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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 : November 14, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

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 : November 3, 2023
Estimated Study Completion Date : December 30, 2023

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 ]


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: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
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United States, California
Loma Linda University /ID# 236889 Completed
Loma Linda, California, United States, 92354
Child Hosp of Orange County,CA /ID# 237517 Completed
Orange, California, United States, 92868
United States, Colorado
Children's Hospital Colorado /ID# 237620 Recruiting
Aurora, Colorado, United States, 80045
Contact: Site Coordinator    844-663-3742      
United States, Georgia
Augusta University Medical Center /ID# 238188 Completed
Augusta, Georgia, United States, 30912-0004
United States, Mississippi
University of Mississippi Medical Center /ID# 238065 Recruiting
Jackson, Mississippi, United States, 39216-4500
United States, New York
Albany Medical College /ID# 236880 Recruiting
Albany, New York, United States, 12208
Contact: Site Coordinator    844-663-3742      
SUNY Upstate Medical University /ID# 245705 Not yet recruiting
Syracuse, New York, United States, 13210
United States, North Carolina
Duke University /ID# 237494 Recruiting
Durham, North Carolina, United States, 27710
Contact: Site Coordinator    844-663-3742      
United States, Oregon
Oregon Health & Science University /ID# 234354 Completed
Portland, Oregon, United States, 97239-3011
United States, Texas
Cook Children's Med. Center /ID# 237538 Recruiting
Fort Worth, Texas, United States, 76104
Contact: Site Coordinator    844-663-3742      
Texas Children's Hospital /ID# 238303 Not yet recruiting
Houston, Texas, United States, 77030-2608
Contact: Site Coordinator    844-663-3742      
United States, Wisconsin
Children's Hospital Wisconsin - Milwaukee Campus /ID# 245783 Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
Publications:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01192568    
Other Study ID Numbers: OG09002
First Posted: September 1, 2010    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
URL: https://vivli.org/ourmember/abbvie/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
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