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

Novartis

Status and phase: Completed; Phase 3

Conditions: Overactive Bladder Syndrome

Treatments: Drug: Placebo; Drug: Darifenacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00171145

CDAR328A2401

Details and patient eligibility

About

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.

Enrollment: 445 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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445 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Darifenacin

Treatment:

Drug: Darifenacin

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo