Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder
Primary Purpose
Overactive Detrusor, Neurogenic Bladder
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Oxybutynin
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Detrusor
Eligibility Criteria
Inclusion Criteria:
- 3 years to < 17 years
- Neurogenic bladder
- Neurological condition
- CIC
Exclusion Criteria:
- Have anatomical bladder abnormalities
- Sensitivity to anticholinergics
- Bladder augmentation
Sites / Locations
- Loma Linda University /ID# 236889
- Child Hosp of Orange County,CA /ID# 237517
- Children's Hospital Colorado /ID# 237620Recruiting
- Augusta University Medical Center /ID# 238188
- University of Mississippi Medical Center /ID# 238065Recruiting
- Albany Medical College /ID# 236880
- SUNY Upstate Medical University /ID# 245705
- Duke University /ID# 237494Recruiting
- Oregon Health & Science University /ID# 234354
- Penn State University and Milton S. Hershey Medical Center /ID# 245850
- Cook Children's Med. Center /ID# 237538
- Children's Hospital Wisconsin - Milwaukee Campus /ID# 245783
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oxybutynin Chloride
Arm Description
Outcomes
Primary Outcome Measures
Percentage of catheterizations without a leaking accident.
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
Average volume of urine collected per catheterization (for Pre-Amendment 3 population only)
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
Average volume of urine collected at first (morning awakening) catheterization
Average number of catheterizations per day
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01192568
Brief Title
Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder
Official Title
A Two-part, Multicenter, Dose-titration Study Evaluating the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of Oxybutynin Chloride 10% Gel for the Treatment of Detrusor Overactivity Associated With a Neurological Condition in Pediatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2011 (Actual)
Primary Completion Date
November 3, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Detrusor, Neurogenic Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oxybutynin Chloride
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oxybutynin
Other Intervention Name(s)
Gelnique
Intervention Description
10% Oxybutynin Chloride Topical Gel, 0.5 g, 0.75 g, and 1 g/day, administered transdermally.
Primary Outcome Measure Information:
Title
Percentage of catheterizations without a leaking accident.
Description
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.
Time Frame
baseline (week 0) up to week 6
Secondary Outcome Measure Information:
Title
Average volume of urine collected per catheterization (for Pre-Amendment 3 population only)
Description
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
Time Frame
baseline (week 0) up to week 6
Title
Average volume of urine collected at first (morning awakening) catheterization
Time Frame
baseline (week 0) up to week 6
Title
Average number of catheterizations per day
Time Frame
baseline (week 0) up to week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
3 years to < 17 years
Neurogenic bladder
Neurological condition
CIC
Exclusion Criteria:
Have anatomical bladder abnormalities
Sensitivity to anticholinergics
Bladder augmentation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Loma Linda University /ID# 236889
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Completed
Facility Name
Child Hosp of Orange County,CA /ID# 237517
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Completed
Facility Name
Children's Hospital Colorado /ID# 237620
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Augusta University Medical Center /ID# 238188
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912-0004
Country
United States
Individual Site Status
Completed
Facility Name
University of Mississippi Medical Center /ID# 238065
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4500
Country
United States
Individual Site Status
Recruiting
Facility Name
Albany Medical College /ID# 236880
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Completed
Facility Name
SUNY Upstate Medical University /ID# 245705
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Duke University /ID# 237494
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Oregon Health & Science University /ID# 234354
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3011
Country
United States
Individual Site Status
Completed
Facility Name
Penn State University and Milton S. Hershey Medical Center /ID# 245850
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-2360
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Cook Children's Med. Center /ID# 237538
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Completed
Facility Name
Children's Hospital Wisconsin - Milwaukee Campus /ID# 245783
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing 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/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Citations:
PubMed Identifier
19683731
Citation
Cartwright PC, Coplen DE, Kogan BA, Volinn W, Finan E, Hoel G. Efficacy and safety of transdermal and oral oxybutynin in children with neurogenic detrusor overactivity. J Urol. 2009 Oct;182(4):1548-54. doi: 10.1016/j.juro.2009.06.058. Epub 2009 Aug 15. Erratum In: J Urol. 2009 Dec;182(6):2985. Dosage error in article text.
Results Reference
background
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Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder
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