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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2021

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

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Oxybutynin Chloride

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • Average volume of urine collected at first (morning awakening) catheterization
    • Time Frame: baseline (week 0) up to week 6
  • Average number of catheterizations per day
    • Time Frame: baseline (week 0) up to week 6
  • Average volume of urine collected per catheterization
    • Time Frame: baseline (week 0) up to week 6

Participating in This Clinical Trial

Inclusion Criteria

  • 3 years to < 17 years – Neurogenic bladder – Neurological condition – CIC Exclusion Criteria:
  • Have anatomical bladder abnormalities – Sensitivity to anticholinergics – Bladder augmentation
  • Gender Eligibility: All

    Minimum Age: 3 Years

    Maximum Age: 16 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Allergan
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Anna Chan, Study Director, Allergan Sales, LLC
    • Overall Contact(s)
      • Clinical Trials Registry Team, 1-877-277-8566, IR-CTRegistration@allergan.com

    References

    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.

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