Intratympanic Sustained-Exposure Dexamethasone Thermosensitive Gel for Symptoms of Meniere's Disease: Randomized Phase 2b Safety and Efficacy Trial.

ABSTRACT:

Objective

To evaluate safety and efficacy of a single intratympanic injection of OTO-104, sustained-exposure dexamethasone, in patients with unilateral Ménière's disease.

Study design

Randomized, double-blind, placebo-controlled, Phase 2b study over 5 months.

Setting

Fifty-two academic and community otolaryngology centers.

Patients

One hundred fifty four patients (77 per group) aged 18 to 85 years inclusive.

Intervention

Single intratympanic injection of OTO-104 (12 mg dexamethasone) or placebo.

Main outcome measures

Efficacy (vertigo) and safety (adverse events, otoscopy, audiometry, tympanometry).

Results

Primary endpoint (change from baseline in vertigo rate at Month 3) was not statistically significant (placebo [-43%], OTO-104 [-61%], P

SUBMITTER: Lambert PR 

PROVIDER: S-EPMC5414596 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature