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Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition

Primary Purpose

Detrusor Hyperreflexia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Oxybutynin
Oxybutynin
Sponsored by
Watson Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Detrusor Hyperreflexia

Eligibility Criteria

6 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oxybutynin Transdermal System

Oral oxybutynin

Arm Description

Oxybutynin Transdermal System 1.3 mg/day, 2.6 mg/day, or 3.9 mg/day

5 to 15 mg/day immediate release or extended release tablets, or syrup

Outcomes

Primary Outcome Measures

Average Catheterization Urine Volume
Change from baseline in average volume of urine collected by catheterization

Secondary Outcome Measures

Catheterizations Without Leakage
Percentage of catherizations without leakage
Urine Volume After First Awakening
Change from baseline in average volume of urine collected after first morning awakening

Full Information

First Posted
September 13, 2005
Last Updated
February 7, 2012
Sponsor
Watson Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00224016
Brief Title
Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition
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 Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Watson Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Detrusor Hyperreflexia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxybutynin Transdermal System
Arm Type
Experimental
Arm Description
Oxybutynin Transdermal System 1.3 mg/day, 2.6 mg/day, or 3.9 mg/day
Arm Title
Oral oxybutynin
Arm Type
Active Comparator
Arm Description
5 to 15 mg/day immediate release or extended release tablets, or syrup
Intervention Type
Drug
Intervention Name(s)
Oxybutynin
Other Intervention Name(s)
Oxytrol
Intervention Description
1.3, 2.6, 3.9 mg/day transdermal
Intervention Type
Drug
Intervention Name(s)
Oxybutynin
Other Intervention Name(s)
Ditropan, Ditropan XL, Oxybutynin
Intervention Description
5 to 15 mg/day immediate release or extended release tablets, or syrup
Primary Outcome Measure Information:
Title
Average Catheterization Urine Volume
Description
Change from baseline in average volume of urine collected by catheterization
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Catheterizations Without Leakage
Description
Percentage of catherizations without leakage
Time Frame
14 weeks
Title
Urine Volume After First Awakening
Description
Change from baseline in average volume of urine collected after first morning awakening
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Hoel, RPh, PhD
Organizational Affiliation
Watson Laboratories, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Watson Investigational Site
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Watson Investigational Site
City
Orange County
State/Province
California
Country
United States
Facility Name
Watson Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Watson Investigational Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Watson Investigational Site
City
Washington DC
State/Province
District of Columbia
Country
United States
Facility Name
Watson Investigational Site
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Watson Investigational Site
City
Mineapolis
State/Province
Minnesota
Country
United States
Facility Name
Watson Investigational Site
City
Jackson
State/Province
Mississippi
Country
United States
Facility Name
Watson Investigational Site
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Watson Investigational Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Watson Investigational Site
City
Voorhees
State/Province
New Jersey
Country
United States
Facility Name
Watson Investigational Site
City
Albany
State/Province
New York
Country
United States
Facility Name
Watson Investigational Site
City
Buffalo
State/Province
New York
Country
United States
Facility Name
Watson Investigational Site
City
Poughkeepsie
State/Province
New York
Country
United States
Facility Name
Watson Investigational Site
City
Ashville
State/Province
North Carolina
Country
United States
Facility Name
Watson Investigational Site
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Watson Investigational Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Watson Investigational Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Watson Investigational Site
City
Hershy
State/Province
Pennsylvania
Country
United States
Facility Name
Watson Investigational Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Watson Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Watson Investigational Site
City
Plano
State/Province
Texas
Country
United States
Facility Name
Watson Investigational Site
City
Salt Lake City
State/Province
Utah
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19683731
Citation
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.
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Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition

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