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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Overactive Bladder
 Drug: SSR240600C
Drug: tolterodine
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline in the number of micturitions per 24 hours [ Time Frame: at week 12 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ 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 ]

Enrollment: 345
Study Start Date: November 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
dose level 1
 Drug: SSR240600C
oral administration
Experimental: 2
dose level 2
 Drug: SSR240600C
oral administration
Experimental: 3
dose level 3
 Drug: SSR240600C
oral administration
Active Comparator: 4 Drug: tolterodine
oral administration
Placebo Comparator: 5 Drug: placebo
oral administration

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564226

Locations
United States, New Jersey
Sanofi-Aventis Aministrative Office
Bridgewater, New Jersey, United States, 08807
Canada, Quebec
Sanofi-Aventis Administrative Office
Laval, Quebec, Canada
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Portugal
Sanofi-Aventis Administrative Office
Porto Salvo, Portugal
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00564226     History of Changes
Other Study ID Numbers: DRI6271, EudraCT 2007-004126-24
Study First Received: November 26, 2007
Last Updated: September 22, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by Sanofi:
urge urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Urge
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases
 Tolterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013