Overview

Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence

Status:
Completed
Trial end date:
2010-11-01
Target enrollment:
Participant gender:
Summary
The primary objective of the double-blind phase of the study is to compare the effects of two doses of oxybutynin gel to placebo gel. The objective of the open-label extension is to evaluate the extended safety and skin-irritation profile of topically administered oxybutynin gel. The hypothesis is that topically administered oxybutynin gel will decrease (compared to placebo) the number of incontinence episodes per week, average daily urinary frequency, and urinary urgency; increase average urinary void volume; and improve patient quality of life.
Phase:
Phase 3
Details
Lead Sponsor:
Antares Pharma Inc.
Treatments:
Mandelic Acids
Oxybutynin