient has microscopic hematuria as defined as 5 RBC/high
power field at baseline visit without a negative workup within the last
year.
10. Patient has current chronic pain condition
11. Patient has clinically significant hepatic disease or clinically
significant abnormal liver function tests.
Gender specific exclusion criteria:
Male: 1) Patient has a post-void residual volume of 150 cc by
ultrasound. 2) Patient had a Trans Urethral Resection of Prostate
(TURP), Trans Urethral Incision of Prostate (TUIP), Trans Urethral
 PDF of Trial
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Incision of Bladder Neck (TUIBN), Trans Urethral Microwave

Thermotherapy (TUMT), Trans Urethral Needle Ablation (TUNA),
balloon dilation of the prostate, open prostatectomy or any other
prostate surgery or treatment such as cryotherapy or thermal
therapy. 3) Patient has a history of prostate cancer. 4) Patient is
currently being treated for chronic bacterial prostatitis.
Female: 1) Patient has a positive pregnancy test at the baseline visit,
is pregnant or lactating, or is planning to become pregnant during the
study period. 2) Patient has a history of uterine, cervical or vaginal
cancer during the past 3 years. 3) Patient has clinically significant
vaginitis at baseline visit.

Outcome Timepoints
Patient participation will last for 91 days (90 days
of double-blind study treatment).
Clinical Evaluations will be performed at:
Visit 1: Pre-screening (Day-3)
Visit 2: Baseline / Randomization Visit (Day 1)
Visit 3: First Interim Visit (Day 15 ± 4 Days)
Visit 4: Second Interim Visit (Day 30 ± 4 Days)
Visit 5: Third Interim Visit (Day 60 ± 4 Days)
Visit 6: End of Treatment Visit (Day 90 ± 4 Days)

Outcome Timepoints
Patient participation will last for 91 days (90 days
of double-blind study treatment).
Clinical Evaluations will be performed at:
Visit 1: Pre-screening (Day-3)
Visit 2: Baseline / Randomization Visit (Day 1)
Visit 3: First Interim Visit (Day 15 ± 4 Days)
Visit 4: Second Interim Visit (Day 30 ± 4 Days)
Visit 5: Third Interim Visit (Day 60 ± 4 Days)
Visit 6: End of Treatment Visit (Day 90 ± 4 Days)

ble only for Completed/Terminated trials

ble only for Completed/Terminated trials
 PDF of Trial
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uivalence Study With Clinical Endpoint with a randomized,

placebo controlled design, at approximately 20
lish bioequivalence of Pentosan Polysulfate Sodium, Oral
PVT. LTD.) and Elmiron Oral Capsule 100 mg
ticals, Inc) in the treatment of interstitial

valence of the efficacy and safety of Pentosan Polysulfate

ATSON PHARMA PVT. LTD.) and Elmiron Oral
Pharmaceuticals, Inc) in the treatment of

efficacy of Pentosan Polysulfate Sodium, Oral Capsule

and Elmiron Oral Capsule 100 mg (Ortho
the treatment of interstitial cystitis / bladder
 (176:176:176), with bladder pain associated with
nrolled and randomized in the treatment allocation ratio of
ebo in order to achieve 420 (140:140:140) patients in the
e overall dropout rate from the randomized patients to PP
er of PPS non-naïve subjects enrolled in study should not

pation will last for 91 days (90 days of double-blind study

eive Investigational Medicinal Product (IMP) one capsule

randomization. The capsules should be taken with
eals or 2 hour after meals. The patients receiving IMP will
throughout the study for the efficacy and safety. For each
aluation will be assessed after 3 months of treatment (i.e.,

be used for this study where the patient population will be

s of PPS naïve & PPS non-naïve. Thereafter, patients will
atment allocation ratio of 1:1:1 to receive the Test product
Placebo, respectively in each stratum. The randomization
non-study assigned, independent expert using

page 11 / 12

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the third party vendor of the CRO i.e.

copy of the randomization scheme will be
available to FDA investigators at the time of site
assigned to each subject.
 proportion of patients in the per protocol
occurring after three months of treatment
treatment visit, a two-sided 90% confidence
oportions (PT – PR) between test and reference
-0.20] in order to establish equivalence.

study sensitivity, the test product and RLD

with regard to the “treatment success”
ent (at the visit no. 6, Day 90 ± 4days) using the
pulation, with and without last observation carried

the placebo (vehicle control) to establish

ebo for the treatment success rate at the end of
be conducted independently for test and
ll be claimed if the two-sided p-value is < 0.05 at
products separately.

difference in means of the primary efficacy

PPS non-naïve patients. Number of PPS

needing add-on/rescue therapy in each arm and

each arm can be compared, supporting

page 12 / 12

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:- Sun, 08 Jan 2023 05:01:33 GMT)

rial Registered Retrospectively

s alfuzosin, tamsulosin and silodosin in

redominantly causing urinary problems in

osin, tamsulosin and silodosin in benign

Identifier
NIL
Details of Principal Investigator
Dr Manjunatha R
Doctor
Kempegowda Institute Of Medical Sciences.
Post graduate, Department of Pharmacology, Kempegowda Institute
of Medical Sciences, Banashankari 2nd stage, Bangalore.
Bangalore
KARNATAKA
560070
India

8951155519

manjunatha5ramaiah@gmail.com
Details Contact Person (Scientific Query)
Dr H P Pundarikaksha
Professor and Head, Department of Pharmacology, KIMS,
Bangalore.
Kempegowda Institute Of Medical Sciences.
Dr Manjunatha R, Post graduate student doing the thesis, Guidance :
Dr H P Pundarikaksha, Department of Pharmacology, Kempegowda
Institute of Medical Sciences, Banashankari 2nd stage, Bangalore.
manjunatha5ramaiah@gmail.com
Bangalore
KARNATAKA
560070
India

8951155519

drpundarikahp@gmail.com
Details Contact Person (Public Query)
 Details Contact Person (Public Query)
Dr Manjunatha R
Doctor
Kempegowda Institute Of Medical Sciences.
Post graduate, Department of Pharmacology, Kempegowda Institute
of Medical Sciences, Banashankari 2nd stage, Bangalore.
Bangalore

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KARNATAKA
560070
India
8951155519

manjunatha5ramaiah@gmail.com
Source of Monetary or Material Support

Primary Sponsor Details

Dr Manjunatha R
Department Of Pharmacology, Kempegowda Institute Of Medical
Sciences, Banashankari 2nd stage, Bangalore 560070.
Other [Dr Manjunatha R]
Address
NIL

Name of Site Site Address Phone/Fax/Email

Kempegowda Institute Department of Urology, 8951155519

of Medical Sciences Surgical super specialty manjunatha5ramaiah@
Hospital and Research OPD, First floor, B gmail.com
Centre Block, KIMS Hospital
and Research Centre,
V V Puram, Bangalore
560004.
Bangalore
KARNATAKA

Approval Status Date of Approval Is Independent Ethics

Committee?
Approved 15/11/2012 No
 Date
No Date Specified
Condition
Benign Prostatic hyperplasia
Name Details
Silodosin 8mg OD for 3 months, oral
administration.
Alfuzosin 10mg OD for 3 months, oral
administration.
Tamsulosin 0.4mg OD for 3 months, oral
administration.

Inclusion Criteria
45.00 Year(s)
90.00 Year(s)
Male
Male subjects more than or equal to 45 years with BPH and
associated LUTS; <br/> IPSS more than or equal to 8.<br/> QLS
more than or equal to 3.<br/> Qmax less than 15ml but more than

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4ml with a voided volume of more than 100ml.<br/> willingness to

give written informed consent and comply with the study procedure,
and available for regular follow up.

Exclusion Criteria
 Patients already on 5 alpha reductase inhibitors.
Severe hepatic or renal insufficiency.
Patients concomitantly receiving strong CYP3A4 inhibitors.
UTI.
Urethral stricture.
Neurogenic bladder.
PSA more than or equal to 5ng/ml.
History of urethral or prostatic operation.
Likely to need catheterization within next 3 months.
Hypotension or severe untreated hypertension.
History of esophageal or intestinal obstruction.
Patients receiving drugs that may interfere with the response to
study medications within previous 6 months like verapamil,
androgens, anti-androgens, diuretics, cholinergics, anti-cholinergics
and phytotherapy.
History of alcohol or drug abuse.
Currently suffering from serious disease or malignancy.
Significant psychiatric problems.
Patients at increased risk of QTc prolongation.

Outcome Timepoints
2, 4, 8 and 12 weeks

Outcome Timepoints
2, 4, 8 and 12 weeks.

ble only for Completed/Terminated trials

ble only for Completed/Terminated trials

on comparative efficacy and

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osin in patients with benign prostatic hyperplasia (BPH)

d Research Centre, V V Puram, Bangalore, India. The
hree groups of 30 in each, using 1:1:1 randomization
0 mg or silodosin 8 mg. Alfuzosin SR
before meals) will be given once daily at bedtime and
the three study medications
e primary endpoint for evaluation of efficacy is change
oints are change in Qmax (peak flow rate) and evaluation
orage scores and quality of life score.

instructed not to crush, chew or open the capsule/tablet

and to contact the doctor immediately in the event of
page 4 / 4

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 :- Sun, 08 Jan 2023 05:01:45 GMT)

rial Registered Prospectively

ey stones
e efficacy and safety of IBHB tablets in the

Identifier
Protocol Number
Details of Principal Investigator
Dr Rajendra Shimpi
Coordinating investigator
Inamdar Multispeciality Hospital
Research Room, Basement 2, Urology Department, Inamdar
Multispeciality Hospital, Hospital Building, S.NO.15, Fatima
Nagar,Pune
Pune
MAHARASHTRA
411040
India

91206137494
912026055094
rajendrakshimpi@gmail.com
Details Contact Person (Scientific Query)
Dr Prasad Thakurdesai
General Manager, Scientific affairs
Indus Biotech Private Limited
1, Rahul Residency, Plot Nos 6 & 7, Off Salunke Vihar Road,
Kondhwa, Pune
Pune
MAHARASHTRA
411048
India

912064785063
912026850039
prasad@indusbiotech.com
Details Contact Person (Public Query)
Pallavi Deshpande
Clinical Research Associate
Indus Biotech Private Limited
 1, Rahul Residency, Plot Nos 6 & 7, Off Salunke Vihar Road,
Kondhwa, Pune
Pune
MAHARASHTRA
411048
India

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912064785063
912026850039
pallavi@indusbiotech.com
Source of Monetary or Material Support

Primary Sponsor Details

Indus Biotech Private Limited Pune
1, Rahul Residency, Plot Nos. 6 & 7, Off Salunke Vihar Road,
Kondhwa, Pune 411 048
Pharmaceutical industry-Indian
Address
NIL

Name of Site Site Address Phone/Fax/Email

Bhakti Vedanta Hospital Department of Urology, 918879614446

2nd Floor, Dr. Siva g.sivaprasad@yahoo.c
Prasad’ OPD, Bhakti om
Vedanta Hospital,
Srishti Complex, Bhakti
Vedanta Swami Marg,
Mira Road (East), Dist-
Thane- 401107,
Maharashtra, India.
Thane
MAHARASHTRA
 Bhatia General Hospital Room NO. 5, Ground 912266660000
Floor,G1 Department, 912266660566
Bhatia General drpratit@gmail.com
Hospital, Zoroastrian
Colony, Tardeo Road ,
Grant Road
(W),Mumbai-400007,
Maharashtra, India
Mumbai
MAHARASHTRA

Brahma-Kumaris BSES BSES Municipal 912266487570

M G Hospital General 912226114500
Hospital,Department of drneil4ever@yahoo.co
Urology, Clinic No. 01, m
2nd floor, Opp.
Merwans Bakery, S.V.
Road, Andheri (W),
Mumbai-400058, India.
Mumbai (Suburban)
MAHARASHTRA

Inamdar Hospital Research Room No. 0206137494

1,Floor Basement 2, 02026055094
Department of rajendrakshimpi@gmail
Urology,Inamdar .com
Multispeciality Hospital,
Hospital Building,
S.NO.15, Fatima
Nagar,Pune-411040,

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Maharashtra,
IndiaHospital Building,
S.NO.15, Fatima
Nagar,Pune-411040,
Maharashtra, India
Pune
MAHARASHTRA

Muljibhai Patel Department of Urology, 919426422002

Urological Hospital OPD number 10, 11 & rbsabnis@gmail.com
12, First Floor, Muljibhai
Patel Urological
Hospital, Dr. Virendra
Desai Road, Nadiad-
387001, Gujarat, India.
Kheda
GUJARAT
Rushabh Uro Hospital 2nd Floor, Heritage 919824086834
Plaza, Opp. Gurukul drshreniks@gmail.com
Tower, Drive in Road,
Ahmedabad – 380052,
Gujarat, India.
Ahmadabad
GUJARAT

Approval Status Date of Approval Is Independent Ethics

Committee?
Approved 26/05/2014 No

Approved 14/01/2014 No

Approved 18/12/2013 No

Approved 27/11/2013 No

Approved 19/09/2014 No

Approved 06/08/2014 No

Date
No Date Specified
Condition
Urinary calculus, unspecified
urolithiasis
Name Details
IBHB tablets IBHB tablets (300 mg, one
tablet, twice a day orally) for 12

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 weeks
Placebo tablets Placebo tablets (300 mg, one
tablet, twice a day orally) for 12
weeks

Inclusion Criteria
18.00 Year(s)
65.00 Year(s)
Both
1) Males or females aged 18 to 65 years, both inclusive.2)
Symptomatic and asymptomatic cases with radiographic evidence
(abdominal USG report up to two weeks prior to screening will be
accepted) of diagnosis of renal calculi 3) In case of subjects with
multiple calculi, at least one calculus must be 5 mm and all calculi
should be 10 mm 4) Subjects willing to refrain from the use of any
other herbal treatment for urolithiasis during the entire course of the
study 5) Subjects willing to adopt a reliable and effective method of
contraception during the course of the study such as abstinence, oral
contraceptive pills, barrier method, etc 6) Subjects willing to provide
a written informed consent

Exclusion Criteria
1) Subjects with urinary tract infection 2) Subjects with obstructive
uropathy 3) Subjects with known metabolic or endocrinal disorders
favouring calculus formation 4) Subjects with known history of
hypersensitivity to lactose 5) Subjects with malignancy 6) Subjects
with poorly controlled diabetes as observed by a HbA1c of >10% 7)
Subjects suffering from chronic systemic illnesses like rheumatoid
arthritis,psychoneural-endocrinal disorders, etc necessitating long
term therapy 8) Subjects with a history of atrial fibrillation, coronary
artery disease, acute coronary syndrome,myocardial infarction,
stroke or severe arrhythmia in the past 6 months 9) Subjects with
poorly controlled hypertension, as observed by a blood pressure
(BP) reading of >160/100 mm Hg in the supine position 10) Subjects
on prolonged treatment with corticosteroids, antidepressants,
anticholinergics, etc or any other medication that may have an
influence on the outcome of the study. Subjects should not have
consumed any of these for at least six weeks prior to screening 11)
Subjects with severe hepatic disorder, defined as AST, ALT, total
bilirubin, and ALP levels >2 times ULN or renal disorder, defined as
serum creatinine levels >1.2 mg/dL 12) Subjects with severe
pulmonary dysfunction such as uncontrolled bronchial asthma and/or
chronic obstructive pulmonary disease, inflammatory bowel disease,
or any other condition which could influence the outcome of the
study 13) Subjects who are currently dependent on or abusing,
alcohol or one or more of the following: cannabis, cocaine,
hallucinogens, inhalants, opioids, sedatives or hypnotics 14)
Subjects with known hypersensitivity to the investigational product or
its ingredients 15) Subjects with a history of food allergy 16) Subjects
with known allergy to diclofenac sodium 17) Subjects who have
participated in any other investigational study in the past 6 months
18) Subjects with known HIV, Hepatitis B or Hepatitis C infections
19) Subjects with a positive pregnancy test at screening or who is a
lactating female 20) Subjects with any medical condition that in the
investigator’s opinion may threaten the subject’s ability to complete
the study
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entry Operator Blinded

Outcome Timepoints
At randomization visit (baseline) and at 12 week
(end of study)

Outcome Timepoints
At randomization visit (baseline) and at 12 week
(end of study)

ble only for Completed/Terminated trials

ble only for Completed/Terminated trials

ting the quality of life of the affected

howed excellent safety profile in toxicological
ey stone in terms of reduced number of
ial areas of tubular epithelial cells with
(TDI).
zed pilot study objective is aimed at
ets twice daily) in patients with Urolithiasis for
receive test drug or placebo in ratio of 1:1.
on of subjects with reduction in the size of
re proportion of subjects with reduction in the
n in the diameter of largest renal calculus,
 ting the quality of life of the affected
howed excellent safety profile in toxicological
ey stone in terms of reduced number of
ial areas of tubular epithelial cells with
(TDI).
zed pilot study objective is aimed at
ets twice daily) in patients with Urolithiasis for
receive test drug or placebo in ratio of 1:1.
on of subjects with reduction in the size of
re proportion of subjects with reduction in the
n in the diameter of largest renal calculus,
in the pH of urine and estimated creatinine
ount of analgesics consumed, QoL by
er of drop-out subjects, number of patients
l signs and lab parameters.

