MILADY: A Randomized, Placebo-controlled Safety and Efficacy Trial of SSR240600C in Treatment of Overactive Bladder or Urge Urinary Incontinence.
- Conditions
- Overactive Bladder
- Interventions
- Registration Number
- NCT00174798
- Lead Sponsor
- Sanofi
- Brief Summary
To evaluate the safety and efficacy of SSR240600C versus placebo on clinical and cystometric parameters in patients with OAB and UUI.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 118
- Females between 18 and 75 years, inclusive Clinical diagnosis of OAB/UUI (symptoms of frequent micturition, urinary urgency)
- Bladder capacity </= 300 mL by cystometry
- History of interstitial cystitis, bladder outlet obstruction or other significant genitourinary disorder
- Current urinary tract infection
- Neurological bladder dysfunction
- Treatment with drugs that may interfere with CYP3A4 metabolic function
- History of stress urinary incontinence
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SSR240600C SSR240600C - Placebo Placebo - Tolterodine Tolterodine -
- Primary Outcome Measures
Name Time Method Change in bladder capacity as determined by cystometric parameters from baseline to end of treatment.
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (22)
Hope Research LLC
🇺🇸Phoenix, Arizona, United States
Research Tuscon
🇺🇸Tuscon, Arizona, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Genitourinary Surgical Consultants
🇺🇸Denver, Colorado, United States
Connecticut Clinical Research Center, Urology Specialists
🇺🇸Waterbury, Connecticut, United States
Miami Research Associates
🇺🇸Miami, Florida, United States
Southeastern Research Group
🇺🇸Tallahassee, Florida, United States
Atlanta Women's Research Institute
🇺🇸Alpharetta, Georgia, United States
Mount Vernon Clinical Research
🇺🇸Atlanta, Georgia, United States
Soapstone Center for Education & Clinical Research
🇺🇸Decatur, Georgia, United States
Scroll for more (12 remaining)Hope Research LLC🇺🇸Phoenix, Arizona, United States