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

Vaginal Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697826
• Other study ID #: ND1210132-34
• Secondary ID: CTRI/2011/04/001
• Status: Completed
• Phase: Phase 4
• First received: September 29, 2012
• Last updated: October 1, 2012
• Start date: April 2011
• Est. completion date: September 2011

Study information

• Verified date: September 2012
• Source: Daswani, Bhart, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

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].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection
• Vaginal Infections

Intervention

Drug:
• ClinSupV3 -soft gelatin capsule
3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg clotrimazole
• ClinSupV3ER- Extended release tablet
3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg Clotrimazole

Locations

Country	Name	City	State
India	BJ Govt. Medical College & Sassoon General Hospitals, Pune	Pune	Maharashtra

Sponsors (2)

Lead Sponsor	Collaborator
Dr Bharti Daswani	Resilient Cosmeceuticals Pvt. Ltd, Pune

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical Response	Number of the patients showing normalization of vaginal pH to 4.5	at 8th day and 29th day after initiation of treatment	No
Other	Clinical response	Number of the patients achieving improvement in scores for quantity of vaginal discharge by at least 1 unit from baseline	at 8th and 29th day after start of treatment	No
Other	Clinical response	Number of the patients achieving improvement in scores for itching by at least 1 unit from baseline	at 8th day and 29th day after start of treatment	No
Primary	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	On 8th day after start of treatment	No
Secondary	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	29th day after initiation of treatment	No
Secondary	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	8th day after start of treatment	Yes