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:- Sun, 08 Jan 2023 05:01:59 GMT)

rial Registered Retrospectively

penis for diagnostic cystoscopy -

echniques.
s add on to topical anaesthesia for diagnostic
ree different techniques.
Identifier
NIL
Details of Principal Investigator
Dr ANIL VERMA
SENIOR RESIDENT , UROLOGY
JIPMER
 DEPARTMENT OF UROLOGY, JIPMER DEPARTMENT OF
UROLOGY, JIPMER
Pondicherry
PONDICHERRY
605006
India

9489314086

chotitop@gmail.com
Details Contact Person (Scientific Query)
Dr L N Dorairajan
Professor, Urology
jipmer
Department of urology, JIPMER Department of urology, JIPMER
Pondicherry
PONDICHERRY
605006
India

919442572804

dorairajan_ln@hotmail.com
Details Contact Person (Public Query)
Dr L N Dorairajan
Professor, Urology
jipmer
Department of Urology, JIPMER Department of Urology, JIPMER
Pondicherry
PONDICHERRY
605006
India

919442572804

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dorairajan_ln@hotmail.com
Source of Monetary or Material Support

Primary Sponsor Details

JIPMER Pondicherry
 Department of Urology JIPMER Pondicherry Pin 605006
Research institution and hospital
Address
NIL

Name of Site Site Address Phone/Fax/Email

Department of urology , Room No 438, 0413-2297335

JIPMER Superspeciality Block, dorairajan_ln@hotmail.
JIPMER, Pondicherry com
Pin 605006
Pondicherry
PONDICHERRY

Approval Status Date of Approval Is Independent Ethics

Committee?
Approved 28/02/2013 No

Date
No Date Specified
Condition
Carcinoma Bladder
Name Details
Rigid cystoscopy under Corpus A single injection of 3 ml of 1%
spongiosal block Inj Lidocaine into glans penis in
addition to adequate volume of
2 % Lidocaive jelly instilled
perurethra prior to rigid
diagnostic cystosocpy

Rigid cystoscopy under 2% Topical anaesthesia using

Topical anaesthesia adequate volume of 2%
Lidocaine jelly instilled
perurethra prior to rigid
diagnostic cystoscopy

Flexible cystoscopy under 2% Topical anaesthesia using

topical anaesthesia adequate volume of 2%
Lidocaine jelly instilled
perurethra prior to diagnostic
cystoscopy using flexible
cystoscope

Inclusion Criteria
18.00 Year(s)
95.00 Year(s)
Male
1. Male patients 18 years or above who are scheduled to undergo
diagnostic cystoscopy as elective procedure for suspected case of
 PDF of Trial
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bladder cancer.<br/> 2. Check cystoscopy performed for carcinoma

bladder.<br/>
Exclusion Criteria
Urethral strictures.
Known allergy to lignocaine.
Associated urological co-morbidities like urethral or vesical calculus,
neurovesical dysfunction.
Significant cardiovascular disease
Active UTI

Outcome Timepoints
one hour after the procedure

Outcome Timepoints
1 hour

ble only for Completed/Terminated trials

ble only for Completed/Terminated trials
er in a patient with a history of hematuria or in
using either a rigid or a flexible endoscope.
y of the urethra and the urinary bladder and
specific advantages and disadvantages that
. Rigid endoscopes have advantage of
better visualization; they are easier to
edure is perceived as being uncomfortable to
topical anesthesia as compared to flexible
ope include improved patient comfort,
assage over an elevated bladder neck or
life, the greater cost of the equipment and a
iosum block has been described for optical

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has been described as a simple, safe and

o general or spinal anesthesia in a recent
nsive procedure. In the present study we wish to find
orpus spongiosum block as add on to topical
der topical anesthesia and is comparable or better than
can then be more effective, safe and cost
 page 4 / 4

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:- Sun, 08 Jan 2023 05:02:06 GMT)

rial Registered Retrospectively

ndex and ring finger and occurrence and

ulting in urinary problems, commonly seen in

measures of benign prostatic hyperplasia in

Identifier
NIL
Details of Principal Investigator
Dr Manjunatha R
PG cum Tutor, Department of Pharmacology.
Kempegowda Institute Of Medical Sciences.
Department of Pharmacology, Kempegowda Institute of Medical
Sciences, Banashankari 2ND stage, Bangalore
Bangalore
KARNATAKA
560070
India

8951155519

manjunatha5ramaiah@gmail.com
Details Contact Person (Scientific Query)
Dr Sudhakar H H
Professor and Head, Department of Physiology.
Kempegowda Institute Of Medical Sciences.
Department of Physiology, Kempegowda Institute of Medical
Sciences, Banashankari 2ND stage, Bangalore
Bangalore
KARNATAKA
560070
India

9844521274

haddinakallu@yahoo.com
Details Contact Person (Public Query)
 Details Contact Person (Public Query)
Dr Sudhakar H H
Professor and Head, Department of Physiology.
Kempegowda Institute Of Medical Sciences.
Department of Physiology, Kempegowda Institute of Medical
Sciences, Banashankari 2ND stage, Bangalore
Bangalore
KARNATAKA
560070
India

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9844521274

haddinakallu@yahoo.com
Source of Monetary or Material Support

Primary Sponsor Details

Dr Manjunatha R
Department of Pharmacology, Kempegowda Institute of Medical
Sciences, Banashankari 2ND stage, Bangalore.
Other [self]
Address
NIL

Name of Site Site Address Phone/Fax/Email

Kempegowda Institute Department of Urology 8951155519

of Medical Sciences (Division of Surgical manjunatha5ramaiah@
Hospital and Research Superspecialties), First gmail.com
Centre floor, B Block,
Kempegowda Institute
of Medical Sciences
Hospital and Research
Centre, V V Puram,
Bangalore 560004.
Bangalore
KARNATAKA

Approval Status Date of Approval Is Independent Ethics

Committee?
 Approval Status Date of Approval Is Independent Ethics
Committee?
Approved 17/05/2013 No
Date
No Date Specified
Condition
Patients of benign prostatic hyperplasia who are
otherwise healthy will be recruited as cases and
normal healthy volunteers will be taken as
controls.

Name Details
The second to fourth digit ratios The second to fourth digit ratios
of normal healthy volunteers will of normal healthy volunteers will
act as control or comparator act as control or comparator
with which the the second to with which the the second to
fourth ratios of patients of BPH fourth ratios of patients of BPH
will be compared. will be compared.

Inclusion Criteria
45.00 Year(s)
90.00 Year(s)
Male
Male subjects aged between 45 – 90 years with different radiological
grades of BPH with clinical symptoms.

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Exclusion Criteria
Subjects who have undergone any form of surgery for BPH.
Subjects on medical treatment for BPH for more than 12 weeks.

Outcome Timepoints
Not applicable

Outcome Timepoints
Not applicable

ble only for Completed/Terminated trials

ble only for Completed/Terminated trials
ble only for Completed/Terminated trials
ble only for Completed/Terminated trials

ker for prenatal androgen exposure. A low

n exposure. Measure of 2D:4D ratio as a non
en exposure is widely adopted by researchers
sterone exposure in developing
life is found to affect several attributes of
ct to the growth of prostate in adult life and its
ked with prostatic cancer. Studies have not
atal androgen exposure levels on the growth
LASIA (BPH). This study is an indirect
ation to the development of BPH.

D ratio and incidence of BPH

rity of BPH

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:- Sun, 08 Jan 2023 05:02:15 GMT)

rial Registered Retrospectively

rial Registered Retrospectively

m health benefits with minimum spending by

ns in the treatment of benign prostatic
othersome urinary problems.
sulosin and silodosin in benign prostatic

Identifier
NIL
Details of Principal Investigator
Dr Manjunatha R
Post graduate cum tutor, Department of Pharmacology.
Kempegowda Institute Of Medical Sciences.
Department of Pharmacology, Kempegowda Institute of Medical
Sciences, Banashankari 2ND stage, Bangalore.
Bangalore
KARNATAKA
560070
India

8951155519

manjunatha5ramaiah@gmail.com
Details Contact Person (Scientific Query)
Dr H P Pundarikaksha
Professor and Head, Department of Pharmacology.
Kempegowda Institute Of Medical Sciences.
Department of Pharmacology, Kempegowda Institute of Medical
Sciences, Banashankari 2ND stage, Bangalore.
Bangalore
KARNATAKA
560070
India

9880052054

drpundarikahp@gmail.com
Details Contact Person (Public Query)
Dr H P Pundarikaksha
Professor and Head, Department of Pharmacology.
Kempegowda Institute Of Medical Sciences.
 Department of Pharmacology, Kempegowda Institute of Medical
Sciences, Banashankari 2ND stage, Bangalore.
KARNATAKA
560070
India

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9880052054

drpundarikahp@gmail.com
Source of Monetary or Material Support

Primary Sponsor Details

Dr Manjunatha R
Department of Pharmacology, Kempegowda Institute of Medical
Sciences, Banashankari 2ND stage, Bangalore 560070.
Other [self]
Address
NIL

Name of Site Site Address Phone/Fax/Email

Kempegowda Institute Department of Urology, 8951155519

of Medical Sciences Kempegowda Institute manjunatha5ramaiah@
Hospital and Research of Medical Sciences gmail.com
Centre Hospital and Research
centre, V V Puram,
Bangalore 560004.
Bangalore
KARNATAKA

Approval Status Date of Approval Is Independent Ethics

Committee?
Approved 02/09/2013 No
Date
No Date Specified
Condition
Patients of benign prostatic hyperplasia between
the age of 45 to 90 years who are otherwise
maintaining a good general health.
 Patients of benign prostatic hyperplasia between
the age of 45 to 90 years who are otherwise
maintaining a good general health.

Name Details
Alfuzosin Oral, 10mg OD for 3 months
Tamsulosin Oral, 0.4mg OD for 3 months.
Silodosin Oral, 8mg OD for 3 months.
Inclusion Criteria
45.00 Year(s)
90.00 Year(s)
Male
•Male subjects ? 45 years with BPH and associated lower urinary
tract symptoms (LUTS).<br/> •International prostate symptom score
(IPSS) ? 8<br/> •Quality of life score (QLS) ? 3<br/> •Maximum flow
rate (Qmax) < 15ml/s but > 4ml/s with a voided volume of >100
ml<br/> •Willingness to give written informed consent and to comply
with the study procedure, and available for regular follow up.<br/>

Exclusion Criteria
•Patients already on 5 ? reductase inhibitors

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•Severe hepatic or renal insufficiency

•Patients concomitantly receiving strong CYP3A4 inhibitors
•Urinary tract infections
•Urethral stricture
•Neurogenic bladder
•PSA ? 5ng/ml
•History of urethral or prostatic operation
•Likely to need catheterization within next 3 months
•Hypotension or severe untreated hypertension
•History of oesophageal or intestinal obstruction
•Patients receiving the drugs that may interfere with the response to
study medications, within previous 6 months like verapamil,
androgens, anti androgens, diuretics, cholinergics, anticholinergics,
phytotherapy
•History of alcohol or drug abuse
•Currently suffering from serious disease or malignancy
•Significant psychiatric problems
•Patients at increased risk of QTc prolongation
Outcome Timepoints
Baseline, 2 weeks, 4 weeks, 8 weeks and 12
weeks.

Outcome Timepoints
Not applicable

ble only for Completed/Terminated trials

ble only for Completed/Terminated trials

Need for study:

Several pharmacoeconomic studies have evaluated the use of
1
? blockers in the treatment of BPH. The overall cost-effectiveness for the different medications may vary depending on individual patient characteristics and comorbid

Pharmacoeconomic analyses of new treatment options for BPH may be useful in view of the increased
conditions.

attention being placed on treatment costs and the increasing incidence of BPH. Since several established
treatments for BPH are available (each with a different mechanism of action, effectiveness rate, safety profile,

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cost-effectiveness analyses can help to quantify potential advantages of

choices. As there are no studies in the Indian population
zosin, tamsulosin and silodosin in the management of BPH, the present
 page 4 / 4

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 :- Sun, 08 Jan 2023 05:02:24 GMT)

rial Registered Prospectively

dren Aged 6 To 17 Years With Bladder

te The Safety And Efficacy Of Fesoterodine

etrusor Overactivity Associated With A
vity)
Identifier
Amendment 5, 3 March 2014 Protocol Number
ClinicalTrials.gov
Details of Principal Investigator

Details Contact Person (Scientific Query)

Dr Karan Thakkar
Site Oversight and Operations Relationship Lead
Pfizer Limited
Pfizer Limited The Capital, 1802/1901, Plot No. C - 70, G Block,
Bandra Kurla Complex, Bandra (East), Mumbai - 400051, India.
Mumbai MAHARASHTRA 400051 India
Mumbai
MAHARASHTRA
400051
India

91-7045788858
91-22-265225993
Karan.Thakkar@pfizer.com
Details Contact Person (Public Query)
Dr Seema Pai
Director - Site Oversight and Operations Relationship Lead
Pfizer Limited
 Pfizer Limited The Capital, 1802/1901, Plot No. C - 70, G Block,
Bandra Kurla Complex, Bandra (East), Mumbai - 400051, India.
Mumbai MAHARASHTRA 400051 India
Mumbai
MAHARASHTRA

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400051
India
91-8826422322
91-22-265225993
seema.pai@pfizer.com
Source of Monetary or Material Support
17 USA
Primary Sponsor Details
Pfizer Inc
235 East 42nd Street, New York, NY 10017 USA
Pharmaceutical industry-Global
Address
Nil
Name of Site Site Address Phone/Fax/Email

Christian Medical Christian Medical 0161-5026999

College - Ludhiana College, Ludhiana - 0161-2228780
141008 Punjab, India drjchhatwal@gmail.
Ludhiana
PUNJAB

Dr. Ram Manohar Lohia Room no. 31, OPD 011-23361228

Hospital & PGIMER Block, Ground Floor , 91-11-23360067

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OPD Building, Baba drsoodr@yahoo.com

Kharag Singh Marg-110
001
New Delhi
DELHI
Inamdar Multispeciality Department of Urology, 00919822059799
Hospital - Pune Survey Number 15, 00912026055094
Fathimanagar - rajendrakshimpi@gmail
Wanwadi, Behind .com
KPCT Mall, Pune –
411040, Maharashtra,
India
Pune
MAHARASHTRA

King Georges Medical Department of Urology, 0091983918146

University - Lucknow King Georges Medical 0091522225654
University, Chowk, drapul.goel@gmail.
Lucknow – 226003,
Uttar Pradesh, India
Lucknow
UTTAR PRADESH

Approval Status Date of Approval Is Independent Ethics

Committee?
Approval Status Date of Approval Is Independent Ethics
Committee?
Approved 13/02/2017 No

Approved 29/06/2017 No

Approved 19/01/2018 No

Approved 28/04/2017 No

Date
03/09/2013
Condition
Bladder dysfunction due to a problem with the
nervous system leading to neurogenic detrusor

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overactivity.
Name Details
Fesoterodine 2 mg BIC Fesoterodine 2 mg BIC
(Beads-In-Capsule) (Beads-In-Capsule) once daily
for 24 weeks
 Fesoterodine 4mg BIC Fesoterodine 4mg BIC
(Beads-In-Capsule) (Beads-In-Capsule) once daily
for 24 weeks, with the first week
being 2mg BIC
(Beads-In-Capsule) once daily

Inclusion Criteria
6.00 Year(s)
17.00 Year(s)
Both
• Male or female subjects aged 6-17 years 11 months <br/> •
Subjects with stable neurological disease and neurogenic detrusor
overactivity <br/> • Evidence of a personally signed and dated
informed consent document In addition, an assent from the subject
will be obtained when appropriate, and when the potential subject is
capable of providing assent.

