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NCT Number: NCT01192568

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

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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Key information

Conditions

Overactive Detrusor Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Nervous System Diseases Neurogenic Bladder Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Neurogenic Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Loma Linda University /ID# 236889, Loma Linda, California, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 3 years to < 17 years
  • Neurogenic bladder
  • Neurological condition
  • CIC

Exclusion criteria

  • Have anatomical bladder abnormalities
  • Sensitivity to anticholinergics
  • Bladder augmentation

Treatment and study plan

Oxybutynin

Drug

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

Other names: Gelnique

Placebo

Drug

Topical gel

Primary outcomes

  1. Change From Baseline in Percent of Catheterizations Without a Leaking Accident at Week 6

    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 outcomes

  1. Change From Baseline in Average Volume of Urine Collected Per Catheterization at Week 6

    Time frame: Baseline (Week 0) up to 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).

  2. Change From Baseline in Average Volume of Urine Collected Per First (Morning Awakening) Catheterization at Week 6

    Time frame: Baseline (Week 0) up to 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).

  3. Change From Baseline in Average Number of Catheterizations Per Day at Week 6

    Time frame: Baseline (Week 0) up to Week 6

    Change from Baseline in Average Number of Catheterizations Per Day at Week 6 (calculated from the 2-day urinary diary data).

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2023
Study completion
2023
First posted
Sep 1, 2010
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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