Clinical Trial: Phase 3 Study of OTO-201 in Acute Otitis Externa

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, Phase 3 Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Externa

Brief Summary: This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external auditory canal of the affected ear(s).

Detailed Summary:
Sponsor: Otonomy, Inc.

Current Primary Outcome: Clinical cure assessed by otoscopic examination [ Time Frame: Up to Day 8 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Safety as assessed by adverse events [ Time Frame: Up to 1 month ]

Evaluation of adverse events


Original Secondary Outcome: Same as current

Information By: Otonomy, Inc.

Dates:
Date Received: June 13, 2016
Date Started: June 2016
Date Completion:
Last Updated: December 14, 2016
Last Verified: December 2016