A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.

Phase 3

Completed

• Conditions: Overactive Bladder Syndrome
• Interventions: Drug: Placebo; Drug: Darifenacin

• Registration Number: NCT00171145
• Lead Sponsor: Novartis

Brief Summary

This study will assess the efficacy of a 12-week treatment with darifenacin in increasing warning time, the time from first sensation of urgency to voiding, in patients with OAB.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study Completion: 2004-12
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-18
• Last Update Posted: 2008-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 445

Inclusion Criteria

• Three symptoms of OAB (urge incontinence, frequency and urgency) for at least six months prior to Visit 2.
• Patients capable of independent toileting and able of independently completing the patient diary.

Exclusion Criteria

• Patients in whom the use of anticholinergic drugs was contraindicated
• Evidence of severe liver disease
• Patients with other clinically significant urinary or gynecological conditions

Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo
1	Darifenacin	Darifenacin

Primary Outcome Measures

Name	Time	Method
Change from baseline in warning time at week 12.

Secondary Outcome Measures

Name	Time	Method
Change in warning time at weeks 2 & 6.
Change in frequency of urge incontinence episodes.
Change in frequency of micturitions.
Change in mean volume per void.
Change in frequency of urgency.
Safety and tolerability.
Quality of life.

Trial Locations

Locations (1)

Novartis; 🇺🇸 East Hanover, New Jersey, United States