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

NCT ID: NCT01697826

Last Updated: 2012-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-09-30

Brief Summary

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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

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* 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

1. absence of any clinical sign suggestive of infective vaginitis and
2. 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 \[Tolerability\].

Conditions

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Vaginal Infections

Keywords

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Clindamycin Clotrimazole Vaginal formulation Bacterial vaginosis Candidiasis Trichomoniasis Mixed vaginitis Infective vaginitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ClinSupV3 -soft gelatin capsule

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

Group Type ACTIVE_COMPARATOR

ClinSupV3 -soft gelatin capsule

Intervention Type DRUG

3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg clotrimazole

ClinSupV3ER- Extended release tablet

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

Group Type ACTIVE_COMPARATOR

ClinSupV3ER- Extended release tablet

Intervention Type DRUG

3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg Clotrimazole

Interventions

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ClinSupV3 -soft gelatin capsule

3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg clotrimazole

Intervention Type DRUG

ClinSupV3ER- Extended release tablet

3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg Clotrimazole

Intervention Type DRUG

Other Intervention Names

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Clindamycin plus Clotrimazole Clindamycin plus Clotrimazole

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Resilient Cosmeceuticals Pvt. Ltd, Pune

UNKNOWN

Sponsor Role collaborator

Dr Bharti Daswani

INDIV

Sponsor Role lead

Responsible Party

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Dr Bharti Daswani

Dr

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Bharti R Daswani, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

BJ Govt Medical College & Sassoon General Hospitals, Pune

Locations

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BJ Govt. Medical College & Sassoon General Hospitals, Pune

Pune, Maharashtra, India

Site Status

Countries

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India

Other Identifiers

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CTRI/2011/04/001698

Identifier Type: REGISTRY

Identifier Source: secondary_id

ND1210132-34

Identifier Type: -

Identifier Source: org_study_id