Exclusion Criteria
• Concomitant medications which may increase the risk to subjects
or confound study results
• Other medical conditions which may increase the risk to subjects
or confound study results
• Contraindications to the use of fesoterodine or oxybutynin

Outcome Timepoints
12 weeks time frame
Outcome Timepoints
maximum bladder capacity. 12 weeks time frame
12 weeks time frame

12 weeks time frame

12 weeks time frame

12 weeks time frame

12 weeks time frame

12 weeks time frame
12 weeks time frame

ble only for Completed/Terminated trials

ble only for Completed/Terminated trials
 PDF of Trial
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the medicine fesoterodine is a

muscle overactivity caused by a
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:- Sun, 08 Jan 2023 05:02:38 GMT)

rial Registered Retrospectively

dney functions in patients undergoing living

enal allograft outcome in patients undergoing

udy
Identifier
NIL
Details of Principal Investigator
Dr Divya Srivastava
Senior Resident
Sanjay Ghandhi Post Graduate Institute, Lucknow
MRA A16, SGPGI, Lucknow Dept of Anaesthesiology, A- block,
SGPGI, Rae Bareilly road Lucknow
Lucknow
UTTAR PRADESH
226014
India

8004904439

dr.divshri@gmail.com
Details Contact Person (Scientific Query)
Dr Sandeep Sahu
Associate Professor
Sanjay Ganghi Post Graduate Institute, Lucknow.
Dept of Anaesthesiology, A-block, SGPGI, Rae Bareilly road
Lucknow
Lucknow
UTTAR PRADESH
226014
India

8004904598

drsandeepsahu@yahoo.co.in
Details Contact Person (Public Query)
DrDivya Srivastava
Senior Resident
Sanjay Gandhi Post Graduate Institute, Lucknow
 Dept of Anaesthesiology, A-block, SGPGI, Rae Bareilly road
Lucknow
Lucknow
UTTAR PRADESH
226014
India

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8004904439

dr.divshri@gmail.com
Source of Monetary or Material Support

Primary Sponsor Details

SGPGI
Rae Bareilly Road, Lucknow
Research institution and hospital
Address
NIL

Name of Site Site Address Phone/Fax/Email

Urology Operation Urology OT, OT 8004904439

Theatre Complex, Block F, dr.divshri@gmail.com
SGPGI, Raebareli Road
Lucknow
Lucknow
UTTAR PRADESH

Approval Status Date of Approval Is Independent Ethics

Committee?
Approved 01/08/2013 No

Date
No Date Specified
Condition
End Stage Renal Disease patients undergoing
Renal Transplant Surgery.
 Medical and Surgical
Name Details
Moderate fluid administration Intraoperative fluid
administration before allograft
reperfusion @ 12-15ml/kg/hr,
CVP targeted between
6-8mmHg.

High fluid administration Old data of post renal transplant

patients. Patients recieved high
intraoperative fluid
administration @ 22-25ml/kg/hr,
CVP targeted between 12-15
mmHg

Inclusion Criteria
18.00 Year(s)
70.00 Year(s)
Both
> 18yrs,<br/> Undergoing living donor renal transplantation<br/>
Exclusion Criteria

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Consent not given

Outcome Timepoints
Intraoperative period till 6 months thereafter.

Outcome Timepoints
Post operative period till 10th day.

Post operative period till 10th day.

ation seen in patients of ESRD is cardiovascular dysfunction. Dialated cardiomyopathy,
of these patients also have minimal or low renal output making them highly vulnerable to features of
a common practice to infuse large volume of fluids to these patients in the intraoperative phase. The
mmHg 3 at the time of reperfusion of the transplanted kidney. However this approach also subjects
l showed that such aggressive approach for fluid management is not actually required and the renal
for adequate renal outcome without facing problems of volume overload. Similarly Campos et al 5
risk of chronic allograft dysfunction. They showed two fold greater risk of chronic renal dysfunction in

unctioning of renal allograft as did the previous approach of excess fluid administration. This
ion in previously cardiovascular compromised individuals.
ths. The intraoperative fluid management would be less than 15 ml/kg/hr and CVP maintained in
at judicious intraoperative fluid therapy alone (while maintaining the mean arterial pressures) will not

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ntraoperative fluid
function in the immediate post
atively.
nction in immediate post operative period till

delayed graft function, post operative

rement of dialysis in post operative
ompare it with previous year’s data.

donor renal transplant surgery at our institute for 6months.

take part in the study.

anesthesia, paralyzed, intubated and put

pattern. Patient controlled epidural
epidural catheter placed before
rterial blood pressures (ABP) and central
monitored. Patients will be extubated at
transplant unit (KTU) for further

patients are to be given fluid @

omosis is complete following which urine
fluid intake. The target CVP at the
 page 4 / 6

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between 6- 10 mmhg. The total fluid given

reperfusion of neo kidney. The total fluid
requirement of blood products and colloids
. All patients are to be given mannitol infusion in
reperfusion. The Mean arterial pressure
Hg at the time of clamp opening. 6 mg
phentermine will be used to overcome temporary

undergo nephrectomy under general

normal saline and 1500 mL Ringer
stalloid titrated to match the urine output
ery until the renal vessels are clamped. They will
g/kg 20 minutes before renal vessel

pressure (CVP); systolic, diastolic, and mean arterial blood pressure (MAP) will be recorded after induction, at the time of applying clamp and at
a) and after completion of surgery. Fluids administered including fresh frozen plasma (FFP), human albumin, and whole blood transfusions, renal
ill end of surgery will be recorded. The parameters of renal graft function including immediate diuresis; serum creatinine levels at day 0, 1, 2 4,7
be recorded. Episodes of acute graft rejection (ARE), acute tubular necrosis, requirement of hemodialysis and chronic graft dysfunction are to be

will be noted.

operated between june 2011 and may 2012 will be collected in the same proforma as above via use of Hospital administration system and old
actice of the then anaesthesiologist to administer high volumes of fluid 22-25ml/kh/hr in the intraoperative period. CVP was invariably kept above
998; 12: 511–517.

page 5 / 6

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ation during anesthesia increases pulmonary arterial pressures and improves early function of human renal transplants. Transplantation. 1982

A.Perioperative fluid management in kidney transplantation: is volume overload still mandatory for graft function?. Transplant Proc. 2006

emodynamic Factors of the Recipient Influence Renal Graft Function? Transplantation Proceedings 2012.Volume 44, Issue 6 ,1800-03.

f 07 Classification of Renal Allograft Pathology: Updates and Future Directions. American Journal of Transplantation 2008; 8: 753–760.
 page 6 / 6

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:- Sun, 08 Jan 2023 05:02:45 GMT)

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omidine and esmolol on patients
urological surgeries.
esmolol on hemodynamic attenuation and
going laproscopic urological surgeries
Identifier
NIL
Details of Principal Investigator
Dr Divya Srivastava
Senior Resident
Sanjay Gandhi Post Graduate Institute, Lucknow.
Dept. of Anesthesiology, Block A, SGPGIMS, Raebareli Road,
Lucknow.
Lucknow
UTTAR PRADESH
226014
India

8004904439

dr.divshri@gmail.com
Details Contact Person (Scientific Query)
Dr Sandeep Sahu
Associate Proffesor
Sanjay Gandhi Post Graduate Institute, Lucknow.
Dept. of Anesthesiology, Block A, SGPGIMS, Raebareli Road,
Lucknow
Lucknow
UTTAR PRADESH
226014
India

8004904598

drsandeepsahu@yahoo.co.in
Details Contact Person (Public Query)
Dr Divya Srivastava
Senior Resident
Sanjay Gandhi Post Graduate Institute, Lucknow.
Dept. of Anesthesiology, Block A, SGPGIMS, Raebareli Road,
Lucknow
Lucknow
UTTAR PRADESH
226014
India
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dr.divshri@gmail.com
Source of Monetary or Material Support

Primary Sponsor Details

SGPGI
Raebarelli road, Lucknow
Research institution and hospital
Address
NIL

Name of Site Site Address Phone/Fax/Email

Urology Operation OT Complex, Block F, 8004904439

Theatre SGPGIMS, Lucknow dr.divshri@gmail.com
Lucknow
UTTAR PRADESH

Approval Status Date of Approval Is Independent Ethics

Committee?
Approved 01/08/2013 No

Date
No Date Specified
Condition
Medical and Surgical
Medical and Surgical
Patients udergoing laparoscopic urological
surgeries

Name Details
Dexmedetomidine infusion. Induction with 1ug/kg over 15
mins, then 0.5ug/kg/hr,
intravenously during
intraoperative period.
 Esmolol infusion Induction with 1mg/kg over 10
min then infusion of
15ug/kg/min, intravenously
during intraoperative period.

Inclusion Criteria
18.00 Year(s)
70.00 Year(s)
Both
Patients undergoing laparoscopic urological procedures.<br/>
Surgeries to be included: Laparoscopic donor nephrectomy, lap
simple nephrectomies, and lap pyeloplasty.<br/>

Exclusion Criteria
1.Consent not given.
2.ASA physical status III and more,

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3.History of hepatic, renal, or cardiac failure, organ transplant,

4.History of diabetes, morbid obesity (body mass index > 40),
5.Chronic use of opioids or ß adrenergic receptor antagonists,
6.Known asthma or reactive airway disease,
7.Severe mental impairment,
8.Allergy to any of two drugs, or
9.Inability to comprehend pain assessment.

Outcome Timepoints
During intraoperative period.
24 hrs postoperatively

Outcome Timepoints
Immediately after operation

Immediate postopaerative period till 24hrs

postoperatively
 Intraoperative and 24hrs postoperatively

increase anesthetic depths to supranormal levels or take help of vasodilator drugs or anesthetic adjuvants. Both
molol is ultra short acting ß blocker. Use of both of these drugs has never been described for laparoscopic
ogical surgeries.

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ic urological surgeries. All the patients will receive balanced general anesthesia with endotracheal intubation and mechanical ventilation in similar pattern as per
by keeping Bispectral Index(BIS) <60 at all times. Injection atropine 0.03 mg bolus will be given for bradycardia and injection mephentermine 6mg bolus for

ery patient will be extubated and shifted to post op recovery room.

intubation , on starting drug, at CO2 insufflations, then every 15 mins, at stopping drug, at extubation and in post operative. Duration of surgery, total fentanyl

equirement of antiemetic in post operative will be studied.

three parameters of primary objective viz;

operative requirement of fentanyl in the
fentanyl used is used for sample size
ance level ? = 0 and power of the test as
on of 75 ug in the variable total fentanyl required and
taken as 50 ug, the number of cases per

ine as an anesthetic adjuvant in

ational study using entropy monitoring. J
; 28(3): 334–338

kanen I, et al. Effects of esmolol on hemodynamic

for laparoscopic surgery. Acta Anaesthiol

FranciscoJ et al Intraoperative Esmolol Infusion in

page 4 / 5

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operative Fentanyl in Patients Undergoing
omy Anesth Analg 2007;105:1255–62.

JP, Maze M: Effects of intravenous

modynamic changes Anesthesiology 1992; 77:
page 5 / 5

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:- Sun, 08 Jan 2023 05:02:51 GMT)

rial Registered Retrospectively

fferent techniques- Flexible cystoscope and

eJ stent removal using Flexible cystoscope

Identifier
NIL
Details of Principal Investigator
Dr Neeraj Agrawal
Senior Resident
JIPMER
Department of Urology, JIPMER, Puducherry 605006
Pondicherry
PONDICHERRY
605006
India

neeraj_agrus@yahoo.com
Details Contact Person (Scientific Query)
Dr R Manikandan
Assistant proffessor
JIPMER
Department of Urology, JIPMER, Puducherry 605006
Pondicherry
PONDICHERRY
605006
India

minks_77@rediffmail.com
Details Contact Person (Public Query)
Dr Neeraj Agrawal
Senior Resident
JIPMER
 H NO 23 OLD MSR, JIPMER, Puducherry 605006
PONDICHERRY
605006
India

neeraj_agrus@yahoo.com

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Source of Monetary or Material Support

Primary Sponsor Details

Jawaharlal Institute of Postgraduate Medical Education and
Research
dhanvantri nagar, puducherry
Research institution and hospital
Address
NIL

Name of Site Site Address Phone/Fax/Email

Department of Urology, JIPMER, dhanvantri 9488516897

3rd floor, SSB nagar, puducherry neeraj_agrus@yahoo.c
Pondicherry om
PONDICHERRY

Approval Status Date of Approval Is Independent Ethics

Committee?
Approved 06/06/2013 No

Date
No Date Specified
Condition
All adult patients 18 yrs and above with unilateral
DJS in situ for 2 to 6 weeks, due for stent
removal

Name Details
 Semirigid Ureteroscope Dj stent will be removed using
Semirigid Ureteroscope under
local anaesthesia after
instillation of 10ml of 2%
lignocaine jelly. Time and
operative difficulty during
procedure will be noted. After
the procedure, patient will be
asked to score his pain on VAS
from 1 to 10

Flexible Cystoscope Dj stent will be removed using

Flexible cystoscope under local
anaesthesia after instillation of
10ml of 2% lignocaine jelly.
Time and operative difficulty
during procedure will be noted.
After the procedure, patient will
be asked to score his pain on
VAS from 1 to 10. all the
parameters will be compared to
those of semirigid ureteroscope.

Inclusion Criteria
18.00 Year(s)

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60.00 Year(s)
Both
All adult patients 18 yrs and above with unilateral DJ stent in situ for
2-6 weeks, due for Dj stent removal

Exclusion Criteria
Migrated stents, Severe comorbidities, encrusted stents, Post renal
transplant, Residual or bilateral stent

Outcome Timepoints
during and at the end of procedure
Outcome Timepoints
during the procedure
ble only for Completed/Terminated trials
ble only for Completed/Terminated trials

nt) which are placed for various

PCNL, pyeloplasty, ESWL are an
s are usually removed after 2 to 6
Rigid cystoscope which were used
ort and pain, especially in male
udies had compared flexible and
rt and pain but for cystoscopy only
toscopy(FC) is associated with high
ping nation like ours cost
ed semirigid ureteroscope(SRU) for
nd female patients and found it
cost.
ent techniques for stent retrieval in

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e regarding the best technique, so we

aring flexible cystoscope and semierigid
 page 4 / 4

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:- Sun, 08 Jan 2023 05:02:56 GMT)

rial Registered Retrospectively

does relief of obstruction improves function.

unctioning obstructed kidney?

Identifier
NIL
Details of Principal Investigator
Sidhartha Kalra
Senior resident
jipmer
Department Of urology SS block Jipmer
Pondicherry
PONDICHERRY
605006
India

9500674381

sid6121984@yahoo.co.in
Details Contact Person (Scientific Query)
Dr K Murganandham
Associate Professor
jipmer
Department Of urology SS block Jipmer
Pondicherry
PONDICHERRY
605006
India

9952014597

anand78_uro@yahoo.co.in
Details Contact Person (Public Query)
Sidhartha Kalra
Senior resident
 jipmer
Department Of urology SS block Jipmer
PONDICHERRY
605006
India

9500674381

sid6121984@yahoo.co.in

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Source of Monetary or Material Support

Primary Sponsor Details

Jipmer
Jipmer Dhanvantari nagar Puducherry 605006
Research institution and hospital
Address
NIL

Name of Site Site Address Phone/Fax/Email

Department OF Urology 3rd floor SS Block 9500674381

Jipmer puducherry sid6121984@yahoo.co.
Pondicherry in
PONDICHERRY

Approval Status Date of Approval Is Independent Ethics

Committee?
Approved 28/02/2013 Yes

Date
No Date Specified
Condition
Patients having unilateral obstructed kidney with
split function less than 20 % with normal
functioning opposite kidney

Name Details
 Name Details
Ultrasound guided Patients included in the study
percutaneous nephrostomy will undergo Ultrasound guided
percutaneous nephrostomy
after informed consent.
Diethylene-triamine-penta-aceti Study participant will undergo
c acid (DTPA) scan and DTPA scan before and after
Creatinine clearance Percutaneous nephrostomy and
creatinine clearance of the
drained kidney will be assessed
at 6 weeks.

