SSR240600C Treatment in Women With Overactive Bladder
Phase 2
Completed
- Conditions
- Overactive Bladder
- Interventions
- Registration Number
- NCT00564226
- Lead Sponsor
- Sanofi
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 345
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 participant's potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SSR240600C Dose Level 2 SSR240600C - SSR240600C Dose Level 1 SSR240600C - Placebo placebo - SSR240600C Dose Level 3 SSR240600C dose level 3 Tolterodine tolterodine -
- Primary Outcome Measures
Name Time Method Change from baseline in the number of micturitions per 24 hours at week 12
- Secondary Outcome Measures
Name Time Method 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 Safety of SSR240600C at week 12 Quality of life at week 12
Trial Locations
- Locations (2)
Sanofi-Aventis Aministrative Office
🇺🇸Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
🇵🇹Porto Salvo, Portugal
Sanofi-Aventis Aministrative Office🇺🇸Bridgewater, New Jersey, United States