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Comparison of Two Topical Formulations Containing Clindamycin and Clotrimazole in Patients With Vaginal Infections

Primary Purpose

Vaginal Infections

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
ClinSupV3 -soft gelatin capsule
ClinSupV3ER- Extended release tablet
Sponsored by
Dr Bharti Daswani
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginal Infections focused on measuring Clindamycin, Clotrimazole, Vaginal formulation, Bacterial vaginosis, Candidiasis, Trichomoniasis, Mixed vaginitis, Infective vaginitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women with symptoms of vaginal discharge and/or odor and a clinical diagnosis of vaginitis of infective origin [based on symptoms and signs on per speculum examination]
  • Age at least 18 years
  • Capable of giving written informed consent
  • Agree to no intercourse for 8 days from the day of start of treatment
  • Agree not to douche or use any intravaginal products during the study period (including tampons, medications and devices)

Exclusion Criteria:

  • Post-menopausal women
  • Menstruating at diagnosis
  • Pregnancy
  • Any antifungal or antibiotic use 14 days prior to enrolment
  • Use of oral or intravaginal antibiotics within the past 2 weeks
  • Immunosuppressive drug within 4 months
  • Presence of vaginal / vulval ulcer
  • Presence of any other vulval, vaginal or medical condition, including cervical neoplasia/ treatment that might confound treatment response
  • Inability to keep return appointments
  • History of hypersensitivity to clotrimazole, clindamycin or lincomycin
  • History of regional enteritis, ulcerative colitis or antibiotic associated colitis
  • Significant disease or acute illness that in the Investigators assessment could complicate the evaluation
  • Intrauterine Device

Sites / Locations

  • BJ Govt. Medical College & Sassoon General Hospitals, Pune

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ClinSupV3 -soft gelatin capsule

ClinSupV3ER- Extended release tablet

Arm Description

Soft gelatin capsule containing 100mg Clindamycin and 200mg clotrimazole administered per vaginally for 3 consecutive days

ER tablets containing 100mg clindamycin and 200mg clotrimazole administered per vaginally for 3 consecutive days.

Outcomes

Primary Outcome Measures

Primary outcome measure for Global effectiveness
Number of patients showing resolution of clinical signs suggestive of infective vaginitis and a vaginal swab that is negative for bacterial, trichomonal or candidal vaginitis

Secondary Outcome Measures

Secondary outcome measures for Global effectiveness
Number of patients showing absence of clinical signs suggestive of infective vaginitis and a vaginal swab that is negative for bacterial,trichomonal or candidal vaginitis
Secondary outcome measures for tolerability
Number of patients that are able to successfully complete the 3 day treatment course without a break or experiencing intolerable side-effects

Full Information

First Posted
September 29, 2012
Last Updated
October 1, 2012
Sponsor
Dr Bharti Daswani
Collaborators
Resilient Cosmeceuticals Pvt. Ltd, Pune
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1. Study Identification

Unique Protocol Identification Number
NCT01697826
Brief Title
Comparison of Two Topical Formulations Containing Clindamycin and Clotrimazole in Patients With Vaginal Infections
Official Title
A Comparative Open Labeled Clinical Study to Evaluate the Efficacy and Tolerability of Two Different Intravaginal Formulations Containing a Combination of Clindamycin and Clotrimazole in Vaginal Infections
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr Bharti Daswani
Collaborators
Resilient Cosmeceuticals Pvt. Ltd, Pune

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Randomized, Parallel Group, Active Controlled Trial to compare effectiveness and tolerability of 2 different vaginal formulations containing 200mg clotrimazole and clindamycin phosphate equivalent to 100mg clindamycin for 3 days in women clinically diagnosed to have infective vaginitis.
Detailed Description
This is a Randomized, Comparative, Prospective, Open label, Single center study to compare the 3 day treatment course of intravaginal soft gelatin capsule containing clindamycin and clotrimazole versus intravaginal ER tablets of clindamycin and clotrimazole in patients with vaginal discharge and clinical diagnosis of bacterial, trichomonal, candidal or mixed vaginitis with respect to efficacy and tolerability; and to study the in vitro drug release pattern of intravaginal soft gelatin capsule and intravaginal ER tablets containing clindamycin and clotrimazole. The study will be conducted in B.J. Medical College & Sassoon General Hospitals, Pune. The study will be completed in 60 patients [30 patients in each group]. The primary outcome measure is absence of any clinical sign suggestive of infective vaginitis and a vaginal swab that is negative for bacterial, trichomonal or candidal vaginitis at 8th day after start of treatment [Effectiveness in inducing a remission]. The secondary outcome measures will be absence of any clinical sign suggestive of infective vaginitis and a vaginal swab that is negative for bacterial, trichomonal or candidal vaginitis at 29th day after start of treatment [Effectiveness in maintaining a remission] and ability to complete the 3day course without any break or experiencing intolerable side effects [Tolerability].

