Overactive bladder including urge urinary incontinence MedDRA version: 10.0 Level: LLT Classification code 10059617 Term:
Conditions
Interventions
Product Name: SSR240600C
Product Code: SSR240600C
Pharmaceutical Form: Capsule, hard
CAS Number: 299427-93-3
Current Sponsor code: SSR240600C
Other descriptive name: SSR240600 (base)
Concentration uni
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female patients ( 18 to 75 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
Exclusion criteria: Stress incontinence or mixed incontinence where stress incontinence is the predominant component based on prior history; OAB/UUI due to cause other than detrusor overactivity (eg, overflow incontinence, neurogenic bladder, status post surgery or injury which caused OAB or UUI); 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 >30 ml; 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Czech Republic, France, Germany, Netherlands, Portugal
Outcome results
None listed