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Completed

NCT Number: NCT00564226

SSR240600C Treatment in Women With Overactive Bladder

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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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis Administrative Office, Laval, Quebec, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SSR240600C

Drug

oral administration

tolterodine

Drug

oral administration

Placebo

Drug

oral administration

Primary outcomes

  1. Change from baseline in the number of micturitions per 24 hours

    Time frame: at week 12

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: BILADY

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 27, 2007
Registry last updated
May 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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