Vaginal Infection Study 2 - Full Text View

Sponsor:	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
Vaginitis	Drug: clindamycin phosphate/butoconazole nitrate Drug: butoconazole nitrate	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

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:

Clinical symptom resolution [ Time Frame: baseline, 7 to 10 days and 21 to 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Yeast Culture for Candida [ Time Frame: baseline, 7 to 10 days and 21 to 30 days ] [ Designated as safety issue: No ]
Negative Yeast Culture for Candida result=response, Positive Yeast Culture for Candida result=no response
Gram Stain Nugent Score [ Time Frame: baseline, 7 to 10 days and 21 to 30 days ] [ Designated as safety issue: No ]
Gram stain Nugent score of less than 4= resolution, Gram stain Nugent score of greater than 4= no resolution
Saline wet mount for clue cells [ Time Frame: baseline, 7 to 10 days and 21 to 30 days ] [ Designated as safety issue: No ]
Saline wet mount negative for clue cells=resolution, Saline wet mount positive for clue cells=no resolution

Enrollment:	843
Study Start Date:	May 2008
Study Completion Date:	November 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

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

Show 73 Study Locations

Sponsors and Collaborators

KV Pharmaceutical Company

Investigators

Study Director:

Chang Lee, MD

KV Pharmaceutical Company

More Information

No publications provided

Responsible Party:	Chang Lee, MD, Vice President Clinical and Medical Affairs, KV Pharmaceutical Company
ClinicalTrials.gov Identifier:	NCT00694928 History of Changes
Other Study ID Numbers:	CBC-303-603-622467
Study First Received:	June 9, 2008
Last Updated:	January 27, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Vaginitis
Vaginal Diseases
Genital Diseases, Female
Clindamycin
Clindamycin-2-phosphate
Butoconazole
Protein Synthesis Inhibitors

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antifungal Agents

ClinicalTrials.gov processed this record on February 09, 2012