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

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01192568
First received: August 30, 2010
Last updated: May 28, 2015
Last verified: May 2015
  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:


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: June 2020
Estimated Primary Completion Date: August 2019 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192568

Locations
United States, California
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
United States, District of Columbia
Watson Investigational Site
Washington, District of Columbia, United States
United States, Florida
Watson Investigational Site
Miami, Florida, United States
United States, Georgia
Watson Investigational Site
Atlanta, Georgia, United States
United States, Louisiana
Watson Investigational Site
Shreveport, Louisiana, United States
United States, Michigan
Watson Investigational Site
Detroit, Michigan, United States
United States, North Carolina
Watson Investigational Site
Charlotte, North Carolina, United States
Watson Investigational Site
Winston-Salem, North Carolina, United States
United States, Ohio
Watson Investigational Site
Akron, Ohio, United States
Watson Investigational Site
Cincinnati, Ohio, United States
Watson Investigational Site
Cleveland, Ohio, United States
United States, Oregon
Watson Investigational Site
Portland, Oregon, United States
United States, South Carolina
Watson Investigational Site
Charleston, South Carolina, United States
United States, Tennessee
Watson Investigational Site
Nashville, Tennessee, United States
United States, Virginia
Watson Investigational Site
Charlottesville, Virginia, United States
Watson Investigational Site
Norfolk, Virginia, United States
Watson Investigational Site
Richmond, Virginia, United States
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
Study Director: Branka Palic Actavis Inc.
  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: May 28, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 30, 2015