drugset / Trial / NCT00909181

Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence

NCT00909181

Phase 3 Completed 626 enrolled Antares Pharma Inc.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2009-03
Primary completion
2010-07
Completion
2010-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxybutynin Small molecule 56 mg Other
Subject Oxybutynin Small molecule 84 mg Other

Indications