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

NCT ID: NCT01192568

Last Updated: 2024-09-04

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-17

Study Completion Date

2023-10-24

Brief Summary

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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.

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Detailed Description

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This study will use a two-part, multicenter, dose-titration study in pediatric patients with a detrusor overactivity associated with a neurological condition

Conditions

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Overactive Detrusor Neurogenic Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

This study was initiated as a double-blind, placebo-controlled study with an open-label extension and was amended (in Protocol Amendment 3) to continue to enroll subjects under only open-label treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Pre-Amendment 3: All subjects, site personnel and Watson and CRO personnel directly involved in the execution of the study were blinded. Post-Amendment 3: All subjects Open-label

Study Groups

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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.

Group Type EXPERIMENTAL

Oxybutynin

Intervention Type DRUG

10% Oxybutynin Chloride Topical Gel, 0.5 g, 0.75 g, and 1 g/day, administered transdermally.

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.

Group Type EXPERIMENTAL

Oxybutynin

Intervention Type DRUG

10% Oxybutynin Chloride Topical Gel, 0.5 g, 0.75 g, and 1 g/day, administered transdermally.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Topical gel

Interventions

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Oxybutynin

10% Oxybutynin Chloride Topical Gel, 0.5 g, 0.75 g, and 1 g/day, administered transdermally.

Intervention Type DRUG

Placebo

Topical gel

Intervention Type DRUG

Other Intervention Names

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Gelnique

Eligibility Criteria

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Inclusion Criteria

* 3 years to \< 17 years
* Neurogenic bladder
* Neurological condition
* CIC

Exclusion Criteria

* Have anatomical bladder abnormalities
* Sensitivity to anticholinergics
* Bladder augmentation
Minimum Eligible Age

3 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Loma Linda University /ID# 236889

Loma Linda, California, United States

Site Status

Child Hosp of Orange County,CA /ID# 237517

Orange, California, United States

Site Status

Children's Hospital Colorado - Aurora /ID# 237620

Aurora, Colorado, United States

Site Status

Augusta University Medical Center /ID# 238188

Augusta, Georgia, United States

Site Status

University of Mississippi Medical Center /ID# 238065

Jackson, Mississippi, United States

Site Status

Albany Medical College /ID# 236880

Albany, New York, United States

Site Status

Duke University /ID# 237494

Durham, North Carolina, United States

Site Status

Duplicate_Oregon Health & Science University /ID# 234354

Portland, Oregon, United States

Site Status

Cook Children's Med. Center /ID# 237538

Fort Worth, Texas, United States

Site Status

Child Hosp of the King's Dtr's /ID# 237799

Norfolk, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19683731 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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OG09002

Identifier Type: -

Identifier Source: org_study_id

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