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SSR240600C Treatment in Women With Overactive Bladder (BILADY)

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SSR240600C
tolterodine
placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring urge urinary incontinence

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Aministrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

SSR240600C Dose Level 1

SSR240600C Dose Level 2

SSR240600C Dose Level 3

Tolterodine

Placebo

Arm Description

dose level 3

Outcomes

Primary Outcome Measures

Change from baseline in the number of micturitions per 24 hours

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
Safety of SSR240600C
Quality of life

Full Information

First Posted
November 26, 2007
Last Updated
April 27, 2016
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00564226
Brief Title
SSR240600C Treatment in Women With Overactive Bladder
Acronym
BILADY
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 Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
urge urinary incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
345 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SSR240600C Dose Level 1
Arm Type
Experimental
Arm Title
SSR240600C Dose Level 2
Arm Type
Experimental
Arm Title
SSR240600C Dose Level 3
Arm Type
Experimental
Arm Description
dose level 3
Arm Title
Tolterodine
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SSR240600C
Intervention Description
oral administration
Intervention Type
Drug
Intervention Name(s)
tolterodine
Intervention Description
oral administration
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral administration
Primary Outcome Measure Information:
Title
Change from baseline in the number of micturitions per 24 hours
Time Frame
at week 12
Secondary Outcome Measure Information:
Title
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
Title
Safety of SSR240600C
Time Frame
at week 12
Title
Quality of life
Time Frame
at week 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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 participant's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Aministrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis Administrative Office
City
Laval
State/Province
Quebec
Country
Canada
Facility Name
Sanofi-Aventis Administrative Office
City
Praha
Country
Czech Republic
Facility Name
Sanofi-Aventis Administrative Office
City
Paris
Country
France
Facility Name
Sanofi-Aventis Administrative Office
City
Berlin
Country
Germany
Facility Name
Sanofi-Aventis Administrative Office
City
Gouda
Country
Netherlands
Facility Name
Sanofi-Aventis Administrative Office
City
Porto Salvo
Country
Portugal

12. IPD Sharing Statement

Learn more about this trial

SSR240600C Treatment in Women With Overactive Bladder

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