Vaginal Infection Study 2 - Full Text View

Sponsored by:	KV Pharmaceutical Company
Information provided by:	KV Pharmaceutical Company
ClinicalTrials.gov Identifier:	NCT00694928

Purpose

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

Condition	Intervention	Phase
Vaginal Infection	Drug: clindamycin phosphate/butoconazole nitrate Drug: butoconazole nitrate	Phase III

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

U.S. FDA Resources

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

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 ]

Estimated Enrollment:	500
Study Start Date:	May 2008
Estimated Primary Completion Date:	May 2010 (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 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: NCT00694928

Contacts

Contact: Chang Lee, MD

877-567-7676

Show 29 Study Locations

Sponsors and Collaborators

KV Pharmaceutical Company

Investigators

Study Director:

Chang Lee, MD

KV Pharmaceutical Company

More Information

Responsible Party:	KV Pharmaceutical Company ( Chang Lee, MD, Vice President Clinical and Medical Affairs )
Study ID Numbers:	CBC-303-603-622467
Study First Received:	June 9, 2008
Last Updated:	November 3, 2008
ClinicalTrials.gov Identifier:	NCT00694928
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Clindamycin
Clindamycin-2-phosphate
Clotrimazole

Miconazole
Butoconazole
Tioconazole

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Communicable Diseases
Molecular Mechanisms of Pharmacological Action

Antifungal Agents
Therapeutic Uses
Enzyme Inhibitors
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009