Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition
Information source: Watson Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Detrusor Hyperreflexia
Intervention: Oxybutynin (Drug); Oxybutynin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Watson Pharmaceuticals Official(s) and/or principal investigator(s):
Gary Hoel, RPh, PhD, Study Chair, 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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Average Catheterization Urine Volume
Secondary outcome: Catheterizations Without LeakageUrine Volume After First Awakening
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
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
Watson Investigational Site, Little Rock, Arkansas, United States
Watson Investigational Site, Orange County, California, United States
Watson Investigational Site, San Diego, California, United States
Watson Investigational Site, Denver, Colorado, United States
Watson Investigational Site, Washington DC, District of Columbia, United States
Watson Investigational Site, Detroit, Michigan, United States
Watson Investigational Site, Mineapolis, Minnesota, United States
Watson Investigational Site, Jackson, Mississippi, United States
Watson Investigational Site, Kansas City, Missouri, United States
Watson Investigational Site, St. Louis, Missouri, United States
Watson Investigational Site, Voorhees, New Jersey, United States
Watson Investigational Site, Albany, New York, United States
Watson Investigational Site, Buffalo, New York, United States
Watson Investigational Site, Poughkeepsie, New York, United States
Watson Investigational Site, Ashville, North Carolina, United States
Watson Investigational Site, Durham, North Carolina, United States
Watson Investigational Site, Columbus, Ohio, United States
Watson Investigational Site, Oklahoma City, Oklahoma, United States
Watson Investigational Site, Hershy, Pennsylvania, United States
Watson Investigational Site, Dallas, Texas, United States
Watson Investigational Site, Houston, Texas, United States
Watson Investigational Site, Plano, Texas, United States
Watson Investigational Site, Salt Lake City, Utah, United States
Additional Information
Starting date: December 2004
Last updated: February 7, 2012
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