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Infections
Keywords
Clindamycin, Clotrimazole, Vaginal formulation, Bacterial vaginosis, Candidiasis, Trichomoniasis, Mixed vaginitis, Infective vaginitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ClinSupV3 -soft gelatin capsule
Arm Type
Active Comparator
Arm Description
Soft gelatin capsule containing 100mg Clindamycin and 200mg clotrimazole administered per vaginally for 3 consecutive days
Arm Title
ClinSupV3ER- Extended release tablet
Arm Type
Active Comparator
Arm Description
ER tablets containing 100mg clindamycin and 200mg clotrimazole administered per vaginally for 3 consecutive days.
Intervention Type
Drug
Intervention Name(s)
ClinSupV3 -soft gelatin capsule
Other Intervention Name(s)
Clindamycin plus Clotrimazole
Intervention Description
3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg clotrimazole
Intervention Type
Drug
Intervention Name(s)
ClinSupV3ER- Extended release tablet
Other Intervention Name(s)
Clindamycin plus Clotrimazole
Intervention Description
3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg Clotrimazole
Primary Outcome Measure Information:
Title
Primary outcome measure for Global effectiveness
Description
Number of patients showing resolution of clinical signs suggestive of infective vaginitis and a vaginal swab that is negative for bacterial, trichomonal or candidal vaginitis
Time Frame
On 8th day after start of treatment
Secondary Outcome Measure Information:
Title
Secondary outcome measures for Global effectiveness
Description
Number of patients showing absence of clinical signs suggestive of infective vaginitis and a vaginal swab that is negative for bacterial,trichomonal or candidal vaginitis
Time Frame
29th day after initiation of treatment
Title
Secondary outcome measures for tolerability
Description
Number of patients that are able to successfully complete the 3 day treatment course without a break or experiencing intolerable side-effects
Time Frame
8th day after start of treatment
Other Pre-specified Outcome Measures:
Title
Clinical Response
Description
Number of the patients showing normalization of vaginal pH to 4.5
Time Frame
at 8th day and 29th day after initiation of treatment
Title
Clinical response
Description
Number of the patients achieving improvement in scores for quantity of vaginal discharge by at least 1 unit from baseline
Time Frame
at 8th and 29th day after start of treatment
Title
Clinical response
Description
Number of the patients achieving improvement in scores for itching by at least 1 unit from baseline
Time Frame
at 8th day and 29th day after start of treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women with symptoms of vaginal discharge and/or odor and a clinical diagnosis of vaginitis of infective origin [based on symptoms and signs on per speculum examination] Age at least 18 years Capable of giving written informed consent Agree to no intercourse for 8 days from the day of start of treatment Agree not to douche or use any intravaginal products during the study period (including tampons, medications and devices) Exclusion Criteria: Post-menopausal women Menstruating at diagnosis Pregnancy Any antifungal or antibiotic use 14 days prior to enrolment Use of oral or intravaginal antibiotics within the past 2 weeks Immunosuppressive drug within 4 months Presence of vaginal / vulval ulcer Presence of any other vulval, vaginal or medical condition, including cervical neoplasia/ treatment that might confound treatment response Inability to keep return appointments History of hypersensitivity to clotrimazole, clindamycin or lincomycin History of regional enteritis, ulcerative colitis or antibiotic associated colitis Significant disease or acute illness that in the Investigators assessment could complicate the evaluation Intrauterine Device
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bharti R Daswani, MD, PhD
Organizational Affiliation
BJ Govt Medical College & Sassoon General Hospitals, Pune
Official's Role
Principal Investigator
Facility Information:
Facility Name
BJ Govt. Medical College & Sassoon General Hospitals, Pune
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India

12. IPD Sharing Statement

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Comparison of Two Topical Formulations Containing Clindamycin and Clotrimazole in Patients With Vaginal Infections

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