SSR240600C Treatment in Women With Overactive Bladder (BILADY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00564226
Recruitment Status : Completed
First Posted : November 27, 2007
Last Update Posted : May 26, 2016
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Overactive Bladder Drug: SSR240600C Drug: tolterodine Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 345 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: SSR240600C Dose Level 1 Drug: SSR240600C
oral administration

Experimental: SSR240600C Dose Level 2 Drug: SSR240600C
oral administration

Experimental: SSR240600C Dose Level 3
dose level 3
Drug: SSR240600C
oral administration

Active Comparator: Tolterodine Drug: tolterodine
oral administration

Placebo Comparator: Placebo Drug: placebo
oral administration

Primary Outcome Measures :
  1. Change from baseline in the number of micturitions per 24 hours [ Time Frame: at week 12 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Safety of SSR240600C [ Time Frame: at week 12 ]
  3. Quality of life [ Time Frame: at week 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   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 participant's potential participation in a clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00564226

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
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Berlin, Germany
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Sanofi-Aventis Administrative Office
Porto Salvo, Portugal
Sponsors and Collaborators
Study Director: ICD CSD Sanofi

Responsible Party: Sanofi Identifier: NCT00564226     History of Changes
Other Study ID Numbers: DRI6271
EudraCT 2007-004126-24
First Posted: November 27, 2007    Key Record Dates
Last Update Posted: May 26, 2016
Last Verified: April 2016

Keywords provided by Sanofi:
urge urinary incontinence

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