Clinical trial NCT00224016: Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Detrusor Hyperreflexia
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 57
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Average Catheterization Urine Volume
timeFrame: 14 weeks
Secondary outcomes:
measure: Catheterizations Without Leakage
timeFrame: 14 weeks
measure: Urine Volume After First Awakening
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Watson Investigational Site
state: Arkansas
city: Orange County
country: United States
facility: Watson Investigational Site
state: California
city: San Diego
country: United States
facility: Watson Investigational Site
state: California
city: Denver
country: United States
facility: Watson Investigational Site
state: Colorado
city: Washington DC
country: United States
facility: Watson Investigational Site
state: District of Columbia
city: Detroit
country: United States
facility: Watson Investigational Site
state: Michigan
city: Mineapolis
country: United States
facility: Watson Investigational Site
state: Minnesota
city: Jackson
country: United States
facility: Watson Investigational Site
state: Mississippi
city: Kansas City
country: United States
facility: Watson Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Watson Investigational Site
state: Missouri
city: Voorhees
country: United States
facility: Watson Investigational Site
state: New Jersey
city: Albany
country: United States
facility: Watson Investigational Site
state: New York
city: Buffalo
country: United States
facility: Watson Investigational Site
state: New York
city: Poughkeepsie
country: United States
facility: Watson Investigational Site
state: New York
city: Ashville
country: United States
facility: Watson Investigational Site
state: North Carolina
city: Durham
country: United States
facility: Watson Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Watson Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Watson Investigational Site
state: Oklahoma
city: Hershy
country: United States
facility: Watson Investigational Site
state: Pennsylvania
city: Dallas
country: United States
facility: Watson Investigational Site
state: Texas
city: Houston
country: United States
facility: Watson Investigational Site
state: Texas
city: Plano
country: United States
facility: Watson Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Watson Investigational Site
state: Utah
Study officials:
affiliation: Watson Laboratories, Inc.
name: Gary Hoel, RPh, PhD
role: STUDY_CHAIR
References:
citation: 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.