Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: February 2009

Intervention(s) in this Clinical Trial

• Drug: SSR240600C
  • oral administration
• Drug: tolterodine
  • oral administration
• Drug: placebo
  • oral administration

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • dose level 1
• Experimental: 2
  • dose level 2
• Experimental: 3
  • dose level 3
• Active Comparator: 4
• Placebo Comparator: 5

Primary Measures

• Change from baseline in the number of micturitions per 24 hours
  • Time Frame: at week 12
    Safety Issue?: No

Secondary Measures

• 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 Issue?: No
• Safety of SSR240600
  • Time Frame: at week 12
    Safety Issue?: Yes
• Quality of life
  • Time Frame: at week 12
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

ICD CSD Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on January 09, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00564226

Study ID Number: DRI6271

ClinicalTrials.gov Identifier: NCT00564226

Health Authority: United States: Food and Drug Administration