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

This study has been completed.
Sponsor:
Collaborator:
Resilient Cosmeceuticals Pvt. Ltd, Pune
Information provided by (Responsible Party):
Dr Bharti Daswani, Daswani, Bhart, M.D.
ClinicalTrials.gov Identifier:
NCT01697826
First received: September 29, 2012
Last updated: October 1, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Vaginal Infections
Drug: ClinSupV3 -soft gelatin capsule
Drug: ClinSupV3ER- Extended release tablet
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Daswani, Bhart, M.D.:

Primary Outcome Measures:
  • Primary outcome measure for Global effectiveness [ Time Frame: On 8th day after start of treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 29th day after initiation of treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8th day after start of treatment ] [ Designated as safety issue: Yes ]
    Number of patients that are able to successfully complete the 3 day treatment course without a break or experiencing intolerable side-effects


Other Outcome Measures:
  • Clinical Response [ Time Frame: at 8th day and 29th day after initiation of treatment ] [ Designated as safety issue: No ]
    Number of the patients showing normalization of vaginal pH to 4.5

  • Clinical response [ Time Frame: at 8th and 29th day after start of treatment ] [ Designated as safety issue: No ]
    Number of the patients achieving improvement in scores for quantity of vaginal discharge by at least 1 unit from baseline

  • Clinical response [ Time Frame: at 8th day and 29th day after start of treatment ] [ Designated as safety issue: No ]
    Number of the patients achieving improvement in scores for itching by at least 1 unit from baseline


Enrollment: 73
Study Start Date: April 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ClinSupV3 -soft gelatin capsule
Soft gelatin capsule containing 100mg Clindamycin and 200mg clotrimazole administered per vaginally for 3 consecutive days
Drug: ClinSupV3 -soft gelatin capsule
3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg clotrimazole
Other Name: Clindamycin plus Clotrimazole
Active Comparator: ClinSupV3ER- Extended release tablet
ER tablets containing 100mg clindamycin and 200mg clotrimazole administered per vaginally for 3 consecutive days.
Drug: ClinSupV3ER- Extended release tablet
3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg Clotrimazole
Other Name: Clindamycin plus Clotrimazole

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

    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].
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697826

Locations
India
BJ Govt. Medical College & Sassoon General Hospitals, Pune
Pune, Maharashtra, India, 411001
Sponsors and Collaborators
Dr Bharti Daswani
Resilient Cosmeceuticals Pvt. Ltd, Pune
Investigators
Principal Investigator: Bharti R Daswani, MD, PhD BJ Govt Medical College & Sassoon General Hospitals, Pune
  More Information

No publications provided

Responsible Party: Dr Bharti Daswani, Dr, Daswani, Bhart, M.D.
ClinicalTrials.gov Identifier: NCT01697826     History of Changes
Other Study ID Numbers: ND1210132-34, CTRI/2011/04/001698
Study First Received: September 29, 2012
Last Updated: October 1, 2012
Health Authority: India: Institutional Review Board

Keywords provided by Daswani, Bhart, M.D.:
Clindamycin
Clotrimazole
Vaginal formulation
Bacterial vaginosis
Candidiasis
Trichomoniasis
Mixed vaginitis
Infective vaginitis

Additional relevant MeSH terms:
Clotrimazole
Miconazole
Clindamycin-2-phosphate
Clindamycin
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Protein Synthesis Inhibitors
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 20, 2014