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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Darifenacin
Drug: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Procter and Gamble

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CDAR328A2404

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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