A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo

April 13, 2010 updated by: Watson Pharmaceuticals

Multi-Center, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Daily Dosing With Oxybutynin Topical Gel to Treat the Symptoms of Overactive Bladder With a 14-Week Open-Label Safety Extension

A new drug for overactive bladder is compared to placebo to determine if it is safe and effective. The study lasts approximately 12 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

789

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
    • Alabama
      • Birmingham, Alabama, United States
      • Homewood, Alabama, United States
      • Mobile, Alabama, United States
      • Montgomery, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
      • Tucson, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Anaheim, California, United States
      • Buena Park, California, United States
      • Laguna Woods, California, United States
      • Sacramento, California, United States
      • San Diego, California, United States
      • Torrance, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Connecticut
      • Waterbury, Connecticut, United States
    • Florida
      • Aventura, Florida, United States
      • Clearwater, Florida, United States
      • DeLand, Florida, United States
      • Leesburg, Florida, United States
      • Ocala, Florida, United States
      • Plantation, Florida, United States
      • Tallahassee, Florida, United States
      • West Palm Beach, Florida, United States
    • Georgia
      • Alpharetta, Georgia, United States
      • Atlanta, Georgia, United States
    • Illinois
      • Belville, Illinois, United States
      • Chicago, Illinois, United States
      • Melrose Park, Illinois, United States
    • Indiana
      • Evansville, Indiana, United States
      • South Bend, Indiana, United States
    • Louisiana
      • Shreveport, Louisiana, United States
    • Massachusetts
      • Watertown, Massachusetts, United States
    • Michigan
      • Saginaw, Michigan, United States
      • St. Joseph, Michigan, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Albany, New York, United States
      • Garden City, New York, United States
      • New York, New York, United States
      • Williamsville, New York, United States
    • North Carolina
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Lyndhurst, Ohio, United States
    • Oklahoma
      • Bethany, Oklahoma, United States
      • Edmond, Oklahoma, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States
      • Newton, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • West Reading, Pennsylvania, United States
    • Rhode Island
      • Warwick, Rhode Island, United States
    • South Carolina
      • Greer, South Carolina, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Corpus Christi, Texas, United States
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Richmond, Virginia, United States
    • Washington
      • Spokane, Washington, 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:

  • Females and males, 18 years of older with overactive bladder symptoms

Exclusion Criteria:

  • Treatable conditions that may cause urinary incontinence
  • Medical conditions in which it would be unsafe to use an anti-cholinergic agent.
  • The use of concomitant drugs that would confound the efficacy evaluation.
  • The use of concomitant drugs that would be unsafe with an anti-cholinergic agent.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxybutynin topical gel
Drug: Oxybutynin topical gel
1 application daily to skin for 12 weeks
Other Names:
  • Oxybutynin
Placebo Comparator: Placebo topical gel
placebo topical gel
Other: Placebo topical gel
1 application daily to skin for 12 weeks
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline Average Number of Daily Incontinence Episodes
Time Frame: Baseline
Average number of daily incontinence episodes at baseline
Baseline
Change From Baseline in Average Daily Number of Incontinence Episodes
Time Frame: Baseline to Week 12
Change from Baseline to Week 12 in average daily number of incontinence episodes
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline Average Daily Urinary Frequency
Time Frame: Baseline
Number of daily urinary voids
Baseline
Change From Baseline in Average Daily Urinary Frequency
Time Frame: Baseline to 12 weeks
Change from baseline in average daily urinary frequency
Baseline to 12 weeks
Baseline Average Urine Void Volume
Time Frame: Baseline
Baseline average urine void volume
Baseline
Change From Baseline in Average Urine Void Volume
Time Frame: Change from Baseline to Week 12
Change from baseline to Week 12 in average urine void volume
Change from Baseline to Week 12

Collaborators and Investigators

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

Sponsor

Watson Pharmaceuticals

Investigators

  • Study Director: Kim Caramelli, MS, Watson Pharmaceuticals

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

Helpful Links

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

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

July 10, 2006

First Submitted That Met QC Criteria

July 10, 2006

First Posted (Estimate)

July 11, 2006

Study Record Updates

Last Update Posted (Estimate)

May 10, 2010

Last Update Submitted That Met QC Criteria

April 13, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OG05009

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.

Clinical Trials on Overactive Bladder

Clinical Trials on Oxybutynin topical gel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe