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

Detrusor Hyperreflexia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224016
• Other study ID #: O03010
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: February 7, 2012
• Start date: December 2004
• Est. completion date: September 2008

Study information

• Verified date: February 2012
• Source: Watson Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 2008
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Detrusor Hyperreflexia
• Urinary Bladder, Overactive

Intervention

Drug:
• Oxybutynin
1.3, 2.6, 3.9 mg/day transdermal
• Oxybutynin
5 to 15 mg/day immediate release or extended release tablets, or syrup

Locations

Country	Name	City	State
United States	Watson Investigational Site	Albany	New York
United States	Watson Investigational Site	Ashville	North Carolina
United States	Watson Investigational Site	Buffalo	New York
United States	Watson Investigational Site	Columbus	Ohio
United States	Watson Investigational Site	Dallas	Texas
United States	Watson Investigational Site	Denver	Colorado
United States	Watson Investigational Site	Detroit	Michigan
United States	Watson Investigational Site	Durham	North Carolina
United States	Watson Investigational Site	Hershy	Pennsylvania
United States	Watson Investigational Site	Houston	Texas
United States	Watson Investigational Site	Jackson	Mississippi
United States	Watson Investigational Site	Kansas City	Missouri
United States	Watson Investigational Site	Little Rock	Arkansas
United States	Watson Investigational Site	Mineapolis	Minnesota
United States	Watson Investigational Site	Oklahoma City	Oklahoma
United States	Watson Investigational Site	Orange County	California
United States	Watson Investigational Site	Plano	Texas
United States	Watson Investigational Site	Poughkeepsie	New York
United States	Watson Investigational Site	Salt Lake City	Utah
United States	Watson Investigational Site	San Diego	California
United States	Watson Investigational Site	St. Louis	Missouri
United States	Watson Investigational Site	Voorhees	New Jersey
United States	Watson Investigational Site	Washington DC	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Watson Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Er — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Catheterization Urine Volume	Change from baseline in average volume of urine collected by catheterization	14 weeks	No
Secondary	Catheterizations Without Leakage	Percentage of catherizations without leakage	14 weeks	No
Secondary	Urine Volume After First Awakening	Change from baseline in average volume of urine collected after first morning awakening	14 weeks	No