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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 23 Study Locations

Sponsors and Collaborators

Watson Pharmaceuticals

Investigators

Study Chair:	Gary Hoel, RPh, PhD	Watson Laboratories, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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. Erratum in: J Urol. 2009 Dec;182(6):2985. Dosage error in article text.

Responsible Party:	Watson Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00224016 History of Changes
Other Study ID Numbers:	O03010
First Posted:	September 22, 2005
Results First Posted:	December 23, 2009
Last Update Posted:	February 9, 2012
Last Verified:	February 2012

Additional relevant MeSH terms:

Reflex, Abnormal; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Oxybutynin; Mandelic Acids; 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