Inclusion Criteria
15.00 Year(s)
65.00 Year(s)
Both
Patients of age 15 to 65 with unilateral obstructed poorly functioning
kidney with split function less than 20%

Exclusion Criteria
- Bilateral obstruction
- Obstruction in Solitary kidneys
- Pyonephrotic kidneys
- Malignant obstruction
- Deranged renal functions

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Outcome Timepoints
6 weeks

Outcome Timepoints
6 weeks

ble only for Completed/Terminated trials

ble only for Completed/Terminated trials
ble only for Completed/Terminated trials
ble only for Completed/Terminated trials

pmer with Unilaterally obstructed kidney with

-triamine- penta acetic acid( DTPA )scan and
study.
USG) guided percutaneous
peat functional assesment will be done after
(CRCl) method.
merular function (GFR) estimated by CRCL
ssesed.

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rial Registered Prospectively

rial Registered Prospectively

n three formulations of Leuprolide Acetate

rence formulation of Takeda Pharma) in

ment, Parallel, Single-Dose Clinical

etate 11.25 mg (Luphere Depot®)-Test 1 (T1)
Test 2 (T2) of Daewoong Pharmaceuticals
mg (Lucrin Depot®) – Reference (R) of
tic Carcinoma Subjects Undergoing Initial

Identifier
Protocol Number

Details of Principal Investigator

Dr Subhra Lahiri
Associate Vice President
AXIS Clinicals Ltd
1-121/1 Miyapur
Hyderabad
ANDHRA PRADESH
500049
India

914040408064
914040408060
Subhra.L@axisclinicals.com
Details Contact Person (Scientific Query)
Dr Subhra Lahiri
Associate Vice President
AXIS Clinicals Ltd
1-121/1 Miyapur
Hyderabad
ANDHRA PRADESH
500049
India

914040408064
914040408060
Subhra.L@axisclinicals.com
Details Contact Person (Public Query)
Monika Sharma
Team Lead
AXIS Clinicals Ltd
 1-121/1 Miyapur
Hyderabad
ANDHRA PRADESH

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500049
India
914040408270
914040408060
monika.s@axisclinicals.com
Source of Monetary or Material Support
-Ri, Pogok Eup, Cheoin Gu Yongin, Kyunggi

Primary Sponsor Details

Daewoong Pharmaceuticals Co Ltd
501-2, Samgye-Ri, Pogok Eup, Cheoin Gu Yongin, Kyunggi Do-
449-814, South Korea.
Pharmaceutical industry-Global
Address
501-2, Samgye-Ri, Pogok Eup, Cheoin Gu
Yongin, Kyunggi Do- 449-814, South Korea.

Name of Site Site Address Phone/Fax/Email

AXON Hospital Department of 914044505555

Radio-Oncology, AXON drdoddala@gmail.com
Hospital, Opposite
ICICI Bank SR Nagar
Ameerpet Main Road
Hyderabad
ANDHRA PRADESH

Body Line Hospitals Pvt Opp Annapurna Hall 919824035673

Ltd Beside Dev Status New 07926641658
Vikas Gruh Road Paldi shaileshshahuro@yaho
Ahmedabad 380007 o.com
Ahmadabad
GUJARAT
Christian Medical Department of Urology 911612600685
College Ludhiana kjmammen@gmail.com
Ludhiana
PUNJAB

Excel hospital Deapartment of 912612236036

Urology, 8-15, 3rd kapilthakkar@gmail.co
Floor, Sheetal stopping m
Swuare (Old LB
Cinema), ghod-dod
Bhattar road junction
Surat
GUJARAT

Gurushree Hi-Tech No 1558 Opp Chandra 919945813327

Multi Speciality Hospital Layout Bus Stand 918023394781
Chandra Layout muralis_14@yahoo.co
Vijaynagar Bangalore m
560 040
Bangalore
KARNATAKA

Manu Hospital and A 1 Shyam Nagar 919829064940

Research Centre Sodala Jaipur 302019 01412293800

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Jaipur dr_raviagrawal@rediffm
RAJASTHAN ail.com
NRR Hospital Department of 918028374115
Oncology, NRR dryathish@hotmail.com
Hospital, Near
Janapriya apartment
chikkasandra(Near
Chikkabanavara
Railway Station)
Hesargatta main road
Bangalore
KARNATAKA

Rajiv Gandhi Cancer Consulting room no 911147022027

Institute and Research 2058 B Block Old dr_rawal@hotmail.com
Centre Building Sector 5 Rohini
West
DELHI
Sanjay Gandhi Post Department of Urology 915222494137
Graduate Institute of and renal anilpall@yahoo.com
Medical Sciences transplantation, Sanjay
Gandhi Post Graduate
Institute of Medical
Sciences Raebareli
Road, Luknow-226014
Uttarpradesh, India
Lucknow
UTTAR PRADESH

Srinivasam Cancer No- 236/1 , Vijayashree 919448055949

Care Hospital Layout , Arekere, 08042099074
Bannerghatta Main kcluck@gmail.com
Road, Bangalore
-560072
Bangalore
KARNATAKA

Approval Status Date of Approval Is Independent Ethics

Committee?
Approved 30/12/2013 No

Approved 16/08/2014 No

Approved 21/07/2014 Yes

Approved 29/12/2013 No

Approved 19/02/2014 No

Approved 21/08/2014 No

Approved 12/02/2015 No

Approved 21/01/2014 No

Approved 16/08/2014 No

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Date
05/09/2014
 05/09/2014
Condition
Prostate carcinoma
Name Details
Luphere Depot(Leuprolide Subcutaneous 3 month depot
11.25 mg injection)-Batch 1
Luphere Depot (Leuprolide Subcutaneous 3 month depot
11.25 mg injection)-Batch 2
Lucrin Depot(Leuprolide 11.25 Subcutaneous 3 month depot
mg)

Inclusion Criteria
45.00 Year(s)
65.00 Year(s)
Male
1. Male subjects with body mass index (BMI) between 18 and
30kg/m2 (inclusive) and aged between 45 and 75 years (both
inclusive) with histologically confirmed carcinoma of prostate
undergoing initial therapy with Leuprolide acetate 11.25mg 3 months
depot preparation.<br/> 2. Testosterone levels ?1.5ng/mL at
screening.<br/> 3. WHO ECOG performance status between 0 and 2
(inclusive) and an expected survival of ? 12months .<br/> 4. Subjects
having adequate hematologic reserve at screening as per principal
investigator/sub investigator assessment.<br/> 5. Subjects having
adequate and stable hepatic function and renal function at screening
as per principal investigator/sub investigator assessment.<br/> 6.
Subjects having normal ECG, chest X-ray (PA view) and spinal X-ray
(Lateral view).<br/> 7. No intake of any medicinal preparations,
rendering expressed influence on hemodynamic, liver functions etc
(e.g., barbiturate, omeprazole, cimetidine etc.) Less than for 30 days
prior to the study check-in.<br/> 8. No history of dehydration from
diarrhea, vomiting or any other reason within a period of 24 hours
prior to study check-in.<br/> 9. Negative results for drugs of abuse in
urine during the day of study check-in.<br/> 10. Negative alcohol
breath analysis during the study check-in.<br/> 11. Subject should
have given written informed consent to participate in the study.<br/>
12. Subjects having ability to comprehend the full nature and
purpose of the study, including possible risks and adverse events;
ability to co-operate with the Investigator and to comply with the
requirements of the entire study.<br/> <br/>

Exclusion Criteria
1. Evidence of severe urinary tract obstruction with anticipated
urinary retention, in the opinion of the Investigator, taking into
account medical history, clinical observations and symptoms.
2. History of chronic fatigue or worsening general health.
3. History of osteoporosis or bone pains.
4. History of tobacco ( 9 cigarettes/beedies per day) or alcohol abuse
within past 3 months of screening.
5. History of intake of anticonvulsants and corticosteroids or any
other drug known to decrease bone density.
6. History or evidence of thrombophlebitis, thromboembolic
disorders, cerebral apoplexy.
7. Excruciating, severe bone pain which is due to from extensive
metastatic osseous deposits (in the opinion of the Investigator),
taking into account medical history, clinical observations and
symptoms.

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8. Evidence of brain metastases, taking into account medical history,
clinical observations and symptoms (as decided by the investigator).
9. History of systemic therapy for cancer such as chemotherapy,
radiotherapy or immunotherapy (e.g., antibody therapies,
tumor-vaccines), biological response modifiers (e.g., cytokines)
within 3 months of screening or previous local therapy to the primary
tumor (external beam radiotherapy, brachytherapy, thermotherapy,
cryotherapy).
10. History of prostatic surgery (e.g., radical prostatectomy,
transurethral resection of the prostate [TUR-P]) or orchiectomy,
adrenalectomy or hypophysectomy.
11. Intake of any investigational drugs within 5 half-lives of its
physiological action or 3 months (whichever is longer) before
screening.
12. Previous treatment with AR-receptor blockers, such as
Casodex®, Fugerel®, Megace®, Androcur® (no wash-out allowed)
or 5-?-reductase inhibitors (Proscar®, Avodart®, Propecia®) or
Over-the-counter (OTC) or alternative medical therapies which have
an estrogenic or anti-androgenic effect (i.e., PC-SPES, saw
palmetto, Glycyrrhiza®, Urinozinc®, DHEA) within the 3 months
before screening .
13. Administration of hormonal therapy, including GnRH analogs
(except Leuprolide acetate 11.25 mg 3 months depot preparation)
(less than or equal to 6 month depot administration), estrogen,
megace and phytotherapy, within 32 weeks prior to the screening
visit and during the study.
14. History of uncontrolled diabetes mellitus.
15. History of blood donations/losses within 3 months of screening.
16. Subjects with known hypersensitivity to GnRH, GnRH agonist,
including any LHRH analogues, or any excipients of the study
formulation.
17. History of any coagulation or bleeding abnormality
18. History of venous thrombosis within 6 months prior to baseline.
19. Significant Pre-existing co-morbidities
a. Cardiovascular
• Myocardial infarction within the last 6 months
• Congestive heart failure
• Unstable angina
• Active cardiomyopathy
• Cardiac arrhythmia
• Uncontrolled hypertension
• History of familial long QT syndrome or sudden cardiac death
b. Pulmonary
• Pulmonary disease requiring oxygen
c. Neurologic and psychiatric
• History of significant neurologic or psychiatric disorder that would
preclude study compliance or ability to give informed consent.
d. Gastrointestinal (GI)
• GI conditions that would preclude compliance with oral medication
e. Other cancer(s)
• Other malignancy than carcinoma of prostate within the past 5
years.
20. Subjects positive for HIV 1 & 2/HBsAg/HCV at screening.
21. Any deviation from a normal diet e.g. religious fasting.
22. Consumption of grape fruit juice within the 48 hours prior to study
check-in.
23. High caffeine (more than 5 cups of coffee or tea/day).
24. History of any disorder that interferes with the blood sampling
during the study.
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Outcome Timepoints
• Day1,3,7,14,21,28,35 and Day 42

Outcome Timepoints
Timepoint: Day1,3,7,14,21,28,35 and Day 42

hree-Treatment, Parallel, Single-Dose

olide Acetate 11.25 mg (Luphere
(Luphere Depot®) –Test 2 (T2) of Daewoong
de Acetate 11.25 mg (Lucrin Depot®) –
d., in Male Prostatic Carcinoma Subjects

quivalence of test drug (T1 & T2) with the

ective of the study is to monitor the adverse
y reported adverse events, laboratory, clinical
patients.
hree-Treatment, Parallel, Single-Dose
olide Acetate 11.25 mg (Luphere
(Luphere Depot®) –Test 2 (T2) of Daewoong
de Acetate 11.25 mg (Lucrin Depot®) –
d., in Male Prostatic Carcinoma Subjects

quivalence of test drug (T1 & T2) with the

ective of the study is to monitor the adverse
y reported adverse events, laboratory, clinical
patients.

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:- Sun, 08 Jan 2023 05:03:29 GMT)

rial Registered Prospectively

manufactured by Par Pharmaceutical,NY

Novartis Pharma Stein AG Stein, Switzerland
ing condition.
two period, two sequence, multiple-dose,
tablet once daily manufactured by Par
y, NY 10977,USA with Afinitor (Everolimus)
AG Stein, Switzerland and Distributed by:
New Jersey 07936 in Advanced Renal Cell
two period, two sequence, multiple-dose,
tablet once daily manufactured by Par
y, NY 10977,USA with Afinitor (Everolimus)
AG Stein, Switzerland and Distributed by:
New Jersey 07936 in Advanced Renal Cell

Identifier
Protocol Number

Details of Principal Investigator

Dr Brijesh Wadekar
Head of Department
Veeda Clinical Research Pvt. Ltd.
Veeda Clinical Research Pvt. Ltd.Insignia, Sindhu Bhavan Road,
Bodakdev Road, S.G.highway. Ahmedabad Ahmadabad GUJARAT
Ahmadabad GUJARAT
Ahmadabad
GUJARAT
380059
India

07930013001

brijesh.wadekar@veedacr.com
Details Contact Person (Scientific Query)
Dr Brijesh Wadekar
Head of Department
Veeda Clinical Research Pvt. Ltd.
Veeda Clinical Research Pvt. Ltd.Insignia, Sindhu Bhavan Road,
Bodakdev Road, S.G.highway. Ahmedabad Ahmadabad GUJARAT
Ahmadabad GUJARAT
GUJARAT
380059
India

07930013001

brijesh.wadekar@veedacr.com
Details Contact Person (Public Query)
Dr Brijesh Wadekar
Head of Department

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Veeda Clinical Research Pvt. Ltd.

 Veeda Clinical Research Pvt. Ltd.
Veeda Clinical Research Pvt. Ltd.Insignia, Sindhu Bhavan Road,
Bodakdev Road, S.G.highway. Ahmedabad Ahmadabad GUJARAT
Ahmadabad GUJARAT
GUJARAT
380059
India

07930013001

brijesh.wadekar@veedacr.com
Source of Monetary or Material Support

Primary Sponsor Details

Par PharmaceuticalInc
1 Ram Ridge Road, Spring Valley, NY 10977,USA
Pharmaceutical industry-Global
Address
Veeda clinical research Pvt. Ltd Shivalik Plaza,
Near I.I.M., Ambawadi, Ahmedabad 380 015,
India

Name of Site Site Address Phone/Fax/Email

Axon Hospital Axon Hospital,Third 9848050717

Floor, Clinical Research drdoddala@gmail.com
department, Ameerpet
road, Opposite ICICI
bank Hyderabad,
Andhra Pradesh -500
038
Hyderabad
ANDHRA PRADESH

City Cancer centre First Floor, Clinical 9885256059

Research Department, mgopichand@yahoo.co
33-25-33, Venkta m
Krishnayya street
suryaraopet,
Vijaywada-520002
Hyderabad
ANDHRA PRADESH
Srinivasam cancer care Fourth Floor, Clinical 9448055949
hospitals India Pvt Ltd Research Department, kcluck@gmail.com
No 236/1, Vijayashree
layout, Arekere,
Bennerghatta main
road, Bangalore,
560076
Bangalore
KARNATAKA

Mysore Medical College Department of radiation 9886873788

and Research Institute Oncology, Irwin Road, dal_muk@hotmail.com
Near Railway station,

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Mysore, 570001
Mysore
KARNATAKA
Department of Medical 9286220191
Oncology, No. 46 aurunonco@gmail.com
Singaralhope,
Trichy-620008, Tamil
Nadu, India
Tiruchirappalli
TAMIL NADU

Oncology OPD, Ground 9443337230

Floor, No. 27, Babu kns68@yahoo.com
Road, Trichy-620008,
Tamilnadu
Tiruchirappalli
TAMIL NADU

Erode Cancer Centre, 9842334222

Velavan Nagar, (Near velavandoctor@gmail.c
Chinthamani petrol om
punk) Thindal (PO),
Peruindurai Road,
Erode-638012
Erode
TAMIL NADU

Third Floor, Clinical 9242698750

Research Department, svhospitalresearch@g
No. 86 , Hosur Main mail.com
road, Madiwala,
Bangalore, 560068
Bangalore
KARNATAKA
Department of 9850246275
Radiation therapy and drkmkamble@yahoo.co
Oncology, Room No. .in
85, Vishwakarma
Nagar, Nagpur-440003,
Maharashtra, India
Nagpur
MAHARASHTRA

