| CTRI Number |
CTRI/2010/091/000238 [Registered on: 26/07/2010] |
| Last Modified On: |
25/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to study the effects of Metronidazole gel (Zydus) Versus MetroGel-Vaginal® of Graceway Pharmaceuticals, in the treatment of patients with bacterial vaginosis. |
Scientific Title of Study
Modification(s)
|
A multicentric, prospective, double-blind, randomized, parallel group study to compare the efficacy, tolerability and safety of Metronidazole gel 0.75% (Zydus) with Metronidazole vaginal gel 0.75% (MetroGel-Vaginal® ) of Graceway Pharmaceuticals, LLC in the treatment of bacterial vaginosis. |
| Trial Acronym |
METVG.009.001.02 |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| METVG.09.001.02.PROT |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr RH Jani |
| Designation |
Senior Vice President |
| Affiliation |
Cadila Healthcare Limited |
| Address |
Zydus Cadila House
Plot No 360 TPS 5 Service Road Vile Parle East
Mumbai
MAHARASHTRA
400057
India |
| Phone |
91226186057 |
| Fax |
91226151735 |
| Email |
rhjani@zyduscadila.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr RH Jani |
| Designation |
Sr V P |
| Affiliation |
Cadila Healthcare Limited |
| Address |
Zydus Cadila House
Plot No 360, TPS 5 Service Road Vile Parle (East)
Mumbai
MAHARASHTRA
400057
India |
| Phone |
91226186057 |
| Fax |
91226151735 |
| Email |
rhjani@zyduscadila.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr R H Jani |
| Designation |
Sr. Vice President, Clinical R&D |
| Affiliation |
Cadila Healthcare Limited |
| Address |
Zydus Cadila House
Plot No 360 TPS 5 Service Road, Vile Parle East
Mumbai
MAHARASHTRA
400057
India |
| Phone |
91226186057 |
| Fax |
91226151735 |
| Email |
rhjani@zyduscadila.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Zydus Pharmaceuticals (USA) Inc |
|
Primary Sponsor
Modification(s)
|
| Name |
Cadila Healthcare Limited |
| Address |
Cadila Healthcare Ltd. Satelite Road Ahmedabad, gujarat |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kanan Avinash Yelikar |
Government Medical College |
Department of Obstetrics & Gynecology,Panchakki Road -431001
Aurangabad
BIHAR |
09823270103
drkanany@yahoo.co.in |
| Dr Manju Shukla |
K.K. Hospital |
187/88, Nabi Bullah Road,River Bank Colony-226018
Lucknow
UTTAR PRADESH |
0522 2619049
sukladrmanju@rediffmail.com |
| Dr Namita Agrawal |
Life Care Hospital |
Cons. Gynaecologist & Medical Director,98, Cantt Road-226001
Lucknow
UTTAR PRADESH |
0522 5537766
lch_lko@yahoo.co.in |
| Dr Viraj Jaiswal |
Mayo Hospital |
Sultania Road,Opp. SBI-463120
Bhopal
MADHYA PRADESH |
0755 2548094
mayohospital@yahoo.com |
| Dr BI Patel |
Shreeji Hospital |
Meghaninagar
Ahmadabad
GUJARAT |
09825010718
bipatel1@hotmail.com |
| Dr P M Gopinath |
Sooriya Hospital |
1/1, Arunachalam Road,Saligramam-600093
Chennai
TAMIL NADU |
044 427366590
dgopinath@yahoo.com |
| Dr Shashi Arora |
Yashoda Super Speciality Hospital |
H-1, Kaushambi,-201010
Ghaziabad
UTTAR PRADESH |
0120-2777841
drshashi_arora@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 28 |
| Name of Committee |
Approval Status |
| Bina Bhatt,Independent Ethics Committee,Ahmedabad |
Approved |
| Dr Jignesh Shah,Independent Ethics committee,Aditya |
Approved |
| Dr Manju Shukla,Independent Ethics committee,Aditya |
Approved |
| Dr P M Gopinath,Independent Ethics committee ,Aditya |
Approved |
| Dr Poornima M,Ethics committee of st Marthas hospital |
Approved |
| Dr Rajeshwari Patil,Independent ethics committee,Aditya |
Approved |
| Dr Rekha Bhandari ,Independent Ethics committtee Aditya |
Approved |
| Dr Rekha Khandelwal,Independent Ethics committee,Aditya |
Approved |
| Dr Shahsi Arora,Independent Ethics committee,Aditya |
Approved |
| Dr Sheela Mane ,Independent Ethics commiteee,Aditya |
Approved |
| Dr Vinita Agarwal,Independent Ethics Committee,Aditya |
Approved |
| Dr. Jyoti Unni,Jahangir Clinical development centre Ethics Committee |
Approved |
| Dr. Mukesh Chandra,Independent Ethics Committee-Aditya |
Approved |
| Dr.C P Sudha, Institutional Ethics Committee of Kempegowda Institue of medical sciences |
Approved |
| Dr.Chandravati, Independent Ethics Commitee Aditya-Ahmedabad |
Approved |
| Dr.Chandrika,Independent Ethics Committee-Aditya,Ahmedabad |
Approved |
| Dr.Dilip Kamath,Nirmaya Hospital Ethics Committee |
Approved |
| Dr.K Nagasundri,Independent Ethics Committee Aditya-Ahmedabad |
Approved |
| Dr.Kanan Yelikar,Instituional Ethics Committee,Govt Medical College,Aurangabad |
Approved |
| Dr.Kurus Koyaji,KEM hospital Research centre |
Approved |
| Dr.Mahinder Ahuja,Independent Ethics Committee,Aditya-Ahmedabad |
Approved |
| Dr.Manju Jilla,Jilla Hospital Human Ethics Committee |
Approved |
| Dr.Meenakshi Rakolia,Independent Ethics Committe-Aditya-Ahmedabad |
Approved |
| Dr.N Sundri,M.S Ramiah Medical College and Teaching hospital and Ethical review board |
Approved |
| Dr.Namita Agarwal,Independent Ethics Committe-Aditya,Ahmedabad |
Approved |
| Dr.Nivedita Pawar,Independent Ethics committee,Aditya-Ahmedabad |
Approved |
| Jagdip Shah,Pioneer independent Ethics Committe |
Approved |
| Jayesh Amin,Indepenent Ethics Committe Aditya-Ahmedabad |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Bacterial vaginosis, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
MetroGel-Vaginal® gel (Graceway Pharmaceuticals, LLC), 0.75% |
5g containing approximately 37.5 mg of metronidazole once daily at bedtime for 5 consecutive days.
