Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder
Information source: Watson Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Overactive Detrusor; Neurogenic Bladder
Intervention: Oxybutynin (Drug)
Phase: Phase 4
Status: Suspended
Sponsored by: Watson Pharmaceuticals Official(s) and/or principal investigator(s):
Branka Palic, Study Director, Affiliation: Actavis Inc.
Summary
This study will evaluate the safety and efficacy of Oxybutynin Topical Gel in children who
have a neurogenic bladder. Children will be treated with placebo or active drug for 6 weeks
and then all children will be switched to active drug for an additional 8 weeks.
Clinical Details
Official title: A Multi-Center, Double-Blind, Placebo-Controlled, Dose-Titration Study Evaluating the Efficacy, Safety, PD and PK of Oxybutynin Chloride Topical Gel for Detrusor Overactivity Associated With a Neurological Condition in Pediatric Subjects
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Percentage of catheterizations without a leaking accident.
Detailed description:
This study will use a multicenter, double-blind, placebo-controlled, dose-titration study in
pediatric subjects with detrusor overactivity associated with a neurological condition.
Eligibility
Minimum age: 6 Years.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Neurogenic bladder
- Neurological condition
- CIC
Exclusion Criteria:
- Have anatomical bladder abnormalities
- Sensitivity to anticholinergics
- Bladder augmentation
Locations and Contacts
Watson Investigational Site, Loma Linda, California, United States
Watson Investigational Site, Long Beach, California, United States
Watson Investigational Site, Los Angeles, California, United States
Watson Investigational Site, Madera, California, United States
Watson Investigational Site, San Diego, California, United States
Watson Investigational Site, Washington, District of Columbia, United States
Watson Investigational Site, Miami, Florida, United States
Watson Investigational Site, Atlanta, Georgia, United States
Watson Investigational Site, Shreveport, Louisiana, United States
Watson Investigational Site, Detroit, Michigan, United States
Watson Investigational Site, Charlotte, North Carolina, United States
Watson Investigational Site, Winston-Salem, North Carolina, United States
Watson Investigational Site, Akron, Ohio, United States
Watson Investigational Site, Cincinnati, Ohio, United States
Watson Investigational Site, Cleveland, Ohio, United States
Watson Investigational Site, Portland, Oregon, United States
Watson Investigational Site, Charleston, South Carolina, United States
Watson Investigational Site, Nashville, Tennessee, United States
Watson Investigational Site, Charlottesville, Virginia, United States
Watson Investigational Site, Norfolk, Virginia, United States
Watson Investigational Site, Richmond, Virginia, United States
Additional Information
Related publications: 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. Erratum in: J Urol. 2009 Dec;182(6):2985. Dosage error in article text.
Starting date: June 2011
Last updated: May 28, 2015
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