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

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ClinicalTrials.gov Identifier: NCT01192568
Recruitment Status : Recruiting
First Posted : September 1, 2010
Last Update Posted : October 19, 2017
Information provided by (Responsible Party):
Allergan ( Allergan Sales, LLC )

Brief Summary:
This study will evaluate the safety and efficacy of Oxybutynin Chloride 10% Topical Gel in children 3 to less than 17 years old, who have overactive bladder due to a neurogenic condition. Children will be treated with 0.75 g of gel/day for two weeks. Patients will then return to the clinic for a potential dose titration. At this time their dose may be adjusted up to 1g/day, down to 0.5g/day, or remain the same at 0.75g of gel/day depending on the individual response and tolerability. The total treatment time is 14 weeks and total time on the study is 16 weeks.

Condition or disease Intervention/treatment Phase
Overactive Detrusor Neurogenic Bladder Drug: Oxybutynin Phase 4

Detailed Description:
This study will use a two-part, multicenter, dose-titration study in pediatric patients with a detrusor overactivity associated with a neurological condition

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Two-part, Multicenter, Dose-titration Study Evaluating Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of Oxybutynin Chloride 10% Gel for Treatment of Detrusor Overactivity Associated Neurological Condition in Pediatric Patients
Actual Study Start Date : May 2, 2011
Estimated Primary Completion Date : June 12, 2020
Estimated Study Completion Date : June 12, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Percentage of catheterizations without a leaking accident. [ Time Frame: baseline (week 0) up to week 6 ]
    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.

Secondary Outcome Measures :
  1. Average volume of urine collected per catheterization (for Pre-Amendment 3 population only) [ Time Frame: baseline (week 0) up to week 6 ]
    The Pre-Amendment 3 population included pediatric patients, from ages 6 years to < 17 years, who had a diagnosis of detrusor overactivity associated with a neurological condition and were using CIC to control bladder function

  2. Average volume of urine collected at first (morning awakening) catheterization [ Time Frame: baseline (week 0) up to week 6 ]
  3. Average number of catheterizations per day [ Time Frame: baseline (week 0) up to week 6 ]
  4. Average volume of urine collected per catheterization [ Time Frame: baseline (week 0) up to week 6 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 3 years to < 17 years
  • Neurogenic bladder
  • Neurological condition
  • CIC

Exclusion Criteria:

  • Have anatomical bladder abnormalities
  • Sensitivity to anticholinergics
  • Bladder augmentation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01192568

Contact: Clinical Trials Registry Team 1-877-277-8566 IR-CTRegistration@allergan.com

United States, California
Investigational Site Not yet recruiting
Loma Linda, California, United States
Investigational Site Terminated
Long Beach, California, United States
Children's Hospital of Orange County Recruiting
Orange, California, United States, 92868
United States, Colorado
Urology Associates Recruiting
Englewood, Colorado, United States, 80113
United States, Michigan
Investigational Site Not yet recruiting
Detroit, Michigan, United States
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28207
Associated Urologists of North Carolina Recruiting
Raleigh, North Carolina, United States, 27612
United States, Ohio
Investigational Site Terminated
Akron, Ohio, United States
United States, Virginia
Children's Hospital of the King's Daughters Recruiting
Norfolk, Virginia, United States, 26507
Puerto Rico
Centro de Investigaciones Clinicas, San Jorge Children's Hospital Active, not recruiting
San Juan, Puerto Rico, 00912
Sponsors and Collaborators
Allergan Sales, LLC
Study Director: William Ferguson Allergan Sales, LLC

Responsible Party: Allergan Sales, LLC
ClinicalTrials.gov Identifier: NCT01192568     History of Changes
Other Study ID Numbers: OG09002
First Posted: September 1, 2010    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017

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