Department of General 9822102940

Surgery, 1st floor, Cromgoa@gmail.com
Caculo Enclave,
St.Inez, Panaji,
Goa-403001
South Goa
GOA

First Floor, Research 92215510913

Room No. 104, Plot No. drbamit.research@gmai
23, Opposite Karve l.com
Road, Erandawane,
Pune-411004
Pune
MAHARASHTRA

Urology Ofice, 9824028041

Dr.Virendra Desai mrdesai@mpuh.org
Road, Nadiad-387-001,
Gujarat, India
Kheda
GUJARAT

page 3 / 11

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Department of 9829057033
Radio-Oncology, J.L.N omshar_2005@yahoo.c
Marg, Jaipur- 302004 o.in
Jaipur
RAJASTHAN

Third Floor, Clinical 9246243024

Research, sureshattili@yahoo.com
16-3-991/1/c, Govt
Printing press road,
Malakpet, Hyderabad,
500024, AP, India
Hyderabad
ANDHRA PRADESH
Kidney Centre, 9823056120
Panchsheel Square, drravi1962@gmail.com
Wardha Road,
Nagpur-440012,
Maharashtra, India
Nagpur
MAHARASHTRA

Department of Urology, 9825097767

Asarwa, ketanshukla1968@gma
Ahmedabad-380016, il.com
Gujarat, India
Ahmadabad
GUJARAT

Department of Urology, 9414057088

J.L.N Marg, Jaipur- dr_v_tomar@yahoo.co.i
302004 n
Jaipur
RAJASTHAN

Ground Floor, Clinical 9823133390

Research Room,153, minishjain009@gmail.c
Magarpatta city road, om
Hadapsar, Pune
411013 Maharashtra ,
India
Pune
MAHARASHTRA

Clinical Research 9431021001

Room, Doctors Colony drjksingh147@hotmail.c
Malahi Parki Chowk, om
Kankar bagh, Patna,
Bihar-800020
Patna
BIHAR

Department of 9437031718
Radiation Oncology, snsenapati2007@gmail
Medical Road, .com
Mangalabag, Cuttac,
Odisha
Cuttack
ORISSA

Ground floor, Clinical 9823190192

Research Department, ajayonco@hotmail.com
11, Shankr Nagar, West
High Court, Nagpur,
440010 Maharastra
Nagpur

page 4 / 11

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MAHARASHTRA
Department of 9787713004
Oncology,Lake drkskk@yahoo.com
area,Merul road,
Madurai,Tamilnadu,
625107
Madurai
TAMIL NADU

HCG tower No. 4 , Fifth 9731209671

Floor,Room No. 512, drraghunathsk@yahoo.
Lane No. 8, P. Kalinga com
Rao road,
Sampangiram Nagar,
Bangalore – 560027,
Karnataka , India
Bangalore
KARNATAKA

Department of Surgery, 9225068540

Near Shashtri Nagar, kkulkarni.aacr@gmai.co
KMT Workshop, m
Kolhapur,
Maharashtra-416012
Kolhapur
MAHARASHTRA

Research Room, 9824035673

Ground Floor, Opp. shaileshshahuro@yaho
Anupama Hall, Near o.co.in
Dev Status, New Vikas
Gruh Road, Paldi,
Ahmedabad-380007,
Gujarat, India
Ahmadabad
GUJARAT

Department of Medical 9591970742

Oncology, Mazumdar Bharath37@gmail.com
Shaw Medical
Centre,NH Health City,
7th Floor 258/A
Bommasandra
Industrial Area Anekal
Taluk, Bangalore - 560
099, Karnataka, India
Bangalore
KARNATAKA

Departement of Medical 9840033512

Oncology, # 439, reanpv60@hotmail.com
Cheran nagar,
Perumbakkam,
Chennai - 600100
Chennai
TAMIL NADU
First Floor, Department 02026128219
of Surgery, Ward no. drkirankumarj@gmail.c
10, Sassoon Road, om
Somwar Peth, Pune, 41
1001, Maharashtra,
India
Pune
MAHARASHTRA

page 5 / 11

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Curie Manavata cancer Oncology OPD, Ground 9823061929

centre Floor,Opp:Mhamarg drraj@manavatacancer
Bus centre.com
Stand,Mumabi,Nasik, M
aharastara-422002,IND
IA.
Nashik
MAHARASHTRA

Maharastra Medical First Floor, Clinical 020-25676861

Foundation Joshi Research Department, drrakeshn@gmail.com
Hospital 778 opp. Kamala Nehru
park, Pune – 411004,
Maharastra India
Pune
MAHARASHTRA

Inamdar multispecialty Hospital Building 020-41236660

Hospital ,Basement, Research drtusharp@gmail.com
Room, S.No. 15 Fatima
nagar, Pune ,
Maharastra 411040,
India
Pune
MAHARASHTRA

Approval Status Date of Approval Is Independent Ethics

Committee?
Approved 10/02/2014 No

Approved 28/02/2014 No
Approved 27/01/2014 No

Submittted/Under No Date Specified No

Review

Approved 11/02/2014 No

Approved 16/01/2014 No

Approved 20/01/2014 No

Approved 18/01/2014 No

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CTRI Website URL - http://ctri.nic.in

01/02/2014 No

07/02/2014 No

01/02/2014 No
26/03/2014 No

No Date Specified No

No Date Specified No

03/02/2014 No

No Date Specified No

No Date Specified No

20/02/2014 No

01/03/2014 No

No Date Specified No

12/02/2014 No

page 7 / 11

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Approved 03/02/2014 No

Approved 29/01/2014 No

Approved 03/02/2014 No

Approved 31/01/2014 No

Submittted/Under No Date Specified No

Review

Approved 24/02/2014 No

Submittted/Under No Date Specified No

Review

Submittted/Under No Date Specified No

Review

Approved 09/04/2014 No

Approved 24/01/2014 No

Date
27/01/2014
Condition
Advance Renal cell carcinoma
Name Details
 Everolimus 10 mg tablet, Once Manufactured by Par
daily, Orally for 14 days Pharmaceutical, Inc. 1 Ram
Ridge Road, Spring Valley, NY
10977,USA
Afinitor (Everolimus) 10 mg Manufactured by: Novartis
tablet, Once daily, Orally for 14 Pharma Stein AG Stein,
days Switzerland and Distributed by:

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Novartis Pharmaceuticals
Corporation East Hanover, New
Jersey 07936

Inclusion Criteria
18.00 Year(s)
65.00 Year(s)
Both
1.Men and Women, of age in between 18 years to 65 years (both
inclusive).<br/> 2.Ability to provide informed consent prior to
participation in the study<br/> 3.Histologically or Cytologically
confirmed diagnosis of advanced renal cell carcinoma.<br/>
4.Women of childbearing potential must have a negative serum
pregnancy test in screening and negative urine pregnancy test on
day 0 and must be using an adequate method of contraception.<br/>
5.Patients with advanced renal cell carcinoma and who are already
receiving a stable dose of Everolimus tablets, 10 mg tablet once
daily.<br/> 6.Adequate organ function, defined as the following:<br/>
•Hemoglobin level ? 9 gm /dl <br/> •Total bilirubin < 1.5 x upper limit
of normal (ULN) <br/> •SGOT and SGPT < 2.5 x ULN <br/>
•Creatinine < 1.5 x ULN <br/> •Platelets > 100 x 10 raise to
nine/L<br/> •Clinically non significant fasting blood glucose
levels<br/> 7.No history of addiction to any recreational drug or drug
dependence<br/> 8.No participation in any clinical study within the
past 60 days prior to first dosing in the study.<br/> 9.ECOG
performance status of ? 2 on the ECOG scale <br/> 10.Clinically
acceptable ECG in opinion of the Investigator/Designee.

Exclusion Criteria
 1.A history of allergic or adverse reactions to Everolimus or any other
rapamycin derivative or any of its excipients
2.Patients with renal failure, or for whom the need for dose change
during the study can be anticipated, should be excluded.
3.Patient with active infection and symptoms of Non-infectious
pneumonitis (symptoms such as but not limited to hypoxia, pleural
effusion, cough, or dyspnea, and in whom infectious, neoplastic, and
other causes have been excluded by means of appropriate
investigations) as judged by the investigator.
4.Concurrent use of other drugs known to suppress bone marrow
function
5.Expected changes in concomitant medications during the period of
study
6.Positive tests for drug of abuse at baseline.
7.History of alcoholism / alcohol abuse.
8.Patients who are:
•Pregnant
•Breast feeding
•Of childbearing potential without a negative pregnancy test at
baseline
•Male or female of childbearing potential unwilling to use barrier
contraceptive precautions throughout the trial and at least 8 week
after ending study treatment.
9.Patient had major surgery within 4 weeks prior to study entry, or
who have not recovered from prior major surgery
10.Patients with known positivity for human immunodeficiency virus
(HIV), HBsAg and HCV.
11.Patients with any significant history of non-compliance to medical
regimens
12.History of difficulty with donating blood or difficulty in accessibility
of veins.
13.Patients for whom oral administration of drug is not possible.

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14.An unusual or abnormal diet, for whatever reason e.g. religious

fasting.
15.Patients having known brain metastasis
16.Donation of blood (1 unit or 350 ml) within 90 days prior to
receiving the first dose of investigational medicinal product in the
study.

Outcome Timepoints
Outcome Timepoints
The pre-dose blood sample of 3.0 mL (00.00) will
be collected within 5 minutes before dosing on
Day 12 and 14 of both periods. On day 14, the
post-dose blood samples of 3.0mL each will be
drawn at 0.25, 0.5,0.75, 1.0,2.5, 3.0, 4.0, 8.0,
12.0 and 24.0 hrs following drug administration
in each period.

Outcome Timepoints
Not Applicable

A Multicenter, randomized, open label, two treatment, two period, two sequence,
multiple-dose, cross-over, bioequivalence study of Everolimus 10 mg tablet once
daily manufactured by Par Pharmaceutical, Inc. 1 Ram Ridge Road, Spring
Valley, NY 10977,USA with Afinitor (Everolimus) 10 mg tablet manufactured
by: Novartis Pharma Stein AG Stein, Switzerland and Distributed by: Novartis
Pharmaceuticals Corporation East Hanover, New Jersey 07936 in Advanced Renal
Cell Carcinoma patients under fasting condition. Sufficient number of patients
will be enrolled to have 48 evaluable patients in the study . Total expected
duration of the study will be of at least 29 days from the day first IMP
administration in Period I till collection of last PK blood sample in period II i.e. on

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period of between two periods.
s will be collected during the study.
tient diary card to enter the details of study
will be provided with adequate
s/her home. Compliance for
patients diary for IMP consumption at
dispensed container on the appropriate section
. Patients who complete the study and are
ents immediately after the last IMP
n in period II. A telephonic safety
mized patients till 30 days after the last
page 11 / 11

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 :- Sun, 08 Jan 2023 05:03:41 GMT)

rial Registered Retrospectively

removing bladder tumours help in increasing

r cancer ?
ion of bladder tumour in transitional cell
ntrolled trial from a tertiary care centre in

Identifier
NIL
Details of Principal Investigator
Dr Partho Mukherjee
Mch. Urology Resident
Christian Medical College, Vellore
Department of Urology Christian Medical College, Vellore Tamil
Nadu – 632004 Phn No : 0416-2282055/2282111, Email :
parthonline1981@gmail.com
Vellore
TAMIL NADU
642004
India

09894786992

parthonline1981@gmail.com
Details Contact Person (Scientific Query)
Dr Antony Devasia
Mch. Urology Professor (GUIDE)
Christian Medical College, Vellore
Department of Urology,Unit I Christian Medical College, Vellore
Tamil Nadu – 632004 Phn No : 0416-2282055
Vellore
TAMIL NADU
632004
India

antonydevasia@cmcvellore.ac.in
Details Contact Person (Public Query)
Dr Partho Mukherjee
Mch. Urology Resident
Christian Medical College, Vellore
 Department of Urology Christian Medical College, Vellore Tamil
Nadu – 632004 Phn No : 0416-2282055/2282111, Email :
parthonline1981@gmail.com
Vellore
TAMIL NADU

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642004
India
09894786992

parthonline1981@gmail.com
Source of Monetary or Material Support

Primary Sponsor Details

Institutional Review Board Fluid research Grant
Office of Research Institutional Review Board(IRB) CHRISTIAN
MEDICAL COLLEGE, Vellore, India. Pin 632004 Phone 0416
2284294 Email : research@cmcvellore.ac.in
Research institution and hospital
Address

Name of Site Site Address Phone/Fax/Email

Christian Medical Department of urology, 09894786992

College, Vellore christian Medical parthonline1981@gmail
College, Vellore Tamil .com
Nadu - 632004
Vellore
TAMIL NADU

Approval Status Date of Approval Is Independent Ethics

Committee?
Approved 01/12/2013 No

Date
No Date Specified
Condition
 Condition
Transitional Cell Carcinoma Bladder
Name Details
Narrow band imaging (Olympus NBI, an optical image
system) enhancement technique, is
based on the fact that the depth
of light penetrating into the
urothelium increases with
increasing wavelength. Thus,
with NBI, the tissue surface is
illuminated with light of a narrow
bandwidth, with centre
wavelengths in the blue (415
nm) and green (540 nm) zone of
the electromagnetic spectrum.
These specific wavelengths are
strongly absorbed by
hemoglobin and vascular
(tumour and areas of CIS)

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structures appear dark brown or
green against a pink or white
mucosal background, without
the use of any dye. Narrow
band imaging has been used to
advantage in
gastroenterological endoscopic
studies. Its benefit in enhancing
the detection of bladder tumours
has also been reported. A
significantly higher overall tumor
detection rate was described for
NBI cystoscopy versus WLC
both in the literature (94.7%
versus 79.2% by Cauberg et al.
2010, ) and (94.8% versus
83.9% by Geavlete et al). From
the tumor stage point of view,
improved CIS (89.7% versus
50%) and pTa (98.7% versus
82.9%) detection rates were
described for NBI cystoscopy in
comparison to the standard
approach according to the
literature. For WLC and NBI
cystoscopy the overall
sensitivity was 87% and 100%
and the overall specificity 85%
and 82%, respectively. Another
study detected 100% versus
66.7% and 93.9% versus 87.85
detection rates for CIS and pTa
tumours respectively. Another
distinct advantage of NBI was to
give to the surgeon a much
clearer idea of the margin of the
tumor margins, due to the
improved visualization of the
surface layer. Interestingly,
following resection of tumour
under white light, grossly normal
margins, when viewed under
NBI revealed extended positive
tumoral margins in the normal
appearing mucosa surrounding
the tumors, confirmed by
pathology in 10.3% of NMIBC
cases. These advantages
conferred by the NBI system
have been purported to have a
direct bearing in reducing
tumour recurrence rate among
patients of non muscle invasive
bladder cancer by 10% at 1 yr.
Bladder cancer is a common
urological malignancy with an
incidence of over 60,000 cases
per year in the US. It is the 4th
most common cancer in men
and the 9th most common in
women. 55-60% of newly

page 3 / 6

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 diagnosed tumours are of low
grade and stage. The majority
of these patients will develop
recurrences usually also of low
grade. 40-45% of cancers are
high grade with about half of
these being muscle invasive.
Regardless of clinical stage, the
initial treatment of all bladder
tumours consists of a thorough
TURT with further treatment
tailored according to the
histopathological grade and
stage. The ideal method for
resection of a bladder tumour is
to resect first the bulk of the
tumours, and then the deep
portion along with some
underlying bladder muscle,
sending each specimen
separately for histologic
examination. This approach
usually enables complete
removal of the tumours and
provides valuable diagnostic
information about the grade and
depth of infiltration of the
tumours. This is most widely
done under white light. One of
the important factors which
cause recurrence among
bladder tumour patients is the
field change of the entire
transitional urothelium which
occurs on exposure to the
carcinogen. These cause a
continuum of changes in the
urothelium which ranges from
carcinoma in situ to small pTa
tumours to gross tumours.
During resection of bladder
tumours under white light, only
the gross tumours which are
clearly visible under white light
are resected, leaving behind
areas of diseased mucosa with
carcinoma in situ (CIS) not
clearly defined under WL, or
tumour too small to be detected
under white light. These can
form foci of future recurrence in
the bladder tumour. Hence, any
modality which can aid or
enhance the detection of these
additional tumours or foci of CIS
for resection is welcome.

