Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004145

Trial Description

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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

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Trial Acronym

BILADY

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

[---]*

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Organizational Data

  •   DRKS00004145
  •   2012/11/22
  •   2007/11/26
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   2007-004126-24 
  •   NCT00564226  (ClinicalTrials.gov)
  •   DRI6271  (Sanofi-Aventis)
  •   EudraCT 2007-004126-24 
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Health Condition or Problem studied

  •   Overactive Bladder
  •   N32.8 -  Other specified disorders of bladder
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Interventions/Observational Groups

  •   Drug: SSR240600C
  •   Drug: tolterodine
  •   Drug: placebo
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo, Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II
  •   [---]*
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Primary Outcome

- Change from baseline in the number of micturitions per 24 hours; time frame: at week 12

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Secondary Outcome

- 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

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Countries of Recruitment

  •   United States
  •   Canada
  •   Czech Republic
  •   France
  •   Germany
  •   Netherlands
  •   Portugal
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2007/11/30
  •   345
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Female
  •   18   Years
  •   70   Years
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Additional Inclusion Criteria

- Diagnosis of overactive bladder

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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.

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Addresses

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    • Sanofi
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    •   [---]*
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    • Sanofi
    • ICD CSD 
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Sanofi
    • ICD CSD 
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2009/02/01
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Trial Publications, Results and other Documents

  • [---]*
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.