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

January 18, 2008 updated by: Novartis
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

445

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936-108
        • Novartis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Drug: Placebo
Placebo tablets once daily
Experimental: 1
Darifenacin
Drug: Darifenacin
Darifenacin 15 mg tablets once daily
Other Names:
  • Enablex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in warning time at week 12.

Secondary Outcome Measures

Outcome Measure
Quality of life.
Safety and tolerability.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Study Chair: Novartis, East Hanover NJ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

January 23, 2008

Last Update Submitted That Met QC Criteria

January 18, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDAR328A2401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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