A Study Evaluating the Safety, Effectiveness, and Pharmacokinetics of Transdermal Oxybutynin in Treating Overactive Bladder Associated With a Neurological Condition - Full Text View

Sponsor:	Watson Pharmaceuticals
Information provided by:	Watson Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00224016

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Open-Label, Active-Controlled, Dose-Titration Study Evaluating the Safety, Efficacy and Pharmacokinetics of Oxybutynin Transdermal Systems in the Treatment of Detrusor Overactivity Associated With a Neurological Condition in Pediatric Patients, Followed by a 12-Week Open-Label Safety Extension Study

Resource links provided by NLM:

MedlinePlus related topics: Urine and Urination

Drug Information available for: Oxybutynin chloride Oxybutynin

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 ]

Secondary Outcome Measures:

Catheterizations Without Leakage [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Urine Volume After First Awakening [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

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
Oxybutynin Transdermal System: Experimental 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
Oral oxybutynin: Active Comparator 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

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 Pharmaceuticals

More Information

Publications:

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. Epub 2009 Aug 15. Erratum in: J Urol. 2009 Dec;182(6):2985. Dosage error in article text.

Responsible Party:	Watson ( Gary Hoel RPh, PhD; Executive Director, )
Study ID Numbers:	O03010
Study First Received:	September 13, 2005
Results First Received:	November 13, 2009
Last Updated:	November 13, 2009
ClinicalTrials.gov Identifier:	NCT00224016 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Oxybutynin
Urinary Bladder, Overactive
Parasympatholytics
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Nervous System Diseases
Urinary Bladder Diseases
Physiological Effects of Drugs
Cholinergic Agents

Pharmacologic Actions
Muscarinic Antagonists
Signs and Symptoms
Urological Manifestations
Urologic Diseases
Autonomic Agents
Neurologic Manifestations
Reflex, Abnormal
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010