| November 26, 2007 |
| September 22, 2009 |
| November 2007 |
| February 2009 (final data collection date for primary outcome measure) |
| Change from baseline in the number of micturitions per 24 hours [ Time Frame: at week 12 ] [ Designated as safety issue: No ] |
| Change from baseline in the number of micturitions per 24 hours [ Time Frame: at week 12 ] |
| Complete list of historical versions of study NCT00564226 on ClinicalTrials.gov Archive Site |
- 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 [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
- Safety of SSR240600 [ Time Frame: at week 12 ] [ Designated as safety issue: Yes ]
- Quality of life [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
|
- 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 [ Time Frame: at week 12 ]
- Safety of SSR240600 [ Time Frame: at week 12 ]
- Quality of life [ Time Frame: at week 12 ]
|
| |
| SSR240600C Treatment in Women With Overactive Bladder |
| 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 |
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. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Overactive Bladder |
- Drug: SSR240600C
- Drug: tolterodine
- Drug: placebo
|
- Experimental: dose level 1
- Experimental: dose level 2
- Experimental: dose level 3
|
| |
| |
| Completed |
| 345 |
| February 2009 |
| February 2009 (final data collection date for primary outcome measure) |
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 patient's potential participation in a clinical trial. |
| Female |
| 18 Years to 70 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Canada, Czech Republic, France, Germany, Netherlands, Portugal |
| |
| NCT00564226 |
| ICD Study Director, sanofi-aventis |
| DRI6271, EudraCT 2007-004126-24 |
| Sanofi-Aventis |
|
| Study Director: |
ICD CSD |
Sanofi-Aventis |
|
|
| Sanofi-Aventis |
| September 2009 |
