Transdermal (TDS) Oxybutynin (Oxytrol(r)) in Overactive Bladder (MATRIX)

November 29, 2011 updated by: Watson Pharmaceuticals

Multicenter Assessment of Transdermal Therapy in Overactive Bladder With Oxybutynin TDS (MATRIX)

This study evaluates changes in health related quality of life outcomes in patients using Oxytrol(r)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2878

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

  • United States
    • Alabama
      • Mobile, Alabama, United States
    • Arizona
      • Tucson, Arizona, United States
    • California
      • Torrance, California, United States
    • Connecticut
      • Rocky Hill, Connecticut, United States
    • Georgia
      • Valdosta, Georgia, United States
    • Louisiana
      • Gretna, Louisiana, United States
    • Michigan
      • Bloomfield Hills, Michigan, United States
    • New York
      • Poughkeepsie, New York, United States
    • North Carolina
      • Winston-Salem, North Carolina, United States
    • Texas
      • Tomball, Texas, United States

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients with one or more symptom of overactive bladder, including urge urinary incontinence, urgency and/or frequency

Exclusion Criteria:

  • Patients for whom Oxytrol(r) is contraindicated.
  • Patients treated with Oxytrol(r) prior to participation in this study.
  • Patients residing in long-term care facilities or nursing homes.

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: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in health-related quality of life

Secondary Outcome Measures

Outcome Measure
depression
Change in other outcomes such as:
work productivity
participant satisfaction
effect of enhanced patient education on any of the above outcomes

Collaborators and Investigators

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

Sponsor

Watson Pharmaceuticals

Investigators

  • Study Director: Naomi V. Dahl, PharmD, Watson Laboratories, Inc.

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

May 1, 2004

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

November 30, 2011

Last Update Submitted That Met QC Criteria

November 29, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OXY0402
  • MATRIx

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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