A Study Evaluating the Safety, Effectiveness, and Pharmacokinetics of Transdermal Oxybutynin in Treating Overactive Bladder Associated With a Neurological Condition
Information source: Watson Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Detrusor Hyperreflexia
Intervention: Oxybutynin (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Watson Pharmaceuticals Official(s) and/or principal investigator(s):
Gary Hoel, RPh, PhD, Affiliation: Watson Laboratories, Inc.
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.
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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Measures of incontinence and leakage
Secondary outcome: Safety, patch adhesion
Eligibility
Minimum age: 6 Years.
Maximum age: 15 Years.
Gender(s): Both.
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
Locations and Contacts
Little Rock, Arkansas, United States
San Diego, California, United States
Orange County, California, United States
Denver, Colorado, United States
Washington DC, District of Columbia, United States
Detroit, Michigan, United States
Mineapolis, Minnesota, United States
Jackson, Mississippi, United States
St. Louis, Missouri, United States
Kansas City, Missouri, United States
Voorhees, New Jersey, United States
Buffalo, New York, United States
Albany, New York, United States
Poughkeepsie, New York, United States
Durham, North Carolina, United States
Ashville, North Carolina, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Hershy, Pennsylvania, United States
Houston, Texas, United States
Plano, Texas, United States
Dallas, Texas, United States
Salt Lake City, Utah, United States
Additional Information
Starting date: December 2004
Last updated: September 7, 2007
|
