CTRI Number |
CTRI/2014/02/004409 [Registered on: 17/02/2014] Trial Registered Prospectively |
Last Modified On: |
21/11/2018 |
Post Graduate Thesis |
No |
Type of Trial |
PMS |
Type of Study
|
Drug |
Study Design |
Single Arm Study |
Public Title of Study
|
Assessment of efficacy and safety of Lipid based Amphotericin B gel 0.1% (Amfy gel®) in patients with moderate to severe vulvovaginal candidiasis |
Scientific Title of Study
|
A prospective, open label, multicenter clinical trial to assess efficacy and safety of Lipid based Amphotericin B gel 0.1% (Amfy gel®) in patients with moderate to severe vulvovaginal candidiasis after treatment failure with anti-fungal azoles. |
Trial Acronym |
NA |
Secondary IDs if Any
|
Secondary ID |
Identifier |
671-13_version01_dated06/12/2013 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Mr Harshit Shah |
Designation |
Assistant Project Manager |
Affiliation |
Lambda Therapeutic Research Ltd |
Address |
Plot No. 38, Near Silver Oak Club S. G. Highway, Gota Ahmadabad GUJARAT 380061 India |
Phone |
07940202020 |
Fax |
07940202021 |
Email |
harshitshah@lambda-cro.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Arpit K Prajapati |
Designation |
Assistant Manager |
Affiliation |
Lambda Therapeutic Research Ltd |
Address |
Plot No. 38, Near Silver Oak Club S. G. Highway, Gota Ahmadabad GUJARAT 380061 India |
Phone |
07940202020 |
Fax |
07940202021 |
Email |
arpitkprajapati@lambda-cro.com |
|
Details of Contact Person Public Query
|
Name |
Dr Arpit K Prajapati |
Designation |
Assistant Manager |
Affiliation |
Lambda Therapeutic Research Ltd |
Address |
Plot No. 38, Near Silver Oak Club S. G. Highway, Gota
GUJARAT 380061 India |
Phone |
07940202020 |
Fax |
07940202021 |
Email |
arpitkprajapati@lambda-cro.com |
|
Source of Monetary or Material Support
|
Intas pharmaceuticals Ltd. |
|
Primary Sponsor
|
Name |
Intas Pharmaceuticals Ltd |
Address |
2nd Floor, Chinubhai Centre, Ashram Road, Ahmedabad 380-009, Gujarat,
India
|
Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 5 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Purvi M Dave |
Anand Multispeciality Hospital Pvt Ltd |
White House, Opp. Rajasthan Hospital, Shahibaug, 380004 Ahmadabad GUJARAT |
079-22868681
drmdave@gmail.com |
Dr Dilip Walke |
Medipoint Hospitals Pvt. Ltd |
Medipoint Hospitals Pvt. Ltd, 241/1, New D.P. Road, Aundh, 411007 Pune MAHARASHTRA |
020-27298081
dbwalke@hotmail.com |
Dr Shushil Shirish Chaudhari |
Muktai Hospital |
11 Shivaji Nagar, Opp. Fame Adlabs, Nashik Road,422006 Nashik MAHARASHTRA |
0253-2422480
sdrsushil@gmail.com |
Dr Jagruti Desa |
Nirmal Hospital Pvt Ltd, |
Ring Road, Civil Street, Near Kadiwala School,395002 Surat GUJARAT |
0261-2333999
drjagrutiydesai@gmail.com |
Dr Mamta Bhomia |
Sanjivani Superspeciality hospital |
1, Uday Park Soc, Near Sunrise park, Vastrapur,380015 Ahmadabad GUJARAT |
079-26300411
mvb3.sanjivani@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 5 |
Name of Committee |
Approval Status |
Anand Institutional Ethics Committee, Ahmedabad (Dr. Purvi M. Dave) |
Approved |
Muktai Hospital Ethics committee, Nashik (Dr. Sushil Shirish Chaudhari) |
Approved |
Nirmal Hospital Pvt Ltd Ethics committee, Surat (Dr. Jagruti Desai) |
Approved |
Pentamed Ethics Committee, Pune (Dr. Dilip Walke) |
Approved |
Sanjivani Hospital Ethics Committee, Ahmedabad (Dr. Mamta Bhomia) |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: B373||Candidiasis of vulva and vagina, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Amfy gel |
