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
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 06 Aug 2020
Price :
$35
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At a glance
- Drugs Dexamethasone (Primary)
- Indications Meniere's disease
- Focus Registrational; Therapeutic Use
- Sponsors Otonomy [CEASED]
- 04 Aug 2020 According to an Otonomy media release, the Negative Binomial model provides the best fit of the OTIVIDEX clinical data based on this and AVERTS-2 trial and integrated dataset from both trials.
- 06 Jul 2020 Ad hoc analysis (n=97) results are presented in an Otonomy media release.
- 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.