Vaginal Infection Study - Full Text View

Sponsor:	KV Pharmaceutical Company
Information provided by:	KV Pharmaceutical Company
ClinicalTrials.gov Identifier:	NCT00616330

Purpose

This study will evaluate the efficacy and safety of a vaginal product compared with that of other vaginal products and placebo in the treatment of vaginal infections.

Condition	Intervention	Phase
Vulvovaginitis Vaginitis	Drug: clindamycin phosphate/butoconazole nitrate Drug: clindamycin phosphate Drug: butoconazole nitrate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Resource links provided by NLM:

Drug Information available for: Clindamycin Clindamycin hydrochloride Clindamycin phosphate Clindamycin Palmitate Hydrochloride Clindamycin palmitate Butoconazole Butoconazole nitrate

U.S. FDA Resources

Further study details as provided by KV Pharmaceutical Company:

Primary Outcome Measures:

The primary outcome measure of the study will be clinical symptom resolution. [ Time Frame: baseline, 7 to 10 days and 21 to 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary outcome measures will include laboratory assessments of presence or absence of vaginal infection. [ Time Frame: baseline, 7 to 10 days and 21 to 30 days ] [ Designated as safety issue: No ]

Enrollment:	1443
Study Start Date:	January 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental clindamycin phosphate/butoconazole nitrate	Drug: clindamycin phosphate/butoconazole nitrate semi solid, single dose
2: Active Comparator clindamycin phosphate	Drug: clindamycin phosphate semi solid, single dose
3: Active Comparator butoconazole nitrate	Drug: butoconazole nitrate semi solid, single dose

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have a clinical diagnosis of vaginal infection.
Patients must be post-menopausal, surgically sterilized or using an acceptable form of birth control.

Exclusion Criteria:

Patients must not have any other infections
May not be pregnant or nursing
May not be receiving any other antimicrobial therapies or any medications that would interfere with the outcome of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616330

Show 133 Study Locations

Sponsors and Collaborators

KV Pharmaceutical Company

Investigators

Study Director:

Chang Lee, MD

KV Pharmaceutical Company

More Information

No publications provided

Responsible Party:	KV Pharmaceutical Company ( Chang Lee, MD, Vice President Clinical and Medical Affairs )
Study ID Numbers:	CBC-302-602-622467
Study First Received:	February 4, 2008
Last Updated:	October 20, 2009
ClinicalTrials.gov Identifier:	NCT00616330 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Vulvovaginitis
Clindamycin
Clindamycin-2-phosphate
Molecular Mechanisms of Pharmacological Action
Vaginitis
Butoconazole
Vaginal Diseases
Enzyme Inhibitors

Pharmacologic Actions
Genital Diseases, Female
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Antifungal Agents
Therapeutic Uses
Vulvitis
Vulvar Diseases

ClinicalTrials.gov processed this record on February 08, 2010