Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition

Watson Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Detrusor Hyperreflexia

Treatments: Drug: Oxybutynin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00224016

O03010

Details and patient eligibility

About

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.

Full description

This study will use a multicenter, randomized, open-label, active-controlled, dose-titration, parallel group design, in approximately pediatric patients with detrusor overactivity associated with a neurological condition.

Enrollment: 57 patients

Sex: All

Ages: 6 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pediatric patient with a diagnosis of detrusor overactivity associated with a neurological condition;
• Use clean intermittent catheterization
• On stable dose of oral oxybutynin before participation

Exclusion criteria

• Have one or more treatable conditions, other than neurogenic bladder dysfunction, that may cause urinary incontinence or urgency
• Have any medical condition that precludes their participation in the study or may confound the outcome of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

Oxybutynin Transdermal System

Experimental group

Description:

Oxybutynin Transdermal System 1.3 mg/day, 2.6 mg/day, or 3.9 mg/day

Treatment:

Drug: Oxybutynin

Drug: Oxybutynin

Oral oxybutynin

Active Comparator group

Description:

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

Treatment:

Drug: Oxybutynin

Drug: Oxybutynin