Dose-0.1%
Frequency-twice daily
Mode of Administration-topical
Duration of treatment-14 days
|
Comparator Agent |
NA |
NA |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Female |
Details |
1. Female patients’ ≥18 years of age, on an acceptable form of birth control throughout treatment period.
2. The patient willing to give written, signed and dated informed consent to participate in the study before initiating any study related procedure.
3. Clinical diagnosis of symptomatic vulvovaginal candidiasis (score at screening and baseline visit ≥7 – moderately severe cases) confirmed at screening visit by positive KOH wet mount test.
4. History of completing a single standard dose or short course of treatment with anti-fungal azoles within three months of the current symptomatic episode of VVC.
5. Patient complies with all clinical trial instructions and procedures. |
|
ExclusionCriteria |
Details |
1. Pregnant or breastfeeding or planning to become pregnant during the treatment period.
2. Diagnosed with disseminated candidiasis or requires systemic antifungal therapy.
3. Has received any topical/systemic antifungal therapy within 7 days prior to visit 2 (baseline).
4. Women suffering from other active infectious cause(s) of vulvovaginitis (e.g., Bacterial vaginosis, Trichomonasvaginalis, Chlamydia trachomatis, Neisseria gonorrhea, symptomatic Herpes Simplex Virus-1 (HSV-1), symptomatic HSV-2, or symptomatic human papilloma virus).
5. Women with current use of any immunosuppressive drugs, including systemic or topical vaginal corticosteroids.
6. Known case of Hypersensitivity or intolerance (e.g., elevation of liver enzymes) to Amphotericin B.
7. Diagnosed with any concomitant condition that, in the opinion of the investigator, could interfere with the evaluation of efficacy or safety, or would make it unlikely that the patient would complete the study.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Proportion of patients with clinical cure |
At the end of 14 day course of treatment. |
|
Secondary Outcome
|
Outcome |
TimePoints |
• Any adverse event reported voluntarily, observed or enquired during the safety period
• Proportion of patients with negative KOH wet mount test at the end of 14 day course of treatment.
|
Throughout study drug administration period
(14 days)
At the end of 14 day course of treatment
|
|
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
|
Phase 4 |
Date of First Enrollment (India)
|
20/02/2014 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="4" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
NA |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Vulvovaginal candidiasis
(VVC) is a common problem in women worldwide, with 75 per cent of women experiencing
symptomatic disease at least once throughout their childbearing years.
Anti-fungal azoles, including clotrimazole, fluconazole and imidazole
administered as topical cream, vaginal pessary or oral tablets remain the
standard of care and are effectivein about 70-90% of cases. About 20% of
patients fail treatment, i.e remain symptomatic and culture positive following
a single standard dose or short course of treatment with anti-fungal azoles.
The causes for treatment failure include poor compliance, non-albicans
infection or severe disease.
Amphotericin B is a
polyene antifungal drug, often used for systemic fungal infections, produced by
Streptomyces nodosus. Amphotericin B associates with ergosterol, the main
component of fungal cell membranes, forming a transmembrane channel that leads
to monovalent ion (K+, Na+, H+ and Cl-) leakage, which is the primary effect
leading to fungal cell death. It is broad spectrum Antifungal drug and quite
effective against yeasts (Candida albicans, Candida neoformans), endemic
mycoses (Histoplasma capsulatum, Blastomyces
dermatitidis and Coccidiodes immitis) and pathogenic molds
(Aspergillus fumigatus and
Mucormycosis).
The Amfy® gel (Lipid Based
Amphotericin B Gel 0.1%) has been approved by the regulatory authorities for
marketing in India. As a part of the extended monitoring efforts to monitor the
safety and efficacy of the gel, this post marketing surveillance study is being
conducted in the patients of Vulvovaginal candidiasis. |