- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01192568
Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder
January 15, 2024 updated by: AbbVie
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
19
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
-
Loma Linda, California, United States, 92354
- Loma Linda University /ID# 236889
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Orange, California, United States, 92868
- Child Hosp of Orange County,CA /ID# 237517
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Colorado
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Aurora, Colorado, United States, 80045
- Children's Hospital Colorado /ID# 237620
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Georgia
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Augusta, Georgia, United States, 30912-0004
- Augusta University Medical Center /ID# 238188
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Mississippi
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Jackson, Mississippi, United States, 39216-4500
- University of Mississippi Medical Center /ID# 238065
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New York
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Albany, New York, United States, 12208
- Albany Medical College /ID# 236880
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University /ID# 237494
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Oregon
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Portland, Oregon, United States, 97239-3011
- Oregon Health & Science University /ID# 234354
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Texas
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Fort Worth, Texas, United States, 76104
- Cook Children's Med. Center /ID# 237538
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 16 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 3 years to < 17 years
- Neurogenic bladder
- Neurological condition
- CIC
Exclusion Criteria:
- Have anatomical bladder abnormalities
- Sensitivity to anticholinergics
- Bladder augmentation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oxybutynin Chloride
|
10% Oxybutynin Chloride Topical Gel, 0.5 g, 0.75 g, and 1 g/day, administered transdermally.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline (week 0) up to week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline (week 0) up to week 6
|
Average volume of urine collected at first (morning awakening) catheterization
Time Frame: baseline (week 0) up to week 6
|
baseline (week 0) up to week 6
|
|
Average number of catheterizations per day
Time Frame: baseline (week 0) up to week 6
|
baseline (week 0) up to week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: ABBVIE INC., AbbVie
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 2, 2011
Primary Completion (Actual)
August 26, 2023
Study Completion (Actual)
October 24, 2023
Study Registration Dates
First Submitted
August 30, 2010
First Submitted That Met QC Criteria
August 31, 2010
First Posted (Estimated)
September 1, 2010
Study Record Updates
Last Update Posted (Actual)
January 17, 2024
Last Update Submitted That Met QC Criteria
January 15, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Urologic Diseases
- Urinary Bladder Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Neurologic Manifestations
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Urinary Bladder, Overactive
- Urinary Bladder, Neurogenic
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Urological Agents
- Oxybutynin
Other Study ID Numbers
- OG09002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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 Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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