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

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: Overactive Detrusor; Neurogenic Bladder
• Intervention / Treatment: Drug: Oxybutynin; Drug: Placebo

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): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University /ID# 236889
    • Orange, California, United States, 92868
      • Child Hosp of Orange County,CA /ID# 237517
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado - Aurora /ID# 237620
  • Georgia
    • Augusta, Georgia, United States, 30912-0004
      • Augusta University Medical Center /ID# 238188
  • Mississippi
    • Jackson, Mississippi, United States, 39216-4500
      • University of Mississippi Medical Center /ID# 238065
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College /ID# 236880
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University /ID# 237494
  • Oregon
    • Portland, Oregon, United States, 97239-3011
      • Duplicate_Oregon Health & Science University /ID# 234354
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Cook Children's Med. Center /ID# 237538
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Child Hosp of the King's Dtr's /ID# 237799

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DB: OTG (Pre-Amend 3); Double-Blind Oxybutynin Chloride topical gel (OTG) (Pre-Amendment 3) Oxybutynin Chloride topical gel (OTG), 0.5 g, 0.75 g (starting dose), or 1 g sachets, applied transdermally once daily for 6 weeks. Followed by OL OTG for 8 weeks.	Drug: Oxybutynin; 10% Oxybutynin Chloride Topical Gel, 0.5 g, 0.75 g, and 1 g/day, administered transdermally.; Other Names: Gelnique
Experimental: OL: OTG (Post-Amend 3); Open-Label Oxybutynin Chloride topical gel (OTG) (Pre & Post-Amendment 3) Oxybutynin Chloride topical gel (OTG), 0.5 g, 0.75 g (starting dose for Pre- and Post-Amendment 3), or 1 g sachets, applied transdermally once daily for 14 weeks.	Drug: Oxybutynin; 10% Oxybutynin Chloride Topical Gel, 0.5 g, 0.75 g, and 1 g/day, administered transdermally.; Other Names: Gelnique
Placebo Comparator: DB: Placebo (Pre-Amend 3); Double-Blind Placebo (Pre-Amendment 3) Placebo Gel sachets applied transdermally once daily for 6 weeks. Followed by OL OTG for 8 weeks.	Drug: Placebo; Topical gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Percent of Catheterizations Without a Leaking Accident at 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
Change From Baseline in Average Volume of Urine Collected Per Catheterization at Week 6	Pre-Amendment 3: Change from Baseline in Average Volume of Urine Collected per Catheterization at week 6 (calculated from the 2-day urinary diary data).	Baseline (Week 0) up to week 6
Change From Baseline in Average Volume of Urine Collected Per First (Morning Awakening) Catheterization at Week 6	Change from Baseline in Average Volume of Urine Collected Per First (Morning Awakening) Catheterization at week 6 (calculated from the 2-day urinary diary data).	Baseline (Week 0) up to Week 6
Change From Baseline in Average Number of Catheterizations Per Day at Week 6	Change from Baseline in Average Number of Catheterizations Per Day at Week 6 (calculated from the 2-day urinary diary data).	Baseline (Week 0) up to Week 6

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2011
• Primary Completion (Actual): August 29, 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): September 4, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: August 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