SSR240600C Treatment in Women With Overactive Bladder (BILADY)

Sanofi

Status and phase: Completed; Phase 2

Conditions: Overactive Bladder

Treatments: Drug: placebo; Drug: tolterodine; Drug: SSR240600C

Study type: Interventional

Funder types: Industry

Identifiers

NCT00564226

DRI6271

EudraCT 2007-004126-24

Details and patient eligibility

About

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.

Enrollment: 345 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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345 participants in 5 patient groups, including a placebo group

SSR240600C Dose Level 1

Experimental group

Treatment:

Drug: SSR240600C

SSR240600C Dose Level 2

Experimental group

Treatment:

Drug: SSR240600C

SSR240600C Dose Level 3

Experimental group

Description:

dose level 3

Treatment:

Drug: SSR240600C

Tolterodine

Active Comparator group

Treatment:

Drug: tolterodine

Placebo

Placebo Comparator group

Treatment:

Drug: placebo