Inclusion Criteria
 Inclusion Criteria
0.00 Day(s)
99.00 Year(s)
Both

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All patients who undergo Trans - urethral resection of bladder tumour

(TURBT) in CMC Vellore from August 2013 to December 2014. New
tumours and recurrent tumours (single or multiple tumours , largest
tumour less than or equal to 5 cms in size) will both be
included.<br/> Diagnosis of bladder tumours will be made on the
basis of cystoscopic <br/> findings, imaging Ultrasonography (USG),
Intravenous pyelogram (IVP) or <br/> Computerized tomography
(CT) or urine cytology.<br/> Patients should be fit for anesthesia as
decided by anesthetists.<br/>

Exclusion Criteria
Refused to consent
Size of tumour >5 cm
Other modality of treatment (Radiotherapy )
Not fit for anesthesia

Outcome Timepoints
The outcome will be assessed at the end of
recruitment of all the patients required to
complete the sample size (95 in each arm).

Outcome Timepoints
NIL

ble only for Completed/Terminated trials

ble only for Completed/Terminated trials
 pilation of data and results.
mon urological malignancy with an
in the US. The majority of these
also of low grade. One of the
e among bladder tumour patients

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itional urothelium which occurs on

white light (WL) cystoscopy has
ction and resection of these. This
ying tumour, more so for CIS. Narrow
ge in gastroenterological
ncing the detection of bladder
nificantly higher overall tumor
y versus WLC in the

control crossover trial comparing

ght assisted cystoscopy for trans-urethral
patients (in each arm) who are
r with single or multiple tumours (Largest
under WL , with excision of all
followed by removal of TURT chips
immediately followed by NBI cystoscopy
newly detected under NBI, thus effecting
will be done for the other arm.

tumour detection, as effected by the

will be individually studied NBI and
will be put to statistical tests of

dual purpose of defining the role

, and, if proven beneficial, paving its way
of bladder cancer in India

page 6 / 6

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:- Sun, 08 Jan 2023 05:03:59 GMT)

rial Registered Prospectively

al (silodosin) in Indian male patients with

al (silodosin) in Indian male patients with

g study to evaluate the efficacy and safety of

inary tract symptoms associated with benign

Identifier
Protocol Number
Details of Principal Investigator
Dr chetan Mehndiratta
Sr. Medical Advisor
sponsor representative
Ranbaxy Laboratories Ltd, Western Edge-I, Unit no. 201-204, 2nd
Floor, Western Express Highway, Borivali (E), Mumbai
Mumbai (Suburban)
MAHARASHTRA
400066
India

9920590710

Chetan.Mehndiratta@ranbaxy.com
Details Contact Person (Scientific Query)
Dr chetan Mehndiratta
Sr. Medical Advisor
sponsor representative
Ranbaxy Laboratories Ltd, Western Edge-I, Unit no. 201-204, 2nd
Floor, Western Express Highway, Borivali (E), Mumbai
Mumbai (Suburban)
MAHARASHTRA
400066
India

9920590710

Chetan.Mehndiratta@ranbaxy.com
Details Contact Person (Public Query)
Dr chetan Mehndiratta
Sr. Medical Advisor
sponsor representative
Ranbaxy Laboratories Ltd, Western Edge-I, Unit no. 201-204, 2nd
Floor, Western Express Highway, Borivali (E), Mumbai
Mumbai (Suburban)
MAHARASHTRA
400066
India
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9920590710

Chetan.Mehndiratta@ranbaxy.com
Source of Monetary or Material Support
201-204, 2nd Floor, Western Express

Primary Sponsor Details

Ranbaxy Laboratories Ltd
Western Edge-I, Unit no. 201-204, 2nd Floor, Western Express
Highway, Borivali (E), Mumbai- 400066
Pharmaceutical industry-Indian
Address
NIL

Name of Site Site Address Phone/Fax/Email

Advanced urology and 1, Ground floor, 9819486446

Lithotripsy clinic, Parwana Towers, Opp. drrajeshb@rediffmail.co
Axis Bank, Saibaba m
Nagar, Borivali(West),
Mumbai-400092
Mumbai (Suburban)
MAHARASHTRA

Patel Hospital Civil Lenes, 9815650541

Jalandhar(PB)-144001 swapansood@hotmail.c
Jalandhar om
PUNJAB

Ratkal Speciality No.6, 3rd Cross, I R 080-64520058

Hospital, Block, Rajajinagar, dr.csratkal@gmail.com
Banglore- 560010
Bangalore
KARNATAKA

RG Stone Urological AMRI Hospital, P4 & 5 9831296244

research institute CIT Scheme LXXII, dramitava@yahoo.com
Block A, Gariahat,
Kolkata- 700029
Kolkata
WEST BENGAL

urolap superspeciality 903, Montreal, 9869346201

clinic, Shastrinagar, drhemendrashah@yah
Lokhandwala, Andheri oo.co.in
(W)-400053
Mumbai (Suburban)
MAHARASHTRA

Approval Status Date of Approval Is Independent Ethics

Committee?
Approval Status Date of Approval Is Independent Ethics
Committee?
Approved 23/02/2014 No

Approved 23/02/2014 No

Date
No Date Specified

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Condition
Indian male patients with lower urinary tract
symptoms associated with benign prostatic
hyperplasia.

Name Details
Silodal (Silodosin 8mg) OD 12 weeks
nil nil
Inclusion Criteria
45.00 Year(s)
80.00 Year(s)
Male
1. Outpatients aged 45 or over<br/> 2. Patients with a total I-PSS
score of 13 or higher<br/> 3. Patients with a prostate volume
measured by transabdominal ultrasonography or TRUS of ? 20
ml.<br/> 4. Patients with a maximum urinary flow rate (Qmax) of
4-15ml/sec (with voided urine volume ?125 ml).<br/>

Exclusion Criteria
 1. Patients with a residual urinary volume of ?250ml
2. Patients with a history of prostatectomy
3. Patients with PSA level > 4.0ng/mL
4. Patients with a history of intrapelvic radiation therapy
5. Patients with prostate cancer or suspected prostate cancer
6. Patients with complications considered likely to affect urinary
passing such as neurogenic bladder, bladder calculus and active
urinary tract infection.
7. Patients conducting self-catheterization
8. Patients with renal impairment
9. Patients with hepatic impairment.
10. Patients with history of severe arrhythmia, cardiac failure, cardiac
infarction, unstable angina, cerebral infarction within 6 months
11. Patients with a history of an allergy to ?-blockers
12. Patients with orthostatic hypotension at around screening visit
13. Patients with an experience of other investigational product
treatments within 4 weeks form screening visit.
14. Patients who have taken unstable doses of antidepressants
within the 3 months or who are expected to take unstable doses
during the study
15. Patients who have taken alpha blockers within the 2 weeks from
the start of the therapy
16. Patients who have taken unstable doses of 5?-reductase
inhibitors within the 3 months from the start of the therapy or who are
expected to take unstable doses during the study.
17. Patients who have a history or evidence of a medical condition
that would expose them to an undue risk of a significant adverse
event or interfere with the assessments of safety or efficacy during
the course of the trial, including but not limited to hepatic, renal,
respiratory, cardiovascular, endocrine, immune, neurological,
psychiatric, or hematological disease as determined by the clinical
judgment of the investigator.
18. Any contra-indication to silodosin as mentioned in the prescribing
information.

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Outcome Timepoints
ymptoms as assessed by over 12 weeks (at 3 days, 1 week, 4 weeks, and
al Prostate Symptom 12 weeks)
 Outcome Timepoints
w rate measured by change 2 hours, 4 weeks, and 12 weeks

ng and storage symptoms 3 days, 1 week, 4 weeks and 12 weeks.

n IPSS voiding and

n QOL due to urinary 3 days, 1 week, 4 weeks and 12 weeks.

aluate the percentage of treatment responders 4 weeks, and 12 weeks

in IPSS score from baseline

aluate the percentage of treatment responders 4 weeks, and 12 weeks

ment in Qmax from baseline of

tolerability by all visits over the 12 weeks

ence and severity of adverse

Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials

Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials

and examination of the patients

d based on the inclusion and
nt’ will be obtained from these
e study. Patients will be
cts of the treatment as per the

Commercially available Silodal would be prescribed at the discretion of the

investigator and will not be provided by the investigator to the patients. The
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prescribed dose of 8 mg

day 3 and
to rule out
 page 5 / 5

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rial Registered Retrospectively

ects of darifenacin and trospium on eye, the

sed frequency of urination, urgency, nocturia

side effects of darifenacin and trospium in

Identifier
NIL
Details of Principal Investigator
Dr Manjunatha R
PG cum Tutor, Department of Pharmacology, KIMS, Bangalore
Kempegowda Institute of Medical Sciences, Bangalore.
Department of Pharmacology, Kempegowda Institute of Medical
Sciences, Banashankari 2nd stage, Bangalore. Bangalore
KARNATAKA 560070 India
Bangalore
KARNATAKA
560070
India

8951155519

manjunatha5ramaiah@gmail.com
Details Contact Person (Scientific Query)
Dr H P Pundarikaksha
Professor and Head
Kempegowda Institute of Medical Sciences, Bangalore.
Department of Pharmacology, Kempegowda Institute of Medical
Sciences, Banashankari 2nd stage, Bangalore. Bangalore
KARNATAKA 560070 India
Bangalore
KARNATAKA
560070
India

9880052054
 drpundarikahp@gmail.com
Details Contact Person (Public Query)
Dr Manjunatha R
PG cum Tutor, Department of Pharmacology, KIMS, Bangalore
Kempegowda Institute of Medical Sciences, Bangalore.
Department of Pharmacology, Kempegowda Institute of Medical
Sciences, Banashankari 2nd stage, Bangalore. Bangalore
KARNATAKA 560070 India

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KARNATAKA
560070
India
8951155519

manjunatha5ramaiah@gmail.com
Source of Monetary or Material Support

Primary Sponsor Details

Dr Manjunatha R self
Department of Pharmacology, Kempegowda Institute of Medical
Sciences, Banashankari 2nd stage, Bangalore. Bangalore
KARNATAKA 560070 India
Other [self]
Address
NIL

Name of Site Site Address Phone/Fax/Email

Department of Urology, Department of Urology, 8951155519
KIMSH & RC Department of surgical manjunatha5ramaiah@
superspecialities, 1st gmail.com
floor, B block,
Kempegowda Institute
of Medical Sciences
Hospital and Research
Centre, V V Puram,
Bangalore 560004
Bangalore
KARNATAKA

Approval Status Date of Approval Is Independent Ethics

Committee?
Approved 07/11/2013 No
Date
No Date Specified
Condition
patients with frequency, urgency, nocturia with or
without urgency urinary incontinence with normal
and stable general condition

Name Details
Darifenacin 7.5mg Tab Darifenacin 7.5mg, once
daily at night for 14 days
Trospium 60mg Tab Trospium 60mg, once daily,
one hour before meals with full
glass of water either in the
morning or at the night based
on patients problems and
preference for 14 days

Inclusion Criteria
18.00 Year(s)

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80.00 Year(s)
Both
 •Male and female patients aged >18 and <80 years <br/> •Patients
with a baseline score for urinary urgency of ?2 points, day time
frequency >1 point and a total OABSS of ?3 points, with or without
urgency urinary incontinence (UUI) episodes <br/> •Symptoms of
OAB for at least 4 weeks <br/> •Patients with stable doses of alpha
blockers or 5-alpha-reductase inhibitors for patients with benign
prostatic hyperplasia were permitted with the limitation that a specific
drug was used without a change in dosage and administration and
was not replaced with another drug during the study period
(observation and treatment phase).<br/>

Exclusion Criteria
•Serious heart disease,
•Untreated angle-closure glaucoma,
•Myasthenia gravis,
•Gastric outlet and intestinal obstruction, paralytic ileus, gastric and
intestinal atony or risk of urinary or gastric retention.
•Residual urine volume ?100 mL (determined by abdominal
sonography)
•Strong possibility of prostate and bladder cancer
•Acute active urinary tract infection
•Women of childbearing age were required not to be pregnant or
nursing, and to be using acceptable methods of contraception.
•Concomitant treatments known to affect urinary bladder function
like anticholinergics, antispasmodics,
serotonin-noradrenaline-reuptake-inhibitors, TCA, first generation
antihistaminics, cholinergic agonists, cholinesterase inhibitors (e.g.
bethanecol, donepezil and rivastigmine), potent inhibitors of
cytochrome CYP3A4 (e.g. ketoconazole, itraconazole, ritonavir,
nelfinavir, clarithromycin and nefazadone), potent P-glycoprotein
inhibitors (e.g. cyclosporine and verapamil), aluminum antacids,
antiparkinson and antipsychotic drugs, Calcium channel blockers,
opioids, muscle relaxants, angiotensin-converting enzyme inhibitors,
anticoagulants.
•Patients on digoxin or metformin
•Severe hepatic or renal dysfunction
•Participation in a clinical trial within 30 days before study entry.
•History of alcohol or drug abuse
•Currently suffering from serious disease or malignancy
•Significant psychiatric problems
•Dry eyes, ocular surface disorders, glaucoma, or issues that could
affect visual acuity or accommodation (such as cataract, macular
degeneration, or history of ocular surgery)

Outcome Timepoints
baseline (day 0) and end of study (day 14)

Outcome Timepoints
 baseline (day 0) and end of study (day 14)

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ble only for Completed/Terminated trials

ble only for Completed/Terminated trials

with similar efficacy which is not inferior to

e treatment of OAB.
reatment were dry mouth (reported by 20.1%
e of dry eye is reported to be 1.5% and 2.1%
oduct information. The P-glycoprotein (P-gp)
t its penetration into brain and ocular tissue

nd which is non?selective for muscarinic

t crosses the blood–brain barrier to a limited
effects. However, there are no molecular
r barrier which also is equipped with the p-gp
um 20mg is 1.2% in its product information

darifenacin and trospium chloride

unique properties. Hence, the
he same
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:- Sun, 08 Jan 2023 05:04:44 GMT)

CTRI/2014/08/004811 [Registered on: 04/08/2014] - Trial Registered Retrospectively

allel Group, Placebo Controlled Trial

‘Tamsulosin and darifenacin’ versus ‘tamsulosin’ for ‘benign prostate hypertrophy with
dder’
Efficacy and safety of ‘tamsulosin and darifenacin’ versus ‘tamsulosin monotherapy’ for ‘BPH
companying overactive bladder’- a randomized clinical study.
Identifier
NIL
Details of Principal Investigator
Dr Iqbal Singh
Professor
University College of Medical Sciences University of Delhi GTBH
 Department of Surgery University College of Medical Sciences
University of Delhi GTBH Shahadara Delhi 95
East
DELHI
110095
India

iqbalsinghp@yahoo.co.uk
Details Contact Person (Scientific Query)
Dr Gaurav Garg
Post Graduate Junior Resident
University College of Medical Sciences University of Delhi GTBH
Department of Surgery University College of Medical Sciences
University of Delhi GTBH Shahadara Delhi 95
East
DELHI
110095
India

gougarg@gmail.com
Details Contact Person (Public Query)
Dr Gaurav Garg
Post Graduate Junior Resident
University College of Medical Sciences University of Delhi GTBH
Department of Surgery University College of Medical Sciences
University of Delhi GTBH Shahadara Delhi 95
East
DELHI
110095
India

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gougarg@gmail.com
Source of Monetary or Material Support
of Delhi Delhi110095
Primary Sponsor Details
 University College of Medical Sciences
University College of Medical Sciences University of Delhi
Delhi110095
Government medical college
Address
NIL

Name of Site Site Address Phone/Fax/Email

UCMS GTBH Dept of 22586262

Surgery(Urology Div) iqbalsinghp@yahoo.co.
University College of uk
Medical Sciences
University of Delhi and
GTB Hospital
Shahadara Delhi 95
East
DELHI

Approval Status Date of Approval Is Independent Ethics

Committee?
Approved 26/10/2012 No

Date
No Date Specified
Condition
Benign prostate hypertrophy (BPH) with
accompanying overactive bladder (OAB).
Benign prostatic hyperplasia withlower urinary
tract symptoms

Name Details
Tab Tamsulosin Hydrochloride Tab Tamsulosin Hydrochloride
Cap Darifenacin Hydrobromide 0.4mg given orally once a day at
bed time after meals with sips of
water for period of eight weeks.
Darifenacin Hydrobromide
7.5mg given as capsule once a
day at bed time with sips of
water for eight weeks.

