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

W

Watson Pharmaceuticals

Status and phase

Completed
Phase 4

Conditions

Detrusor Hyperreflexia

Treatments

Drug: Oxybutynin

Study type

Interventional

Funder types

Industry

Identifiers

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)

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

Trial contacts and locations

23

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Data sourced from clinicaltrials.gov

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