Status:
COMPLETED
Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition
Lead Sponsor:
Watson Pharmaceuticals
Conditions:
Detrusor Hyperreflexia
Eligibility:
All Genders
6-15 years
Phase:
PHASE4
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 (...
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 ne...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00224016
Start Date
December 1 2004
End Date
September 1 2008
Last Update
February 9 2012
Active Locations (23)
Enter a location and click search to find clinical trials sorted by distance.
1
Watson Investigational Site
Little Rock, Arkansas, United States
2
Watson Investigational Site
Orange County, California, United States
3
Watson Investigational Site
San Diego, California, United States
4
Watson Investigational Site
Denver, Colorado, United States