SSR240600C Treatment in Women With Overactive Bladder

Overactive Bladder Clinical Trial

— BILADY  

Official title:

A Placebo Controlled Randomized, 12-week, Dose-ranging, Double-blind Study Versus Placebo Using Tolterodine as a Study Calibrator, to Evaluate Efficacy and Safety of SSR240600C in Women With Overactive Bladder Including Urge Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00564226
• Other study ID #: DRI6271
• Secondary ID: EudraCT 2007-004
• Status: Completed
• Phase: Phase 2
• First received: November 26, 2007
• Last updated: September 22, 2009
• Start date: November 2007
• Est. completion date: February 2009

Study information

• Verified date: September 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaNetherlands: Medicines Evaluation Board (MEB)
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the efficacy of SSR240600C in women with overactive bladder compared to placebo using tolterodine as a study calibrator.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosis of overactive bladder

Exclusion Criteria:

• Stress incontinence or mixed incontinence where stress incontinence is the predominant component based on prior history

• Urinary incontinence due to cause other than detrusor overactivity (eg, overflow incontinence)

• Current Urinary Tract Infection (UTI) or frequent UTIs

• Urinary retention or other evidence of poor detrusor function

• Pain during voiding or bladder pain without voiding

• History of radiation cystitis or history of pelvic irradiation

• History of interstitial cystitis or bladder related pain syndrome

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Incontinence
• Urinary Incontinence, Urge

Intervention

Drug:
• SSR240600C
oral administration
• tolterodine
oral administration
• placebo
oral administration

Locations

Country	Name	City	State
Canada	Sanofi-Aventis Administrative Office	Laval	Quebec
Czech Republic	Sanofi-Aventis Administrative Office	Praha
France	Sanofi-Aventis Administrative Office	Paris
Germany	Sanofi-Aventis Administrative Office	Berlin
Netherlands	Sanofi-Aventis Administrative Office	Gouda
Portugal	Sanofi-Aventis Administrative Office	Porto Salvo
United States	Sanofi-Aventis Aministrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  France,  Germany,  Netherlands,  Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the number of micturitions per 24 hours		at week 12	No
Secondary	Changes from baseline in number of urge urinary incontinence episodes, in number of urgency episodes, in number of nocturia episodes, in volume of urine per void		at week 12	No
Secondary	Safety of SSR240600		at week 12	Yes
Secondary	Quality of life		at week 12	No