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

NCT ID: NCT00224016

Last Updated: 2012-02-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Detrusor Hyperreflexia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oxybutynin Transdermal System

Oxybutynin Transdermal System 1.3 mg/day, 2.6 mg/day, or 3.9 mg/day

Group Type EXPERIMENTAL

Oxybutynin

Intervention Type DRUG

1.3, 2.6, 3.9 mg/day transdermal

Oral oxybutynin

5 to 15 mg/day immediate release or extended release tablets, or syrup

Group Type ACTIVE_COMPARATOR

Oxybutynin

Intervention Type DRUG

5 to 15 mg/day immediate release or extended release tablets, or syrup

Interventions

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Oxybutynin

1.3, 2.6, 3.9 mg/day transdermal

Intervention Type DRUG

Oxybutynin

5 to 15 mg/day immediate release or extended release tablets, or syrup

Intervention Type DRUG

Other Intervention Names

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Oxytrol Ditropan, Ditropan XL, Oxybutynin

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Watson Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gary Hoel, RPh, PhD

Role: STUDY_CHAIR

Watson Laboratories, Inc.

Locations

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Watson Investigational Site

Little Rock, Arkansas, United States

Site Status

Watson Investigational Site

Orange County, California, United States

Site Status

Watson Investigational Site

San Diego, California, United States

Site Status

Watson Investigational Site

Denver, Colorado, United States

Site Status

Watson Investigational Site

Washington D.C., District of Columbia, United States

Site Status

Watson Investigational Site

Detroit, Michigan, United States

Site Status

Watson Investigational Site

Minneapolis, Minnesota, United States

Site Status

Watson Investigational Site

Jackson, Mississippi, United States

Site Status

Watson Investigational Site

Kansas City, Missouri, United States

Site Status

Watson Investigational Site

St Louis, Missouri, United States

Site Status

Watson Investigational Site

Voorhees Township, New Jersey, United States

Site Status

Watson Investigational Site

Albany, New York, United States

Site Status

Watson Investigational Site

Buffalo, New York, United States

Site Status

Watson Investigational Site

Poughkeepsie, New York, United States

Site Status

Watson Investigational Site

Ashville, North Carolina, United States

Site Status

Watson Investigational Site

Durham, North Carolina, United States

Site Status

Watson Investigational Site

Columbus, Ohio, United States

Site Status

Watson Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

Watson Investigational Site

Hershy, Pennsylvania, United States

Site Status

Watson Investigational Site

Dallas, Texas, United States

Site Status

Watson Investigational Site

Houston, Texas, United States

Site Status

Watson Investigational Site

Plano, Texas, United States

Site Status

Watson Investigational Site

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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Cartwright PC, Coplen DE, Kogan BA, Volinn W, Finan E, Hoel G. Efficacy and safety of transdermal and oral oxybutynin in children with neurogenic detrusor overactivity. J Urol. 2009 Oct;182(4):1548-54. doi: 10.1016/j.juro.2009.06.058. Epub 2009 Aug 15.

Reference Type RESULT
PMID: 19683731 (View on PubMed)

Other Identifiers

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O03010

Identifier Type: -

Identifier Source: org_study_id

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