A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.
This study has been completed.
Information provided by:
First received: September 12, 2005
Last updated: January 18, 2008
Last verified: January 2008
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Change from baseline in warning time at week 12.
Secondary Outcome Measures:
- 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.
|Study Start Date:||April 2004|
|Study Completion Date:||December 2004|
Darifenacin 15 mg tablets once daily
Other Name: Enablex
Placebo Comparator: 2
Placebo tablets once daily
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