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Your journey
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More info
You can access this
clinical trial
if you have
Urge Urinary Incontinence or Urinary Frequency
and you are
over 18
years old
3
This is a trial in the final phase before the treatment is released on the market.
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The purpose

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.

Provided treatments

  • Drug: Oxybutynin
  • Drug: Placebo
Tris trial is registered with FDA with number: NCT00909181. The sponsor of the trial is Antares Pharma Inc. and it is looking for 626 volunteers for the current phase.
Official trial title:
A Double-Blind, Randomized, Parallel, Placebo-Controlled, Multicenter Study Evaluating the Effect of Treatment With Topically Administered Oxybutynin Gel in Patients With Urinary Frequency, and Urge and Mixed Urinary Incontinence With a Predominance of Urge Incontinence Episodes With an Open-Label Extension