| CTRI Number |
CTRI/2022/12/048230 [Registered on: 19/12/2022] Trial Registered Prospectively |
| Last Modified On: |
06/02/2024 |
| 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 the Effect of Clotrimazole vaginal film |
|
Scientific Title of Study
|
COMPARATIVE CLINICAL EVALUATION OF EFFICACY AND SAFETY OF CLOTRIMAZOLE VAGINAL FILM VS CANESTEN V6 VAGINAL TABLET IN THE MANAGEMENT OF SYMPTOMATIC VULVOVAGINAL CANDIDIASIS IN NON PREGNANT WOMEN - OPEN LABEL, RANDOMIZED, COMPARATIVE, PARALLEL, PROSPECTIVE, MULTICENTRIC STUDY |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| HHCL/01-01/22, Version No. 1.2; Version date: 20-10-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shobha Jagdish Chandra |
| Designation |
Head of Department (HOD) |
| Affiliation |
Hetero Healthcare Limited |
| Address |
Department of Clinical Pharmacology and Therapeutics Hetero Healthcare Limited
Sy no 80 84 Melange Towers
4th floor C wing
Patrika nagar Madhapur
Hyderabad
Hyderabad
TELANGANA
500 081
India |
| Phone |
9704416425 |
| Fax |
|
| Email |
shobhaudutha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shobha Jagdish Chandra |
| Designation |
Head of Department (HOD) |
| Affiliation |
Hetero Healthcare Limited |
| Address |
Department of Clinical Pharmacology and Therapeutics Hetero Healthcare Limited
Sy no 80 84 Melange Towers
4th floor C wing
Patrika nagar Madhapur
Hyderabad
Hyderabad
TELANGANA
500 081
India |
| Phone |
9704416425 |
| Fax |
|
| Email |
shobhaudutha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr P Narender reddy |
| Designation |
Clinical Research Associate |
| Affiliation |
Hetero Healthcare Limited |
| Address |
Department of Clinical Pharmacology and Therapeutics Hetero Healthcare Limited
Sy no 80 84 Melange Towers
4th floor C wing
Patrika nagar Madhapur
Hyderabad
Hyderabad
TELANGANA
500 081
India |
| Phone |
9030343543 |
| Fax |
|
| Email |
narenderreddy.pdgla@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hetero Healthcare Limited
Sy no 80 84 Melange Towers
4th floor C wing
Patrika nagar Madhapur
Hyderabad 500 081 Telangana |
|
|
Primary Sponsor
|
| Name |
Hetero Healthcare Limited |
| Address |
Sy no 80 84 Melange Towers
4th floor C wing
Patrika nagar Madhapur
Hyderabad 500 081 Telangana |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pruthwiraj Sethi |
All India Institute of Medical Sciences |
Department of Obstetrics and Gynecolgoy,1st floor, Sujata, Patrapada, Bhubaneswar, Odisha 751019, India
Khordha
ORISSA |
9438884132
pruthwiaiims@gmail.com |
| Dr Tushar Tatyava Palve |
Cama and Albless Hospital |
Department of Gynecology, BMC office Mahapalika marg opp. Azad Maidan, Dhobi Talao Chhatrapati Shivaji Terminus Area, Fort, Mumbai, 400001, Maharastra, India
Mumbai
MAHARASHTRA |
9029293828
atpforever2000@yahoo.co.in |
| Dr Girija BS |
Hassan Institute of Medical Sciences |
Department of Obstetrics and
Gynecology, Room No. 27, Ground floor, Sri Chamarajendra Hospital Campus, Krishnaraja Pura, Hassan, Karnataka 573201, India
Hassan
KARNATAKA |
9945462077
girijaprasannaobg@gmail.com |
| Dr A Srilakshmi |
Kurnool Medical college |
Department of Obstetrics and Gynecology, 4th floor, Room No 2, Budhawara Peta, Kurnool-518002, Andhra Pradesh, India
Kurnool
ANDHRA PRADESH |
8500228571
srilakshmiambarkar@gmail.com |
| Dr Adhav Tejasvini Kishor |
Life Point Multispecialty Hospital |
Clinical Research Department, 3rd floor, 145/1, Mumbai Banglore Highway, Near Hotel Sayaji, Wakade, Pune-411057, Maharastra, India
Pune
MAHARASHTRA |
8805785212
adhav.tejasvini121@gmail.com |
| Dr Malathi Verabelly |
Malla Reddy Hospital |
Mallareddy Clinical Research Unit (MRCRU),Room No. 2A2, 2nd floor, L Shape building, Jeedimetla, Suraram,
Hyderabad- 500055, Telangana, India
Hyderabad
TELANGANA |
9291279091
malathi1174@gmail.com |
| Dr Rachakonda Laxmi Nagbhushanam |
MGM Medical College and Hospital |
Department of Clinical Pharmacology and Therapeutics,
clinical trial centre MGM Medical college and Hospital, N-6 CIDCO, Aurangabad-431003,
Maharashtra, India
Aurangabad
MAHARASHTRA |
9823018558
dr.rachakondalakshmi@gmail.com |
| Dr Ponnuru Malathi |
Modern Government Maternity Hospital |
Department of Obstetrics and Gynecology, 2nd floor, Petlaburj,
Hyderabad -500064, Telanagna, India
Hyderabad
TELANGANA |
9949362504
malathiponnuru@gmail.com |
| Dr Krishnendu Goswami |
NRS Medical College and Hospital |
