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
Price : $35 *
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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History