A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2b Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease

Trial Profile

A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2b Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease

Completed
Phase of Trial: Phase II

Latest Information Update: 01 Dec 2016

At a glance

  • Drugs Dexamethasone (Primary)
  • Indications Meniere's disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Otonomy
  • Most Recent Events

    • 10 Nov 2015 According to an Otonomy Inc., media release, design of the 2 phase III studies (in Europe and USA respectively) was finalized based on the data from this study and a successful End-of-phase 2 meeting with FDA.
    • 24 Sep 2015 According to an Otonomy Inc., media release, the results from this trial will be presented at the 2015 American Academy of Otolaryngology - Head and Neck Surgery Foundation.
    • 21 May 2015 According to Otonomy media release, the trial achieved statistical significance for secondary vertigo endpoints based on which the company intends to initiate phase III trials.
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