Department of Obstetrics & Gynaecology, NRS Medical College and hospital, 138 AJC Bose Road, Sealdah, Raja Bazar, Kolkata, West bengal 700014, India
Kolkata
WEST BENGAL |
8420567640
nrskrishnendu@gmail.com |
| Dr Ashok Kumar |
Vani Vilas Hospital |
Department of Obstetrics and gynecology, Room No. 29, Ground floor, Victoria Hospital, Mysore Rd, near City Market, New Tharagupet, Bengaluru, Karnataka 560002, India
Bangalore
KARNATAKA |
9964195445
drashok2008@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Ethics Committee Of BMCRI |
Approved |
| Ethics Committee, N.R.S. Medical College |
Approved |
| Institutional Ethics Committee , GGMC, Mumbai |
No Objection Certificate |
| Institutional Ethics Committee – HIMS, Hassan |
Approved |
| Institutional Ethics Committee Kurnool medical college/government general hospital |
Approved |
| Institutional Ethics Committee MRIMS |
Approved |
| Institutional Ethics Committee, AIIMS Bhubaneswar |
Approved |
| Institutional Ethics committee, Osmania Medical college |
Approved |
| Lifepoint Research- Ethics Committee |
Approved |
| MGM Ethics Committee For Research On Human Subject |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
| Status |
| No Objection Certificate |
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N899||Noninflammatory disorder of vagina, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Canesten V6 vaginal tablet |
Dose:One Canesten V6 vaginal tablet
Route of administration :Intravaginally
Frequency: One tablet during night time for 7 days.
|
| Intervention |
Clotrimazole vaginal film |
Dose: Two clotrimazole vaginal films (50mg each)
Route of administration: Intravaginally
Frequency: Two films during night time for 7days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Women aged 18 to 45 years with clinical diagnosis of symptomatic vulvovaginal candidiasis.
2. Subjects with positive baseline potassium hydroxide (KOH) wet mount from a vaginal smear revealing filamentous hyphae / pseudo hyphae or budding yeast cells.
3. Presence of > 1 vulvovaginal sign (erythema, edema, excoriation), presence of > 1 vulvovaginal symptom (itching / pruritus, irritation in and around vagina, burning); composite severity score of > 6.
4. Patients with negative whiff test.
5. Patients with vaginal pH < 4.5.
6. Agree to abstain from intercourse during the study period.
7. Agree not to douche or use any intravaginal products during the study period.
8. Willing to report response to treatment as per protocol during the study period.
9. Willing to give written informed consent |
|
| ExclusionCriteria |
| Details |
1. Post-menopausal women
2. Menstruating at diagnosis
3. Pregnancy or nursing mothers
4. Use of intravaginal pessaries, immune suppressive therapy in the last 2 weeks.
5. Presence of another vaginal condition, cervical cancer.
6. H/O hypersensitivity to study medication, serious illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
- Proportion of patients with clinical cure - defined as complete resolution of signs and symptoms pertaining to VVC at the end of day 7 in each treatment group.
- Proportion of patients with mycological cure – negative potassium hydroxide (KOH) wet mount from vaginal smear for filamentous hyphae / pseudo hyphae or budding yeast cells at the end of day 7 in each treatment group.
- Proportion of patients with Therapeutic cure – defined as clinical and mycological cure at end of day 7 in each treatment group. |
Day 3,7,14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Treatment Emergent Adverse Events |
Day 3, 7, 14 |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "300"
Final Enrollment numbers achieved (India)="300" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
15/02/2023 |
| Date of Study Completion (India) |
19/12/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicalbe |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is an Open Label, Randomized, Comparative, Parallel, Prospective, Multicentric study. The primary objective of this is to evaluate the clinical efficacy of Clotrimazole Vaginal film as compared to Canesten V6 vaginal tablet in the management of symptomatic vulvovaginal candidiasis in non pregnant women. The Secondary objective of this trial is to assess the safety of Clotrimazole vaginal film as compared to Canesten V6 vaginal tablet in the management of symptomatic vulvovaginal candidiasis in non pregnant women. Duration of therapy is 7 days, safety follow up will be conducted up to day 14. |