A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.
|ClinicalTrials.gov Identifier: NCT00171145|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : January 23, 2008
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder Syndrome||Drug: Darifenacin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||445 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.|
|Study Start Date :||April 2004|
|Actual Study Completion Date :||December 2004|
Darifenacin 15 mg tablets once daily
Other Name: Enablex
Placebo Comparator: 2
Placebo tablets once daily
- Change from baseline in warning time at week 12.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171145
|United States, New Jersey|
|East Hanover, New Jersey, United States, 07936-108|
|Study Chair:||Novartis||East Hanover NJ|