Comparative Study of Efficacy of 10 mg Dequalinium Chloride (Fluomizin) in the Local Treatment of Bacterial Vaginosis | RxWiki

Comparative Study of Efficacy of 10 mg Dequalinium Chloride (Fluomizin) in the Local Treatment of Bacterial Vaginosis

Overview[ - collapse ][ - ]

Purpose	The purpose of this clinical study was to evaluate whether vaginal tablets containing 10 mg dequalinium chloride (Fluomizin) are comparable in clinical efficacy and safety to clindamycin vaginal cream (2%) in patients suffering from bacterial vaginosis.
Condition	Bacterial Vaginosis
Intervention	Drug: Dequalinium chloride Drug: Clindamycin
Phase	Phase 3
Sponsor	Medinova AG
Responsible Party	Medinova AG
ClinicalTrials.gov Identifier	NCT01125410
First Received	May 11, 2010
Last Updated	May 17, 2010
Last verified	May 2010

Tracking Information[ + expand ][ + ]

First Received Date	May 11, 2010
Last Updated Date	May 17, 2010
Start Date	January 2007
Estimated Primary Completion Date	February 2009
Current Primary Outcome Measures	clinical cure rate [Time Frame: 1 week (on average)] [Designated as safety issue: No]Clinical cure rate based on Amsel criteria. For cure, clue cells have to be negative and not more than one of the other criteria positive Clinical cure rate [Time Frame: 4 weeks (on average)] [Designated as safety issue: No]Clinical cure rate based on Amsel criteria, where cure was defined as clue cells being negative and not more than one of the other criteria positive
Current Secondary Outcome Measures	Treatment failure [Time Frame: 4 weeks] [Designated as safety issue: No]Treatment failures include non-responders and recurrences Incidence of ADRs [Time Frame: 4 weeks] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	Comparative Study of Efficacy of 10 mg Dequalinium Chloride (Fluomizin) in the Local Treatment of Bacterial Vaginosis
Official Title	Phase III Comparative Study of Efficacy of 10 mg Dequalinium Chloride (Fluomizin) in the Local Treatment of Bacterial Vaginosis
Brief Summary	The purpose of this clinical study was to evaluate whether vaginal tablets containing 10 mg dequalinium chloride (Fluomizin) are comparable in clinical efficacy and safety to clindamycin vaginal cream (2%) in patients suffering from bacterial vaginosis.
Detailed Description	An international, multi-center, single-blind, randomized, active-controlled study with two parallel groups in patients with bacterial vaginosis. Eligible patients were randomized to receive Fluomizin vaginal tablets for 6 days or Clindamycin vaginal cream (2%) for 7 days. Control examinations were performed 3 to 14 days and 2 to 6 weeks after the end of the therapy.
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Condition	Bacterial Vaginosis
Intervention	Drug: Dequalinium chloride Vaginal tablet, 10mg, 1 tablet daily for 6 days Drug: Clindamycin vaginal cream, 2%, once daily for 7 days
Study Arm (s)	Experimental: Dequalinium chloride 10mg Active Comparator: clindamycin vaginal cream 2%

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	321
Estimated Completion Date	February 2009
Estimated Primary Completion Date	July 2008
Eligibility Criteria	Inclusion Criteria: - Diagnosis of bacterial vaginosis - Women aged 18-55 years Exclusion Criteria: - Pregnancy or lactation - Uterine bleeding (including menstruation but not including cervical contact bleeding on sampling) or vaginal bleeding of unknown origin - Acute infections of the upper genital tract - Clinical Symptoms of a vulvovaginal Candidiasis - Use of anti-infectives (local or systemic) in the previous 14 days and/or during the study
Gender	Female
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Belgium, Czech Republic, Germany, Slovakia, Switzerland

Administrative Information[ + expand ][ + ]

NCT Number	NCT01125410
Other Study ID Numbers	Med380104
Has Data Monitoring Committee	No
Information Provided By	Medinova AG
Study Sponsor	Medinova AG
Collaborators	Not Provided
Investigators	Principal Investigator: Ernst Rainer Weissenbacher, MD Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, LMU Munich
Verification Date	May 2010

Locations[ + expand ][ + ]

AZ Imelda Ziekenhuis	Bonheiden, Belgium
AZ St. Dimpna	Geel, Belgium
AZ Ziekenhuis Oost-Limburg	Genk, Belgium
AZ Heilig Hart	Tienen, Belgium
Centrum Ambulantni gynekologie a prodnictvi	Brno, Czech Republic
Faculty Hospital Brno	Brno, Czech Republic
University Hospital Hradec Kralove	Hradec Kralove, Czech Republic
Fakultni nemocnice Na Bulovce	Prague, Czech Republic
Charles University	Prague, Czech Republic
Ambulance pro gynekologie a prodnictvi	Telc, Czech Republic
LMU Munich	Munich, Germany
JLF UK a MFN	Martin, Slovakia
University Hospital of Geneva and Faculty of Medicine	Geneva, Switzerland
CHUV	Lausanne, Switzerland