Intravaginal
|
| Intervention |
Metronidazole vaginal gel (Zydus), 0.75% |
5g containing approximately 37.5 mg of metronidazole once daily at bedtime for 5 consecutive days.
Intravaginal
|
| Comparator Agent |
Placebo |
5g of placebo once daily at bedtime for 5 consecutive days. Intravaginal |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Subjects must provide the written informed consent prior to any study related procedure being performed.
2. Subjects must be 18 years of age or older with no known medical conditions that, in the investigator?s opinion, may interfere with study participation.
3. Women of childbearing potential must have a negative urine pregnancy test result upon entry into the study.
4. Subjects must agree to abstain from sexual intercourse throughout the first seven days of the study. Following the first 7 days, subjects must agree to use adequate contraceptive measures except using lubricated condom when engaging in sexual intercourse.
5. Subjects must agree to refrain from the use of intra-vaginal products throughout the study (e.g., douches, feminine deodorant sprays, spermicides, lubricated condoms, tampons, and diaphragms).
6. Women with regular menstruation and visiting the trial centre from 5th day to 20th day of the cycle or post menopausal women (defined as women with absence of menstruation for at least last 1 year), or women with surgical menopause (oophorectomy, hysterectomy)
7. Subjects must be willing to abstain from alcohol ingestion during first seven days of the study.
8. Female subjects must have a clinical diagnosis of bacterial vaginosis satisfying the following criteria:
a) Off-white, thin, homogeneous discharge with little if any inflammation
b) pH of vaginal fluid greater than 4.5, using pH paper that measures from 4.0 to 6.0
c) Positive ?whiff? test for amine odour after addition of 10% KOH
d) More than or equal to 20% Clue cells of the total epithelial cells on microscopic examination of the saline ?wet mount?
A Gram?s stain slide with Nugent score more than equal to 4
|
|
| ExclusionCriteria |
| Details |
1. Known or suspected nonbacterial causes of vulvovaginitis (e.g., candidiasis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, active Herpes simplex, or human papilloma virus, or any other vaginal or vulvar condition, which in the investigator?s opinion, would confound the interpretation of clinical response).
2. Subject with history of menstrual irregularity in last 3 months.
3. Receipt of antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days prior to dosing.
4. Receipt of disulfiram within 14 days prior to dosing.
5. Previous hypersensitivity reaction to metronidazole in any form or to any form of parabens.
6. History of significant hepatic and/or renal insufficiency
7. Subjects with history of gastrointestinal disease using cimetidine or with history of mental illness using lithium.
8. History of significant cardiovascular disorders
9. History of primary or secondary immunodeficiency.
10. Plans to be treated during the study period for cervical intra-epithelial neoplasia (CIN) or cervical carcinoma.
11. Pregnant, nursing mothers or any subject planning a pregnancy within the next 2 months.
12. Concurrent anticoagulation therapy with Coumadin (e.g. warfarin).
13. Concurrent use of systemic corticosteroids or systemic antibiotics.
14. Participation in another clinical trial or having taken an experimental drug within 30 days prior to the study entry.
15. Unwilling or unable to comply with the protocol requirements. |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Pre-numbered or coded identical Containers |
Blinding/Masking
Modification(s)
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The primary efficacy endpoint is the therapeutic cure, which requires both clinical cure and Nugent score of 0-3 at test of cure visit |
21-30 days |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
The secondary efficacy endpoints are
a)Clinical cure rate
b)Nugent score on Gram stain
i.Nugent score less then 4 is bacteriological cure
ii.Nugent score ≥ 4 is bacteriological failure
c)Time to resolution of symptoms
|
21-30 days |
|
Target Sample Size
Modification(s)
|
Total Sample Size="670"
Sample Size from India="670"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
01/02/2011 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
Publication Details
Modification(s)
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This will be a multicentre, double-blind, randomized, parallel group study to compare the efficacy, tolerability and safety of Metronidazole gel 0.75% (Zydus) with MetroGel-Vaginal® Gel, 0.75% (Graceway Pharmaceuticals, LLC) in the treatment of bacterial vaginosis. |