A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.

Completed · Phase 3 · Has a placebo group

Conditions studied: Overactive Bladder Syndrome

In brief

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.

Key facts

Study ID

NCT00171145

Run by

Novartis

People needed

445

Starts

2004-04-01

Expected to finish

2004-12-01

Last updated by the study team

2008-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Novartis — East Hanover, New Jersey, United States

Full record on ClinicalTrials.gov

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