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
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
- 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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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History