Cap Lactobacillus Cap Cap Lactobacillus containing

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Tamsulosin 400 million lactobacillus

Acidophillus per capsule given
in dose of one capsule orally
once daily at bed time after
meals with sips of water for
eight weeks. Cap Tamsulosin
Hydrochloride 0.4mg given
orally once a day at bed time
after meals with sips of water for
period of eight weeks.

Inclusion Criteria
40.00 Year(s)
80.00 Year(s)
Male
1. Male patients aged 40-80 years diagnosed as symptomatic BPH
with accompanying OAB with an IPSS >8 and not desiring
surgery.<br/> 2. Symptomatic patients of BPH (determined by LUTS
and supplemented by IPSS/focused urological exam/Investigations)
associated with any one or more of the following overactive bladder
symptoms like; micturition frequency of >8 per 24 hrs, nocturia
episodes of > 2 per 24 hrs, urgency episodes of > 1 per 24 hrs with
or without urge incontinence.<br/> 3. Patients willing and able to
complete a 3 day voiding diary and questionnaires.<br/>

Exclusion Criteria
zation

Outcome Timepoints
Mean change from baseline to week 8 in number
of urinary frequencies in 24 hours and mean
change in number of incontinence episodes per
day that resulted in change in clothing.

Outcome Timepoints
8 weeks

mbers achieved (Total)=

mbers achieved (India)=
 Rationale: BPH is a widely prevalent voiding disorder in the ageing population and there is scarcity
of global literature comparing the efficacy and safety of darifenacin in combination with tamsulosin
sulosin monotherapy in patients of BPH with OAB.

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‘tamsulosin and darifenacin’ therapy versus

with accompanying OAB. To compare the
ifenacin’ therapy versus ‘tamsulosin monotherapy’ for

tic patients of BPH with any one or more of the following

nocturia > 2 , urgency > 1 per 24 hours between
proval by local ethics committee and obtaining informed
d to receive either tamsulosin 0.4mg plus placebo (T+P)
in 7.5 mg (T+D) (n=30) for 8 weeks. The mean change in
sodes/24 hours (primary end points), and nocturnal
IPSS (secondary end points) were compared

incontinence and nocturnal frequency / 24 hours

(-1.50 vs.-1.08, p=0.001), (-2.20 vs. -1.87, p=0.000) and
group respectively (significant). Apart from some minor
peared to be safe and well tolerated in both groups. The
10.84ml and -16.93) in the T+D/T+P groups respectively,
was 13% and 3% in the T+D/T+P group respectively(p=0.35).

darifenacin for 8 weeks is an effective and safe

nying OAB symptoms.
 page 4 / 4

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:- Sun, 08 Jan 2023 05:04:50 GMT)

rial Registered Retrospectively

f Pelvic plexus block in pain reduction during

f Pelvic plexus block in pain reduction during

ng transrectal ultrasound guided biopsy of the

Identifier
NIL
Details of Principal Investigator
Tarun Jindal
Senior Resident
Calcutta National Medical College
Department of Urology, Calcutta National Medical College,
Gorachand Road, Kolkata
Kolkata
WEST BENGAL
700014
India

drtarunjindal@gmail.com
Details Contact Person (Scientific Query)
Tarun Jindal
Senior Resident
Calcutta National Medical College
Department of Urology, Calcutta National Medical College,
Gorachand Road, Kolkata
Kolkata
WEST BENGAL
700014
India

drtarunjindal@gmail.com
Details Contact Person (Public Query)
tarun jindal
Senior Resident
Calcutta National Medical College
Department of Urology, Calcutta National Medical College
Gorachand Road, Kolkata
Kolkata
WEST BENGAL
700014
India

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drtarunjindal@gmail.com
Source of Monetary or Material Support

Primary Sponsor Details

Tarun Jindal
Department of Urology, Calcutta National Medical College
Gorachand Road, Kolkata
Other [Investigator]
Address
NIL

Name of Site Site Address Phone/Fax/Email

department of Urology, 32, Gorachand Road 9674444929

Calcutta National Kolkata drtarunjindal@gmail.co
medical College WEST BENGAL m

Approval Status Date of Approval Is Independent Ethics

Committee?
Approved 21/12/2011 Yes

Date
No Date Specified
Condition
Patients with an abnormal prostate on a digital
rectal examination and/or serum prostate
specific antigen more than 4 ng/ml were included
in the study.

Name Details
Placebo group TRUS probe was inserted but
no block was given
Pelvic plexus block 5 ml of 25 lignocaine injection
was given on each side into the
pelvic neurovascular plexus,
situated lateral to the tip of the
seminal vesicles under colour
Doppler guidance
 Peri prostatic block 5ml of 2% lignocaine injection
was given on each side into the
neurovascular bundles at the
prostate-bladder-seminal
vesicle junction

Inclusion Criteria
40.00 Year(s)
80.00 Year(s)
Male

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Patients with an abnormal prostate on a digital rectal examination

and/or serum prostate specific antigen (PSA) of > 4 ng/ml were
included in the study.

Exclusion Criteria
Those who have had a previous transrectal prostate biopsy, chronic
prostatitis/pelvic pain, neurological conditions, bleeding diathesis,
anticoagulation/antiplatelet therapy, active UTI, haemorrhoids/ anal
fissure/ anal fistula, known allergy to lignocaine were excluded from
the study.

d
Outcome Timepoints
The evaluation of pain using the visual analogue
scale will be made at two pints:
1) During the biopsy
2) 30 minutes following the biopsy

Outcome Timepoints
The patients were observed for 2 hours after the
procedure.The patients were reviewed again at
the end of two weeks to assess the late
complication rate.
still controversial. We evaluate the effect of
and compare it with the conventional
study to assess the overall benefit of both the

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:- Sun, 08 Jan 2023 05:05:00 GMT)

rial Registered Prospectively

nt Effects of Dabigatran (Pradaxa)

study of the reversal of the anticoagulant
5.0g idarucizumab (BI 655075) in patients
d bleeding or require emergency surgery or

Identifier
Protocol Number
Details of Principal Investigator
 Details of Principal Investigator

Details Contact Person (Scientific Query)

Ravi Gaware
Clinical Research Manager
Boehringer Ingelheim India Pvt. Ltd.
1102, Hallmark Business Plaza Gurunanak Hospital Road, Bandra
East Mumbai
Mumbai
MAHARASHTRA
400051
India

26456477
26456163
ravi.gaware@boehringer-ingelheim.com
Details Contact Person (Public Query)
Partha Gokhale
Head - Clinical Operations
Boehringer Ingelheim India Pvt. Ltd.
1102, Hallmark Business Plaza Gurunanak Hospital Road, Bandra
East Mumbai
Mumbai
MAHARASHTRA
400051
India

26456477

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26456163
partha.gokhale@boehringer-ingelheim.com
Source of Monetary or Material Support
 Source of Monetary or Material Support

Primary Sponsor Details

Boehringer Ingelheim
1102, Hallmark Business Plaza Gurunanak Hospital Road, Bandra
East Mumbai 400051
Pharmaceutical industry-Global
Address
NIL

Name of Site Site Address Phone/Fax/Email

All India Institute of Department of 91-9810819167

Medical Sciences Neurology, Ansari 91-11-26588022
(AIIMS) Nagar, New Delhi - vasanthapadma123@g
110029 mail.com
North
DELHI

Asian Heart Institute Department of 91-22-66896666

Cardiology, G/N Block, 91-22-66896506
Bandra Kurla Complex, santosh.dora@ahirc.co
Bandra East, Mumbai - m
400051
Mumbai
MAHARASHTRA

B.M. Birla Heart Department of 91-9830048563

research Centre Cardiology, 1/1 National dhiman.kahali@gmail.c
Library Avenue, om
Kolkatta - 700027
Kolkata
WEST BENGAL
Care Hospitals Department of 91-712-3982222
Cardiology, 3, 91-712-2440803
Farmland, Panchasheel drvarun2007@rediffmail
Square, Nagpur - .com

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440010
Nagpur
MAHARASHTRA
Department of 91-9811150518
Cardiology, Room 23, 91-11-47135138
Residential Tower; RC upendra.kaul@fortishea
Block, Okhla Road, lthcare.com
New Delhi - 110025
North
DELHI

Department of 91-80-41994444
Cardiology, No.14, 91-80-22281149
Cunningham Road, rkeshava@hotmail.com
Sheriffis Chamber,
Bangalore - 560052
Bangalore
KARNATAKA

Department of 91-9616279212
Cardiology, Lucknow - sharadchandra_2612@
226003 yahoo.co.in
Lucknow
UTTAR PRADESH

Department of 91-80-23376977
Cardiology, Clinical 91-80-23601983
Research Center, 1st anupamadnb@rediffmai
floor, New Bel Road, l.com
Bangalore - 560054
Bangalore
KARNATAKA

Department of 91-9810331109
Cardiology, FC 50, 91-11-49782233
CAD block, Shallmar drnaresh.goyal@maxhe
Bagh, New Delhi - althcare.com
110088
North
DELHI
Department of 91-9871001190
Cardiology, Saket, New 91-11-26565050
Delhi - 110017 viveka.kumar@maxheal
North thcare.com
DELHI

Department of 91-9810442884
Cardiology, Sector 38, 91-124-4834111
Gurgaon - 122001 arun.garg@medanta.or
North g
DELHI

Department of 91-80-71222222
Cardiology, 258/A 91-80-27835208
Bommasandra drggshetty@gmail.com
Industrial Area, Anekal
Taluka, Bangalore -
560099
Bangalore
KARNATAKA

Department of 91-9822034710
Cardiology, Sasoon 91-20-26162277
Road, Pune - 411001 ravibgulati@gmail.com
Pune
MAHARASHTRA

page 3 / 7

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Sahara India Medical Department of 91-9721180999

Institute Cardiology, Viraj 91-522-6782110
Khand, Gomti Nagar, sinha.nakul@gmail.
Lucknow - 226010
Lucknow
UTTAR PRADESH

Sir Ganga Ram Department of 91-11-43594466

Hospital Cardiology, Marg, 91-11-42437230
Rajinder Nagar, new bhuwaneshk@yahoo.co
Delhi - 110060 .in
North
DELHI

Approval Status Date of Approval Is Independent Ethics

Committee?
Not Applicable No Date Specified No

Approved 09/08/2014 No
Not Applicable No Date Specified No

Approved 20/01/2015 No

Approved 13/02/2015 No

Approved 19/09/2014 No

Approved 05/11/2014 No

Approved 25/09/2014 No

Approved 01/09/2014 No

Approved 04/04/2015 No

Not Applicable No Date Specified No

Not Applicable No Date Specified No

Approved 09/12/2014 No

Not Applicable No Date Specified No

Date
27/08/2014

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Condition
In patients treated with dabigatran etexilate
(Pradaxa) who have uncontrolled bleeding or
require emergency surgery or procedures.

Name Details
 Name Details
Idarucizumab (BI 655075) Idarucizumab is a humanized
monoclonal antibody fragment
(Fab), administered as an
intravenous infusion. The drug
product (50mg/ml) is formulated
as a buffered, isotonic,
preservative-free solution of
idarucizumab. The total dose
administered is 5 g. The
patients will receive 5 g of study
drug, administered as two
separate infusions of 2.5g, no
more that 15 minutes apart .

There is no Comparator agent Not Applicable

or drug used in this trial

Inclusion Criteria
18.00 Year(s)
99.00 Year(s)
Both
Patients taking dabigatran are eligible for this study if they meet the
following criteria:<br/> <br/> Group A:<br/> 1. Overt bleeding judged
by the physician to require a reversal agent.<br/> 2. Currently taking
dabigatran etexilate.<br/> 3. Age ? 18 years at entry.<br/> 4. Written
Informed consent.<br/> <br/> Group B:<br/> 1. A condition requiring
emergency surgery or procedure where adequate hemostasis
is<br/> required. Emergency is defined as within the next 4
hours.<br/> 2. Currently taking dabigatran etexilate.<br/> 3. Age ? 18
years at entry.<br/> 4. Written Informed consent.

Exclusion Criteria
Group A:
1. Patients with minor bleeding (e.g. epistaxis, hematuria) who can
be managed with
standard supportive care.
2. Patients with no clinical signs of bleeding.
3. Contraindications to study medication including known
hypersensitivity to the drug or
its excipients.
Group B:
1. A surgery or procedure which is elective or where the risk of
uncontrolled or
unmanageable bleeding is low.
2. Contraindications to study medication including known
hypersensitivity to the drug or
its excipients.

Outcome Timepoints
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An interim analysis is planned after recruitment

of 10-25 patients (globally) to demonstrate
reversibility of anticoagulant effect of Dabigatran.
We anticipate approximately 3 years will be
required to recruit target number of 250-300
patients. The final analysis will be planned after
recruitment of target number of patients.

Outcome Timepoints
These analyses of the secondary outcome will
be available during Interim analysis (planned
after recruitment of 10-25 patients) and after final
data base lock.

ble only for Completed/Terminated trials

ble only for Completed/Terminated trials

ted for regulatory approval, these data may

on dabigatran, including life-threatening or

ion of blood or blood products and the
ere has been no treatment that directly
h an antidote has the potential to improve the
eeding. Bleeding may be reduced or

atran and who have co-morbidities may need

morbidities, e.g. cardiac catheterization for a
tient with acute appendicitis or major trauma
iate reversal of the anticoagulant effect of
on dabigatran, including life-threatening or
ion of blood or blood products and the
ere has been no treatment that directly
h an antidote has the potential to improve the
eeding. Bleeding may be reduced or

atran and who have co-morbidities may need

morbidities, e.g. cardiac catheterization for a
tient with acute appendicitis or major trauma
iate reversal of the anticoagulant effect of
e bleeding associated with the surgery or

by idarucizumab, has been demonstrated in

tients or those requiring emergency
is designed to demonstrate the reversibility of
nd to support the approval of a License

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 page 7 / 7

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rial Registered Retrospectively

orrectly ?
cted on basis of patients weight provide an

Identifier
NIL
Details of Principal Investigator
Dr Aparna Chatterjee
Professor
Tata Memorial Hospital
Dept of Anesthesia Critical Care & Pain 2 nd floor Main Building Tata
Memorial Hospital Parel Mumbai
Mumbai
MAHARASHTRA
400012
India

24177051

aparnasanjay@hotmail.com
Details Contact Person (Scientific Query)
Dr Anamika Yadav
Post graduate student
Tata Memorial Hospital
Dept of Anesthesia Critical Care & Pain 2 nd floor Main Building Tata
Memorial Hospital Parel Mumbai
Mumbai
MAHARASHTRA
400012
India

09766919294

ana_yadav11@yahoo.co.in
Details Contact Person (Public Query)
Dr Aparna Chatterjee
 Dr Aparna Chatterjee
Professor
Tata Memorial Hospital
Dept of Anesthesia Critical Care & Pain 2 nd floor Main Building Tata
Memorial Hospital Parel Mumbai
Mumbai
MAHARASHTRA
400012
India

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aparnasanjay@hotmail.com
Source of Monetary or Material Support
ai 400012
Primary Sponsor Details
Tata Memorial Hospital
Dr E Borges Marg Parel Mumbai 400012
Research institution and hospital
Address
NIL

Name of Site Site Address Phone/Fax/Email

Tata Memorial Centre Department of 02224177051

Anesthesia Critical aparnasanjay@hotmail.
Care & Pain Room No com
94 2nd floor Main
Building Tata Memorial
Hospital Dr E Borges
Marg Parel Mumbai
400012
Mumbai
MAHARASHTRA

Approval Status Date of Approval Is Independent Ethics

Committee?
Approved 05/06/2014 No

Date
 Date
No Date Specified
Condition
Adult patients undergoing surgeries under
general anaesthesia with a SLMA to provide the
airway and eligible as per inclusion criteria
Neoplasms
Name Details

Inclusion Criteria
18.00 Year(s)
99.00 Year(s)
Both
1.Adult patients (>18 years) <br/> 2.Surgeries such as implant
placement for radiotherapy, breast surgeries ,bone or soft tissue
surgery ,urology surgeries like penectomy, TURBT, orchidectomy
,other surface surgeries of < 3 hours duration.<br/> 3.An LMA
supreme used for providing General Anesthesia<br/>

Exclusion Criteria
1. Pediatric patients
2.ASA Grades 3 and below
3.Emergency surgery

