SSR240600C Treatment in Women With Overactive Bladder (BILADY)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00564226
First received: November 26, 2007
Last updated: September 22, 2009
Last verified: September 2009

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 ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Overactive Bladder
  • Drug: SSR240600C
    oral administration
  • Drug: tolterodine
    oral administration
  • Drug: placebo
    oral administration
  • Experimental: 1
    dose level 1
    Intervention: Drug: SSR240600C
  • Experimental: 2
    dose level 2
    Intervention: Drug: SSR240600C
  • Experimental: 3
    dose level 3
    Intervention: Drug: SSR240600C
  • Active Comparator: 4
    Intervention: Drug: tolterodine
  • Placebo Comparator: 5
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
DRI6271, EudraCT 2007-004126-24
Yes
ICD Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: ICD CSD Sanofi
Sanofi
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP