CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 57 enrolled
Drug / intervention
Oxybutynin +1 moredrug
Likely dose
Oxybutynin transdermal 1.3 to 3.9 mg/day (experimental arm) or oxybutynin oral 5 to 15 mg/day (active control)AI-extracted
Key inclusion· 3
  • ✓Pediatric patient with detrusor overactivity associated with a neurological condition
  • ✓Currently using clean intermittent catheterization
  • ✓On stable dose of oral oxybutynin before participation
Key exclusion· 2
  • ✕Treatable conditions other than neurogenic bladder dysfunction that may cause urinary incontinence or urgency
  • ✕Any medical condition that precludes participation or confounds study outcome

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00224016
NCT00224016Phase 4Completed
CompareCT.gov

A Multi-Center, Open-Label (OL), Active-Controlled, Dose-Titration Study Evaluating the Safety, Efficacy and PK of Oxybutynin Transdermal Systems in the Treatment of Detrusor Overactivity in Pediatric Patients

Watson Pharmaceuticals·interventional·Posted Sep 22, 2005·Updated Feb 9, 2012

In Brief

A Phase 4 clinical trial evaluating Oxybutynin for Detrusor Hyperreflexia. Completed, enrolled 57 participants across 23 sites.

Detailed Summary

This study will evaluate the safety and effectiveness of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in children who have a neurological condition (e.g. spina bifida) that contributes to their overactive bladder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDetrusor Hyperreflexia
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartDec 1, 2004
Primary CompletionApr 1, 2007
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.8 years ago

Interventions

Oxybutynindrug

1.3, 2.6, 3.9 mg/day transdermal

Oxybutynindrug

5 to 15 mg/day immediate release or extended release tablets, or syrup