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

• Conditions: Overactive bladder including urge urinary incontinence; MedDRA version: 10.0Level: LLTClassification code 10059617Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2007-004126-24-PT
• Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 800

Inclusion Criteria

Female patients ( 18 to 70 years of age, inclusive) diagnosed with overactive bladder (OAB) with symptoms of:
Urge urinary incontinence (UUI) at least 5 UUI episodes per week, AND urgency at least 1 episode per 24 hrs, AND urinary frequency at least 8 micturitions per 24hrs.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 (e.g., overflow incontinence);
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(s);
Post-void residual volume of urinary bladder >10ml;
Current UTI or frequent UTIs (i.e., greater than or equal to 5 UTIs per year);
Concomitant use of medication(s) that are CYP3A substrate(s) with narrow therapeutic range, or potent inhibitor(s) of a CYP450 isoenzyme 3A4, or any treatment with this/these medications within the 4 weeks prior to the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effects of SSR240600C at 25, 50 or 100 mg on symptoms of overactive bladder compared to placebo using tolterodine, as a study calibrator.;Secondary Objective: To evaluate overall safety and tolerability of SSR240600C in the study population compared to placebo.;Primary end point(s): The primary efficacy endpoint is mean change from baseline to week 12 in the number of micturitions per 24 hrs.