Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition - Full Text View

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:

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 ]
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 (Child)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

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
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 Lower Urinary Tract Symptoms Urological Manifestations 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

ClinicalTrials.gov processed this record on September 23, 2016