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NCT00171145 Clinical Trial

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

Overactive Bladder Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00171145
Other study ID # CDAR328A2401
Secondary ID
Status Completed
Phase Phase 3
First received September 12, 2005
Last updated January 18, 2008
Start date April 2004
Est. completion date December 2004

Study information
Verified date January 2008
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 445
Est. completion date December 2004
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Darifenacin
Darifenacin 15 mg tablets once daily
• Placebo
Placebo tablets once daily

Locations
Country Name City State
United States Novartis East Hanover New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in warning time at week 12.
Secondary Change in warning time at weeks 2 & 6.
Secondary Change in frequency of urge incontinence episodes.
Secondary Change in frequency of micturitions.
Secondary Change in mean volume per void.
Secondary Change in frequency of urgency.
Secondary Safety and tolerability.
Secondary Quality of life.
See also
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