Status:
COMPLETED
A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.
Lead Sponsor:
Novartis
Conditions:
Overactive Bladder Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
445 Patients enrolled
Trial Details
Trial ID
NCT00171145
Start Date
April 1 2004
End Date
December 1 2004
Last Update
January 23 2008
Active Locations (1)
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1
Novartis
East Hanover, New Jersey, United States, 07936-108