Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition

February 7, 2012 updated by: Watson Pharmaceuticals

A Multi-Center, Open-Label (OL), Active-Controlled, Dose-Titration Study Evaluating the Safety, Efficacy and PK of Oxybutynin Transdermal Systems in the Treatment of Detrusor Overactivity in Pediatric Patients

This study will evaluate the safety and effectiveness of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in children who have a neurological condition (e.g. spina bifida) that contributes to their overactive bladder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will use a multicenter, randomized, open-label, active-controlled, dose-titration, parallel group design, in approximately pediatric patients with detrusor overactivity associated with a neurological condition.

Study Type

Interventional

Enrollment (Actual)

57

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
    • Arkansas
      • Little Rock, Arkansas, United States
        • Watson Investigational Site
    • California
      • Orange County, California, United States
        • Watson Investigational Site
      • San Diego, California, United States
        • Watson Investigational Site
    • Colorado
      • Denver, Colorado, United States
        • Watson Investigational Site
    • District of Columbia
      • Washington DC, District of Columbia, United States
        • Watson Investigational Site
    • Michigan
      • Detroit, Michigan, United States
        • Watson Investigational Site
    • Minnesota
      • Mineapolis, Minnesota, United States
        • Watson Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States
        • Watson Investigational Site
    • Missouri
      • Kansas City, Missouri, United States
        • Watson Investigational Site
      • St. Louis, Missouri, United States
        • Watson Investigational Site
    • New Jersey
      • Voorhees, New Jersey, United States
        • Watson Investigational Site
    • New York
      • Albany, New York, United States
        • Watson Investigational Site
      • Buffalo, New York, United States
        • Watson Investigational Site
      • Poughkeepsie, New York, United States
        • Watson Investigational Site
    • North Carolina
      • Ashville, North Carolina, United States
        • Watson Investigational Site
      • Durham, North Carolina, United States
        • Watson Investigational Site
    • Ohio
      • Columbus, Ohio, United States
        • Watson Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Watson Investigational Site
    • Pennsylvania
      • Hershy, Pennsylvania, United States
        • Watson Investigational Site
    • Texas
      • Dallas, Texas, United States
        • Watson Investigational Site
      • Houston, Texas, United States
        • Watson Investigational Site
      • Plano, Texas, United States
        • Watson Investigational Site
    • Utah
      • Salt Lake City, Utah, United States
        • Watson Investigational 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

6 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pediatric patient with a diagnosis of detrusor overactivity associated with a neurological condition;
  • Use clean intermittent catheterization
  • On stable dose of oral oxybutynin before participation

Exclusion Criteria:

  • Have one or more treatable conditions, other than neurogenic bladder dysfunction, that may cause urinary incontinence or urgency
  • Have any medical condition that precludes their participation in the study or may confound the outcome of the study

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxybutynin Transdermal System
Oxybutynin Transdermal System 1.3 mg/day, 2.6 mg/day, or 3.9 mg/day
Drug: Oxybutynin
1.3, 2.6, 3.9 mg/day transdermal
Other Names:
  • Oxytrol
Drug: Oxybutynin
5 to 15 mg/day immediate release or extended release tablets, or syrup
Other Names:
  • Ditropan, Ditropan XL, Oxybutynin
Active Comparator: Oral oxybutynin
5 to 15 mg/day immediate release or extended release tablets, or syrup
Drug: Oxybutynin
1.3, 2.6, 3.9 mg/day transdermal
Other Names:
  • Oxytrol
Drug: Oxybutynin
5 to 15 mg/day immediate release or extended release tablets, or syrup
Other Names:
  • Ditropan, Ditropan XL, Oxybutynin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Catheterization Urine Volume
Time Frame: 14 weeks
Change from baseline in average volume of urine collected by catheterization
14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Catheterizations Without Leakage
Time Frame: 14 weeks
Percentage of catherizations without leakage
14 weeks
Urine Volume After First Awakening
Time Frame: 14 weeks
Change from baseline in average volume of urine collected after first morning awakening
14 weeks

Collaborators and Investigators

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

Sponsor

Watson Pharmaceuticals

Investigators

  • Study Chair: Gary Hoel, RPh, PhD, 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

December 1, 2004

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

February 9, 2012

Last Update Submitted That Met QC Criteria

February 7, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • O03010

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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