Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder

January 14, 2008 updated by: Novartis

A 12-Week, Open-Label, Non-Randomized, Multicenter Study to Evaluate the Patient's Perception of Outcome After Treatment With Darifenacin in Overactive Bladder (OAB) Patients Dissatisfied With Prior Anticholinergic Therapy

This study will evaluate safety, efficacy and patient's perception of outcome after treatment with darifenacin (7.5 mg once daily (o.d.) with voluntary increase up to 15 mg o.d.) in patients with OAB who are dissatisfied with prior oxybutynin extended release (ER) or tolterodine extended release (ER) therapy.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Phase 4

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

    • Alabama
      • Birmingham, Alabama, United States, 35242
        • Investigative Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Investigative Site
      • Mesa, Arizona, United States, 85206
        • Investigative Site
      • Sierra Vista, Arizona, United States, 85635
        • Investigative Site
      • Tempe, Arizona, United States, 85282
        • Investigative Site
    • California
      • Atherton, California, United States, 94027
        • Investigative Site
      • Los Angeles, California, United States, 90048
        • Investigative Site
      • Newport Beach, California, United States, 92660
        • Investigative Site
      • San Diego, California, United States, 92108
        • Investigative Site
      • Temecula, California, United States, 92591
        • Investigative Site
      • Torrance, California, United States, 90505
        • Investigative Site
      • Upland, California, United States, 91786
        • Investigative Site
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Investigative Site
      • Littleton, Colorado, United States, 80122
        • Investigative Site
      • Wheat Ridge, Colorado, United States, 80033
        • Investigative Site
    • Florida
      • Hollywood, Florida, United States, 33021
        • Investigative Site
      • New Smyrna Beach, Florida, United States, 32168
        • Investigative Site
      • Ocala, Florida, United States, 34474
        • Investigative Site
      • Orlando, Florida, United States, 32803
        • Investigative Site
      • Sarasota, Florida, United States, 34237
        • Investigative Site
      • Tampa, Florida, United States, 33607
        • Investigative Site
      • West Palm Beach, Florida, United States, 33409
        • Investigative Site
      • Weston, Florida, United States, 33331
        • Investigative Site
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Investigative Site
      • Atlanta, Georgia, United States, 30342
        • Investigative Site
      • Marietta, Georgia, United States, 30060
        • Investigative Site
      • Roswell, Georgia, United States, 30076
        • Investigative Site
      • Snellville, Georgia, United States, 30078
        • Investigative Site
    • Illinois
      • Melrose Park, Illinois, United States, 60160
        • Investigative Site
      • O'Fallon, Illinois, United States, 62269
        • Investigative Site
      • Peoria, Illinois, United States, 61615
        • Investigative Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Investigative Site
      • Greenwood, Indiana, United States, 46143
        • Investigative Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Investigative Site
    • Massachusetts
      • Milford, Massachusetts, United States, 01757
        • Investigative Site
      • Watertown, Massachusetts, United States, 02472
        • Investigative Site
    • Michigan
      • Flint, Michigan, United States, 48507
        • Investigative Site
      • Saint Joseph, Michigan, United States, 49085
        • Investigative Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Investigative Site
      • Kansas City, Missouri, United States, 64114
        • Investigative Site
      • St. Louis, Missouri, United States, 63136
        • Investigative Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Investigative Site
      • Omaha, Nebraska, United States, 68114
        • Investigative Site
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Investigative Site
      • West Orange, New Jersey, United States, 07052
        • Investigative Site
    • New York
      • Albany, New York, United States, 12206
        • Investigative Site
      • Garden City, New York, United States, 11530
        • Investigative Site
      • Latham, New York, United States, 12110
        • Investigative Site
      • Mineola, New York, United States, 11501
        • Investigative Site
      • New Hartford, New York, United States, 13413
        • Investigative Site
      • Poughkeepsie, New York, United States, 12601
        • Investigative Site
      • Troy, New York, United States, 12180
        • Investigative Site
      • Williamsville, New York, United States, 14221
        • Investigative Site
    • North Carolina
      • Burlington, North Carolina, United States, 27215
        • Investigative Site
      • Charlotte, North Carolina, United States, 28209
        • Investigative Site
      • Concord, North Carolina, United States, 28205
        • Investigative Site
      • Hickory, North Carolina, United States, 28601
        • Investigative Site
      • High Point, North Carolina, United States, 27262
        • Investigative Site
      • Salisbury, North Carolina, United States, 28144
        • Investigative Site
      • Winston Salem, North Carolina, United States, 27103
        • Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • Investigative Site
    • Oklahoma
      • Bethany, Oklahoma, United States, 73008
        • Investigative Site
      • Edmond, Oklahoma, United States, 73034
        • Investigative Site
    • Oregon
      • Portland, Oregon, United States, 97205
        • Investigative Site
      • Springfield, Oregon, United States, 97477
        • Investigative Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Investigative Site
    • Texas
      • Amarillo, Texas, United States, 79106
        • Investigative Site
      • Corsicana, Texas, United States, 75110
        • Investigative Site
      • Dallas, Texas, United States, 75231
        • Investigative Site
      • Fort Worth, Texas, United States, 76104
        • Investigative Site
      • Houston, Texas, United States, 77005
        • Investigative Site
      • Lake Jackson, Texas, United States, 77566
        • Investigative Site
    • Utah
      • Bountiful, Utah, United States, 84010
        • Investigative Site
      • Salt Lake City, Utah, United States, 84124
        • Investigative Site
      • Sandy, Utah, United States, 84070
        • Investigative Site
    • Virginia
      • Richmond, Virginia, United States, 23294
        • Investigative Site
    • Washington
      • Everett, Washington, United States, 98208
        • Investigative Site
      • Lakewood, Washington, United States, 98499
        • Investigative Site
      • Mountlake Terrace, Washington, United States, 98233
        • Investigative Site
      • Seattle, Washington, United States, 98101
        • Investigative Site
      • Vancouver, Washington, United States, 98664
        • Investigative Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Investigative Site

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:

  • • Symptoms of OAB for at least six months prior to randomization

    • ≥ 8 micturitions on average/24 hours
    • ≥ 1 urgency episodes on average/24 hours
    • with or without UUIE

      • Patients dissatisfied with prior oxybutynin ER or tolterodine ER treatment. Patients must have been on either treatment for at least 1 week and up to 12 months preceding this study. It is required that either oxybutynin ER or tolterodine ER was the most recent OAB medication taken.
      • Patients without prior darifenacin treatment

Exclusion Criteria:

  • • A mean daily urinary volume >3000 mL or a mean volume voided/micturition of >300 mL as verified in the micturition diary for two consecutive days prior to Baseline

    • Males with post-void residual (PVR) urinary volume >200 mL at Baseline
    • Clinically predominant and bothersome stress urinary incontinence, as determined by the investigator
    • Urinary retention or clinically significant bladder outlet obstruction as determined by the investigator

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Darifenacin
Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily
Other Names:
  • Enablex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in the patient's perception of outcome at Week 13 using the Patient Perception Bladder Condition questionnaire (PPBC).

Secondary Outcome Measures

Outcome Measure
Patient's perception of outcome using the PPBC questionnaire at Week 7.
Patient's satisfaction by using the Patient Satisfaction Treatment Benefits questionnaire (PSTB, Part I) at Week 13.
Assessment of efficacy of darifenacin with respect to change from baseline in:
Number of micturitions per day at Weeks 7 and 13
Number of urgency episodes per day at Weeks 7 and 13
Number of urge urinary incontinence episodes (UUIE) per week at Weeks 7 and 13
Assessment of safety and tolerability

Collaborators and Investigators

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

Sponsor

Collaborators

Investigators

  • Study Chair: Novartis Pharmaceutical Corporation, NPC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

June 1, 2006

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

August 17, 2006

First Submitted That Met QC Criteria

August 17, 2006

First Posted (Estimate)

August 18, 2006

Study Record Updates

Last Update Posted (Estimate)

January 15, 2008

Last Update Submitted That Met QC Criteria

January 14, 2008

Last Verified

January 1, 2008

More Information

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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