MILADY: A Randomized, Placebo-controlled Safety and Efficacy Trial of SSR240600C in Treatment of Overactive Bladder or Urge Urinary Incontinence.
To evaluate the safety and efficacy of SSR240600C versus placebo on clinical and cystometric parameters in patients with OAB and UUI.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-blind, Placebo and Active-controlled Efficacy and Safety Study of SSR240600C in Patients With Overactive Bladder (OAB) or Urge Urinary Incontinence (UUI)|
- Change in bladder capacity as determined by cystometric parameters from baseline to end of treatment.
- Change from baseline to end of treatment in:maximum detrusor pressure,volume ar first desire to void,volume at first unstable contraction,micturition frequence,urgency episodes,nocturia episodes,incontinence episodes,HRQOL and overall improvement
|Study Start Date:||May 2005|
|Study Completion Date:||May 2006|
|Primary Completion Date:||May 2006 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo||
|Active Comparator: Tolterodine||
Prospective, randomized, parallel group, double-dummy, placebo and active-controlled (Detrol LA - tolterodine) trial wherein patients with OAB or UUI will receive single daily does of either SSR240600C 500 mg, tolterodine 4 mg or placebo for four weeks. Baseline and end of study cystometry will be performed; daily symptom diaries will be completed during the trial and health-related quality of life will be measured before and after study drug treatment. Patients will be followed-up one week after completion of the trial. Study participation will include 5 visits over a period of six weeks.
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|Study Director:||Clinical Sciences & Operations||Sanofi|