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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01192568
Recruitment Status : Recruiting
First Posted : September 1, 2010
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: N/A
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 : April 27, 2021
Estimated Study Completion Date : April 27, 2021

Resource links provided by the National Library of Medicine


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
Criteria

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


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

Locations
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United States, California
Loma Linda University Health Recruiting
Loma Linda, California, United States, 92354
Contact: Site Coordinator    909-558-5830      
Atlantic Urology Medical Group Terminated
Long Beach, California, United States, 90806
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Site Coordinator    310-423-6996      
Children's Hospital of Orange County Recruiting
Orange, California, United States, 92868
Contact: Site Coordinator    714-509-8810      
United States, Colorado
Urology Associates Withdrawn
Englewood, Colorado, United States, 80113
United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Site Coordinator    706-721-5636      
United States, Michigan
Children's Hospital of Michigan Terminated
Detroit, Michigan, United States, 48201
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Site Coordinator    601-815-5689      
United States, New York
Albany Medical College Recruiting
Albany, New York, United States, 12208
Contact: Site Coordinator    518-262-8579      
United States, North Carolina
Carolinas Medical Center Withdrawn
Charlotte, North Carolina, United States, 28207
Associated Urologists of North Carolina Withdrawn
Raleigh, North Carolina, United States, 27612
United States, Ohio
Children's Hospital Medical Center of Akron Terminated
Akron, Ohio, United States, 44308
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Site Coordinator    503-494-8216      
United States, Texas
Texas Children's Hospital - BCM Withdrawn
Houston, Texas, United States, 77030
United States, Virginia
Children's Hospital of the King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Contact: Site Coordinator    757-668-7807      
Puerto Rico
Centro de Investigaciones Clinicas, San Jorge Children's Hospital Withdrawn
San Juan, Puerto Rico, 00912
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Anna Chan Allergan Sales, LLC
Publications:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01192568    
Other Study ID Numbers: OG09002
First Posted: September 1, 2010    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Additional relevant MeSH terms:
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Urinary Bladder, Neurogenic
Urinary Bladder, Overactive
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Oxybutynin
Parasympatholytics
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