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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00224016
First received: September 13, 2005
Last updated: February 7, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention Phase
Detrusor Hyperreflexia
 Drug: Oxybutynin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:
  • Average Catheterization Urine Volume [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    Change from baseline in average volume of urine collected by catheterization


Secondary Outcome Measures:
  • Catheterizations Without Leakage [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    Percentage of catherizations without leakage

  • Urine Volume After First Awakening [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    Change from baseline in average volume of urine collected after first morning awakening


Enrollment: 57
Study Start Date: December 2004
Study Completion Date: September 2008
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   6 Years to 15 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00224016

  Show 23 Study Locations
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
Study Chair: Gary Hoel, RPh, PhD Watson Laboratories, Inc.
  More Information

Publications:

Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00224016     History of Changes
Other Study ID Numbers: O03010
Study First Received: September 13, 2005
Results First Received: November 13, 2009
Last Updated: February 7, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Reflex, Abnormal
Urinary Bladder, Overactive
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Oxybutynin
Mandelic Acids
Parasympatholytics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Renal Agents

ClinicalTrials.gov processed this record on May 16, 2013