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

Novartis445 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

445

Conditions

Overactive Bladder Syndrome

Interventions

DarifenacinDRUG

Darifenacin 15 mg tablets once daily

PlaceboDRUG

Placebo tablets once daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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.

Locations (1)

Novartis

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

Change from baseline in warning time at week 12.

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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