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Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder

This study is currently recruiting participants.
Verified March 2013 by Watson Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01192568
First received: August 30, 2010
Last updated: March 20, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Overactive Detrusor
Neurogenic Bladder
 Drug: Oxybutynin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:
  • Percentage of catheterizations without a leaking accident. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The primary efficacy endpoint is the change from baseline to Week 6 of treatment or the last observation carried forward in percentage of catheterizations without a leaking accident as recorded in a 2-day urinary diary.


Estimated Enrollment: 96
Study Start Date: June 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxybutynin Chloride Drug: Oxybutynin
10% Oxybutynin Chloride Topical Gel, 0.5 g, 0.75 g, and 1 g/day, administered transdermally.
Other Name: Gelnique
Experimental: Placebo Drug: Oxybutynin
10% Oxybutynin Chloride Topical Gel, 0.5 g, 0.75 g, and 1 g/day, administered transdermally.
Other Name: Gelnique

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

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Neurogenic bladder
  • Neurological condition
  • CIC

Exclusion Criteria:

  • Have anatomical bladder abnormalities
  • Sensitivity to anticholinergics
  • Bladder augmentation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01192568

Contacts
Contact: Lawrence A Hill, PhamD, MBA 8015886386 lawrence.hill@watson.com
Contact: Lawrence Hill, PharmD, RPh 8015886386

Locations
United States, California
Watson Investigational Site Not yet recruiting
Loma Linda, California, United States
Watson Investigational Site Recruiting
Los Angeles, California, United States
Watson Investigational Site Recruiting
Madera, California, United States
Watson Investigational Site Not yet recruiting
San Diego, California, United States
United States, District of Columbia
Watson Investigational Site Not yet recruiting
Washington, District of Columbia, United States
United States, Florida
Watson Investigational Site Not yet recruiting
Miami, Florida, United States
United States, Georgia
Watson Investigational Site Not yet recruiting
Atlanta, Georgia, United States
United States, Michigan
Watson Investigational Site Not yet recruiting
Detroit, Michigan, United States
United States, North Carolina
Watson Investigational Site Recruiting
Charlotte, North Carolina, United States
Watson Investigational Site Not yet recruiting
Winston-Salem, North Carolina, United States
United States, Ohio
Watson Investigational Site Recruiting
Akron, Ohio, United States
Watson Investigational Site Recruiting
Cincinnati, Ohio, United States
Watson Investigational Site Not yet recruiting
Cleveland, Ohio, United States
United States, Oregon
Watson Investigational Site Not yet recruiting
Portland, Oregon, United States
United States, South Carolina
Watson Investigational Site Recruiting
Charleston, South Carolina, United States
United States, Tennessee
Watson Investigational Site Not yet recruiting
Nashville, Tennessee, United States
United States, Virginia
Watson Investigational Site Not yet recruiting
Charlottesville, Virginia, United States
Watson Investigational Site Not yet recruiting
Richmond, Virginia, United States
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
Study Director: Lawrence A Hill, PhamD, MBA Watson Pharmaceuticals
  More Information

Publications:

Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01192568     History of Changes
Other Study ID Numbers: OG09002
Study First Received: August 30, 2010
Last Updated: March 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Bladder, Neurogenic
Urinary Bladder, Overactive
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms
Urological Manifestations
Oxybutynin
Mandelic Acids
Parasympatholytics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Renal Agents

ClinicalTrials.gov processed this record on May 19, 2013