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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00224016
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : December 23, 2009
Last Update Posted : February 9, 2012
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Detrusor Hyperreflexia Drug: Oxybutynin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2004
Actual Primary Completion Date : April 2007
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


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 Name: Oxytrol

Active Comparator: Oral oxybutynin
5 to 15 mg/day immediate release or extended release tablets, or syrup
Drug: Oxybutynin
5 to 15 mg/day immediate release or extended release tablets, or syrup
Other Name: Ditropan, Ditropan XL, Oxybutynin




Primary Outcome Measures :
  1. Average Catheterization Urine Volume [ Time Frame: 14 weeks ]
    Change from baseline in average volume of urine collected by catheterization


Secondary Outcome Measures :
  1. Catheterizations Without Leakage [ Time Frame: 14 weeks ]
    Percentage of catherizations without leakage

  2. Urine Volume After First Awakening [ Time Frame: 14 weeks ]
    Change from baseline in average volume of urine collected after first morning awakening



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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00224016


Locations
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United States, Arkansas
Watson Investigational Site
Little Rock, Arkansas, United States
United States, California
Watson Investigational Site
Orange County, California, United States
Watson Investigational Site
San Diego, California, United States
United States, Colorado
Watson Investigational Site
Denver, Colorado, United States
United States, District of Columbia
Watson Investigational Site
Washington DC, District of Columbia, United States
United States, Michigan
Watson Investigational Site
Detroit, Michigan, United States
United States, Minnesota
Watson Investigational Site
Mineapolis, Minnesota, United States
United States, Mississippi
Watson Investigational Site
Jackson, Mississippi, United States
United States, Missouri
Watson Investigational Site
Kansas City, Missouri, United States
Watson Investigational Site
St. Louis, Missouri, United States
United States, New Jersey
Watson Investigational Site
Voorhees, New Jersey, United States
United States, New York
Watson Investigational Site
Albany, New York, United States
Watson Investigational Site
Buffalo, New York, United States
Watson Investigational Site
Poughkeepsie, New York, United States
United States, North Carolina
Watson Investigational Site
Ashville, North Carolina, United States
Watson Investigational Site
Durham, North Carolina, United States
United States, Ohio
Watson Investigational Site
Columbus, Ohio, United States
United States, Oklahoma
Watson Investigational Site
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Watson Investigational Site
Hershy, Pennsylvania, United States
United States, Texas
Watson Investigational Site
Dallas, Texas, United States
Watson Investigational Site
Houston, Texas, United States
Watson Investigational Site
Plano, Texas, United States
United States, Utah
Watson Investigational Site
Salt Lake City, Utah, United States
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
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Study Chair: Gary Hoel, RPh, PhD Watson Laboratories, Inc.

Publications of Results:
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Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00224016    
Other Study ID Numbers: O03010
First Posted: September 22, 2005    Key Record Dates
Results First Posted: December 23, 2009
Last Update Posted: February 9, 2012
Last Verified: February 2012
Additional relevant MeSH terms:
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Reflex, Abnormal
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mandelic Acids
Oxybutynin
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents