Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition
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
1 other identifier
interventional
57
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2004
Longer than P75 for phase_4
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedResults Posted
Study results publicly available
December 23, 2009
CompletedFebruary 9, 2012
February 1, 2012
2.3 years
September 13, 2005
November 13, 2009
February 7, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Average Catheterization Urine Volume
Change from baseline in average volume of urine collected by catheterization
14 weeks
Secondary Outcomes (2)
Catheterizations Without Leakage
14 weeks
Urine Volume After First Awakening
14 weeks
Study Arms (2)
Oxybutynin Transdermal System
EXPERIMENTALOxybutynin Transdermal System 1.3 mg/day, 2.6 mg/day, or 3.9 mg/day
Oral oxybutynin
ACTIVE COMPARATOR5 to 15 mg/day immediate release or extended release tablets, or syrup
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
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 D.C., District of Columbia, United States
Watson Investigational Site
Detroit, Michigan, United States
Watson Investigational Site
Minneapolis, 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 Township, 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
Related 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.
PMID: 19683731RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The transdermal groups included more males and younger subjects. The study was not designed to compare the transdermal and oral groups. Advserse event data reported for the titration and maintenance periods.
Results Point of Contact
- Title
- Gary Hoel, RPh, PhD, Executive Director of Clinical Research
- Organization
- Watson Laboratories, Inc
Study Officials
- STUDY CHAIR
Gary Hoel, RPh, PhD
Watson Laboratories, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 22, 2005
Study Start
December 1, 2004
Primary Completion
April 1, 2007
Study Completion
September 1, 2008
Last Updated
February 9, 2012
Results First Posted
December 23, 2009
Record last verified: 2012-02