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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00564226 |
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Date of registration:
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26/11/2007 |
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Primary sponsor: |
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Public title:
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SSR240600C Treatment in Women With Overactive Bladder
BILADY |
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Scientific title:
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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 |
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Date of first enrolment:
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November 2007 |
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Target sample size:
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345 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00564226 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Canada
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Czech Republic
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France
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Germany
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Netherlands
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Portugal
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United States
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Contacts
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Name:
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ICD CSD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi-Aventis |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Overactive Bladder
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Intervention(s)
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Drug: placebo
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Drug: SSR240600C
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Drug: tolterodine
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Primary Outcome(s)
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Change from baseline in the number of micturitions per 24 hours
[Time Frame: at week 12]
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Secondary Outcome(s)
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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]
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Quality of life
[Time Frame: at week 12]
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Safety of SSR240600
[Time Frame: at week 12]
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Secondary ID(s)
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DRI6271
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EudraCT 2007-004126-24
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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