Status:
COMPLETED
Using Behavioral Therapy in Combination With Darifenacin for Symptoms of Overactive Bladder
Lead Sponsor:
Novartis
Collaborating Sponsors:
Procter and Gamble
Conditions:
Urinary Incontinence
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is designed to investigate the efficacy and safety of treatment of overactive bladder with darifenacin administered alone or in conjunction with behavioral modification therapies.
Eligibility Criteria
Inclusion
- Symptoms of overactive bladder
- Capable of independent toileting and completing a micturition diary
- Able to comprehend English and follow study procedures and instructions
Exclusion
- Post void residual \> 100ml/sec
- Urine flow rate (Qmax) \<10ml/sec for males only
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
395 Patients enrolled
Trial Details
Trial ID
NCT00127270
Start Date
May 1 2005
End Date
February 1 2006
Last Update
January 24 2008
Active Locations (67)
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1
Alabama Research Center
Birmingham, Alabama, United States, 35209
2
Quality of Life Medical & Research
Tucson, Arizona, United States, 85712
3
UCLA - Urology Sciences Research Foundation
Culver City, California, United States, 90232
4
San Diego Center for Urology Care
La Mesa, California, United States, 91942