Status:
COMPLETED
Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder
Lead Sponsor:
Novartis
Collaborating Sponsors:
Procter and Gamble
Conditions:
Overactive Bladder (OAB)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study will evaluate safety, efficacy and patient's perception of outcome after treatment with darifenacin (7.5 mg once daily (o.d.) with voluntary increase up to 15 mg o.d.) in patients with OAB ...
Eligibility Criteria
Inclusion
- • Symptoms of OAB for at least six months prior to randomization
- ≥ 8 micturitions on average/24 hours
- ≥ 1 urgency episodes on average/24 hours
- with or without UUIE
- Patients dissatisfied with prior oxybutynin ER or tolterodine ER treatment. Patients must have been on either treatment for at least 1 week and up to 12 months preceding this study. It is required that either oxybutynin ER or tolterodine ER was the most recent OAB medication taken.
- Patients without prior darifenacin treatment
Exclusion
- • A mean daily urinary volume \>3000 mL or a mean volume voided/micturition of \>300 mL as verified in the micturition diary for two consecutive days prior to Baseline
- Males with post-void residual (PVR) urinary volume \>200 mL at Baseline
- Clinically predominant and bothersome stress urinary incontinence, as determined by the investigator
- Urinary retention or clinically significant bladder outlet obstruction as determined by the investigator
- Other protocol-defined inclusion / exclusion criteria may apply
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00366002
Start Date
June 1 2006
End Date
September 1 2007
Last Update
January 15 2008
Active Locations (82)
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1
Investigative Site
Birmingham, Alabama, United States, 35242
2
Investigative Site
Chandler, Arizona, United States, 85224
3
Investigative Site
Mesa, Arizona, United States, 85206
4
Investigative Site
Sierra Vista, Arizona, United States, 85635