PDF of Trial
CTRI Website URL - http://ctri.nic.in

Outcome Timepoints
At insertion of SLMA after induction of
Anesthesia

Outcome Timepoints
24 hours after surgery
sk airway (SLMA) selected on the basis of a
ion? J Anesth Crit Care Open Access.
0396
replaced the endotracheal tube as the
upreme laryngeal mask (SLMA) a
e recent developments of the
of the most advanced laryngeal
atex free device with an anatomic
t-in bite block and a fixation tab to
n is oval which improves the
mizing dislodgements.The SLMA
n and a high volume –low
eal pressure both aiming to
of gastric contents.Tests
ng, i.e separation of the

th lubricant (lignocaine gel). With

be no bubbles appearing at the
cate an incomplete separation of
isk of gastric inflation. With the tip

PDF of Trial
CTRI Website URL - http://ctri.nic.in

r esophagus, an unobstructed gastric

ressing on the sternal notch over the
and produce bubbles at the
erted through the gastric tube of the
problems and the stomach should be
 page 4 / 6

PDF of Trial
CTRI Website URL - http://ctri.nic.in
 page 5 / 6

PDF of Trial
CTRI Website URL - http://ctri.nic.in
page 6 / 6
URL - http://ctri.nic.in
 page 1 / 12

URL - http://ctri.nic.in
hone/Fax/Email

936507362
522-4101017
deepakdewan@rediff
ail.com

9899390027
emnathdogra@gmail.
m

814034185
mammen@gmail.com

1-9823266762
hadke.pratibha@gmail
om

810005182
soodr@gmail.com

page 2 / 12
 URL - http://ctri.nic.in

1512202131
rpagrawal@yahoo.co

824047750
janakddesai@gmail.c
m

986143260
anju2586_suri@rediff
ail.com

9419004822
arvaizk@gmail.com

810233670
sudhirchadha@gmail.
m
829017619
nkhippal@rediffmail.c
m

839056553
akumar221@gmail.co

415221720
murticrvns@gmail.co

Independent Ethics
ommittee?
o

page 5 / 12
URL - http://ctri.nic.in
o

o
o

is 23 to 32
d+ TOC +
pon
r each
nistration:

is 23 to 32
d+ TOC +
pon
r each
nistration:
d
y
e
ther
or
RTI
nd/or
and
nd
P
sults

page 7 / 12

URL - http://ctri.nic.in
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URL - http://ctri.nic.in
page 9 / 12
URL - http://ctri.nic.in
 page 1 / 8

URL - http://ctri.nic.in

hone/Fax/Email
9881256992
searchamai@gmail.c
m

09830339217
vmahendra@gmail.com

322589110
pratit@gmail.com

433254601
hiri.arpi@gmail.com

9415028046
ahwakgmu@yahoo.co

9892706382
sharadprasad@gmail.
m

8326711541
omgoa@gmail.com

page 2 / 8

URL - http://ctri.nic.in
9829696995
jainalok@gmail.com

7926760646
edilinkresearchcentre
yahoo.com

426422002
2682520248
sabnis@gmail.com

336077839
ndeepkumar.gupta@
diffmail.com

9766321910
sandeepsd@gmail.co

415410130
apoor@sgpgi.ac.in

9828015854
riyadarshi64@gmail.c
m

1416450553
mohan2001@yahoo.
.uk

Independent Ethics
ommittee?
o
o

page 3 / 8

URL - http://ctri.nic.in

o
o

at least
opran 1

page 4 / 8

URL - http://ctri.nic.in

switched
ment with
ubjects
tic therapy
ofloxacin
complete
the 10
The total
therapy
r i.v. study

0 days.
upon the
e subject,
ent can be
at the
on.
 at least
ome,
hed to
nt with
ubjects
tic therapy
ofloxacin
complete
the 10
The total
therapy
r i.v. study

0 days.
upon the
e subject,
ent can be
at the
on.

page 5 / 8

URL - http://ctri.nic.in
 page 6 / 8

URL - http://ctri.nic.in
 page 7 / 8

URL - http://ctri.nic.in
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URL - http://ctri.nic.in
 page 1 / 4

URL - http://ctri.nic.in

hone/Fax/Email

8004019936
.rajeevkumar2@gmail
om

Independent Ethics
ommittee?
o

0mg
eceive
y after
eritoneum
of kidney
 0mg
eceive
y after
eritoneum
of kidney

mg
l receive
ation of
before the
n and
rgery just

page 2 / 4

URL - http://ctri.nic.in
 page 3 / 4

URL - http://ctri.nic.in
page 4 / 4
URL - http://ctri.nic.in
 page 1 / 6

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hone/Fax/Email

9438554039
sarat2010@rediffmail.
m
840078979
sdoc@gmail.com

810113414
ssarora@gmail.com

876080057
mitbery@yahoo.co.in

176007063
dm58@gmail.com

page 2 / 6
URL - http://ctri.nic.in
417532955
vismi2003@yahoo.co

960686867
achee.sathe@gmail.c
m

419004822
arvaizk@gmail.com

Independent Ethics
ommittee?
o

o
o

page 4 / 6

URL - http://ctri.nic.in

o
o

days
 page 5 / 6

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 page 6 / 6

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page 1 / 12
 URL - http://ctri.nic.in

hone/Fax/Email

822059799
shamsi@hotmail.com
4023431725
udhvi.s@aherf-smo.o

823949126
kpjadhav@hotmail.co

page 2 / 12
 URL - http://ctri.nic.in

810195227
1957@gmail.com

414515858
yadavsms@gmail.co

1-80-40416789
raghunathsk@yahoo.
m

8026614062
ohan.urology@gmail.
m
892706382
sharadprasad@gmail.
m

Independent Ethics
ommittee?
o

page 5 / 12
URL - http://ctri.nic.in

of Watson
a. 176
l receive
h patients
capsule
s daily for
of Watson
a. 176
l receive
h patients
capsule
s daily for

of
n
176
l receive
drug.
ill receive
ly three
s.

on Pharma
atients out
mparator
patients
capsule
s daily for

page 8 / 12

URL - http://ctri.nic.in
 page 9 / 12

URL - http://ctri.nic.in

91 days (90 days

eatment).
performed at:
(Day-3)
tion Visit (Day 1)
y 15 ± 4 Days)
Day 30 ± 4 Days)
ay 60 ± 4 Days)
Day 90 ± 4 Days)

91 days (90 days

eatment).
performed at:
(Day-3)
tion Visit (Day 1)
y 15 ± 4 Days)
Day 30 ± 4 Days)
ay 60 ± 4 Days)
Day 90 ± 4 Days)
page 10 / 12
URL - http://ctri.nic.in
 page 1 / 4

URL - http://ctri.nic.in

hone/Fax/Email

951155519
anjunatha5ramaiah@
mail.com

Independent Ethics
ommittee?
o
, oral

s, oral

hs, oral

page 2 / 4

URL - http://ctri.nic.in
page 3 / 4
URL - http://ctri.nic.in
 page 1 / 5

URL - http://ctri.nic.in

hone/Fax/Email

18879614446
sivaprasad@yahoo.c
m
12266660000
12266660566
pratit@gmail.com

12266487570
12226114500
neil4ever@yahoo.co

206137494
2026055094
jendrakshimpi@gmail
om

page 2 / 5

URL - http://ctri.nic.in

19426422002
sabnis@gmail.com
19824086834
shreniks@gmail.com

Independent Ethics
ommittee?
o

one
lly) for 12

page 3 / 5

URL - http://ctri.nic.in
mg, one
lly) for 12
 page 4 / 5

URL - http://ctri.nic.in
 page 5 / 5

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 page 1 / 4

URL - http://ctri.nic.in
hone/Fax/Email

413-2297335
orairajan_ln@hotmail.
m

Independent Ethics
ommittee?
o

ml of 1%
s penis in
volume of
tilled
d

sing
%
d
d

sing
%
d
gnostic
ble
 page 2 / 4

URL - http://ctri.nic.in
page 3 / 4
URL - http://ctri.nic.in
 page 1 / 3

URL - http://ctri.nic.in

hone/Fax/Email

951155519
anjunatha5ramaiah@
mail.com

Independent Ethics
ommittee?
 Independent Ethics
ommittee?
o

digit ratios
nteers will
parator
ond to
s of BPH

page 2 / 3

URL - http://ctri.nic.in
 page 3 / 3

URL - http://ctri.nic.in
 page 1 / 4

URL - http://ctri.nic.in

hone/Fax/Email

951155519
anjunatha5ramaiah@
mail.com

Independent Ethics
ommittee?
o
months
months.
onths.

page 2 / 4

URL - http://ctri.nic.in
page 3 / 4
URL - http://ctri.nic.in
 page 1 / 5

URL - http://ctri.nic.in
hone/Fax/Email

0161-5026999
0161-2228780
drjchhatwal@gmail.com

11-23361228
1-11-23360067

page 2 / 5

URL - http://ctri.nic.in

soodr@yahoo.com

0919822059799
0912026055094
jendrakshimpi@gmail
om

00919839181465
00915222256543
drapul.goel@gmail.com

Independent Ethics
ommittee?
 Independent Ethics
ommittee?
o

page 3 / 5

URL - http://ctri.nic.in

C
nce daily
C
nce daily
first week

nce daily
 page 4 / 5

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 page 5 / 5

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 page 1 / 6

URL - http://ctri.nic.in

hone/Fax/Email

004904439
.divshri@gmail.com

Independent Ethics
ommittee?
o
 allograft
ml/kg/hr,
n

transplant
eved high

5ml/kg/hr,
n 12-15

page 2 / 6

URL - http://ctri.nic.in
page 3 / 6
URL - http://ctri.nic.in
 page 1 / 5

URL - http://ctri.nic.in

hone/Fax/Email

004904439
.divshri@gmail.com

Independent Ethics
ommittee?
o

over 15
r,
 over 10

ously
period.

page 2 / 5

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page 3 / 5
URL - http://ctri.nic.in
 page 1 / 4

URL - http://ctri.nic.in

hone/Fax/Email

488516897
eeraj_agrus@yahoo.c
m

Independent Ethics
ommittee?
o
ed using
pe under
r
2%
and
ing
d. After
will be
n on VAS

stent will be removed using

exible cystoscope under local
aesthesia after instillation of
10ml of 2% lignocaine jelly.
ime and operative difficulty
ring procedure will be noted.
er the procedure, patient will
e asked to score his pain on
VAS from 1 to 10. all the
rameters will be compared to
se of semirigid ureteroscope.

page 2 / 4

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page 3 / 4
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 page 1 / 3

URL - http://ctri.nic.in

hone/Fax/Email

500674381
d6121984@yahoo.co.

Independent Ethics
ommittee?
es
 e study
nd guided
stomy
t.
undergo
d after
stomy and
f the
assessed

page 2 / 3

URL - http://ctri.nic.in
 page 3 / 3

URL - http://ctri.nic.in
 page 1 / 6

URL - http://ctri.nic.in

hone/Fax/Email

14044505555
doddala@gmail.com

19824035673
7926641658
aileshshahuro@yaho
com
11612600685
mammen@gmail.com

12612236036
pilthakkar@gmail.co

19945813327
18023394781
uralis_14@yahoo.co

19829064940
1412293800

page 2 / 6

URL - http://ctri.nic.in

_raviagrawal@rediffm
.com
18028374115
yathish@hotmail.com

11147022027
_rawal@hotmail.com
15222494137
nilpall@yahoo.com

19448055949
8042099074
luck@gmail.com

Independent Ethics
ommittee?
o

es

page 3 / 6

URL - http://ctri.nic.in
h depot

h depot

h depot
 page 4 / 6

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 page 5 / 6

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 page 6 / 6

URL - http://ctri.nic.in
 page 1 / 11

URL - http://ctri.nic.in
hone/Fax/Email

848050717
doddala@gmail.com

885256059
gopichand@yahoo.co
448055949
luck@gmail.com

886873788
al_muk@hotmail.com

page 2 / 11
 URL - http://ctri.nic.in

823061929
raj@manavatacancer
ntre.com

20-25676861
rakeshn@gmail.com

20-41236660
tusharp@gmail.com

Independent Ethics
ommittee?
o

o
o

page 6 / 11
URL - http://ctri.nic.in
o

o
1 Ram
alley, NY

artis
n,
buted by:

page 8 / 11

URL - http://ctri.nic.in

cals
over, New
 page 9 / 11

URL - http://ctri.nic.in
page 10 / 11
URL - http://ctri.nic.in
 page 1 / 6

URL - http://ctri.nic.in

hone/Fax/Email

9894786992
arthonline1981@gmail
om

Independent Ethics
ommittee?
o
ue, is
the depth
o the
with
h. Thus,
urface is
f a narrow
e
ue (415
m) zone of
pectrum.
ngths are

ular
CIS)

page 2 / 6
URL - http://ctri.nic.in
 e of low
majority
develop
so of low
cers are
half of
vasive.
stage, the
bladder
thorough
atment
he
e and
od for
tumour is
of the
deep
me
uscle,
en
ic
roach
lete
s and
gnostic
grade and
the
widely
. One of
which
ong
ts is the
tire
which
o the
use a
in the
es from
mall pTa
ours.
adder
ght, only
ch are
hite light
behind
cosa with
) not
WL, or
e detected
se can
urrence in
ence, any
d or
n of these
foci of CIS
me.
 page 4 / 6

URL - http://ctri.nic.in
page 5 / 6
URL - http://ctri.nic.in
page 1 / 5
 URL - http://ctri.nic.in

hone/Fax/Email

819486446
rajeshb@rediffmail.co

815650541
wapansood@hotmail.c
m

80-64520058
.csratkal@gmail.com

831296244
amitava@yahoo.com

869346201
hemendrashah@yah
o.co.in

Independent Ethics
ommittee?
 Independent Ethics
ommittee?
o

page 2 / 5

URL - http://ctri.nic.in
 page 3 / 5

URL - http://ctri.nic.in

ek, 4 weeks, and

eks.

eks.
page 4 / 5
URL - http://ctri.nic.in
 page 1 / 1

URL - http://ctri.nic.in
 page 1 / 4

URL - http://ctri.nic.in

hone/Fax/Email
951155519
anjunatha5ramaiah@
mail.com

Independent Ethics
ommittee?
o

g, once
ays
once daily,
s with full
n the
t based
and
s

page 2 / 4

URL - http://ctri.nic.in
 page 3 / 4

URL - http://ctri.nic.in
 page 4 / 4

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 page 1 / 4

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Phone/Fax/Email

22586262
iqbalsinghp@yahoo.co.
uk

Is Independent Ethics
Committee?
No

drochloride
once a day at
s with sips of
eight weeks.
romide
sule once a
h sips of
ks.

ontaining
 page 2 / 4

te URL - http://ctri.nic.in

acillus
apsule given
psule orally
time after
water for
Tamsulosin
mg given
at bed time
ips of water for
eks.

ts

ts
page 3 / 4
URL - http://ctri.nic.in
page 1 / 3
 URL - http://ctri.nic.in

hone/Fax/Email

674444929
tarunjindal@gmail.co

Independent Ethics
ommittee?
es

rted but

njection
de into the
plexus,
tip of the
r colour
 njection
de into the
s at the
nal

page 2 / 3

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 page 3 / 3

URL - http://ctri.nic.in
 page 1 / 7

URL - http://ctri.nic.in
hone/Fax/Email

1-9810819167
1-11-26588022
santhapadma123@g
ail.com

1-22-66896666
1-22-66896506
ntosh.dora@ahirc.co

1-9830048563
himan.kahali@gmail.c
m
1-712-3982222
1-712-2440803
varun2007@rediffmail
om

page 2 / 7
 URL - http://ctri.nic.in

91-9721180999
91-522-6782110
sinha.nakul@gmail.com

1-11-43594466
1-11-42437230
huwaneshk@yahoo.co

Independent Ethics
ommittee?
o

o
o

page 4 / 7

URL - http://ctri.nic.in
manized
ragment
s an
The drug
ormulated
,
tion of
al dose
he
g of study
two
2.5g, no
apart .
 page 5 / 7

URL - http://ctri.nic.in
page 6 / 7
URL - http://ctri.nic.in
 page 1 / 6

URL - http://ctri.nic.in

hone/Fax/Email

2224177051
parnasanjay@hotmail.
m

Independent Ethics
ommittee?
o
 page 2 / 6

URL - http://ctri.nic.in
page 3 / 6