drugset

drugset / Trial / NCT02612337

Study of OTO-104 in Subjects With Unilateral Meniere's Disease

NCT02612337 ↗

Phase 3 Completed 166 enrolled Otonomy, Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.

Timeline

Start: 2015-10-27
Primary completion: 2017-07-18
Completion: 2017-07-18

Outcome

Missed primary endpoint

registry analysis (superiority test); OTO-104 (Full Analysis Set) vs Placebo (Full Analysis Set); p = 0.623 NCT02612337 ↗

Publications

Phillips J, Mikulec AA, Robinson JM, Skarinsky D, Anderson JJ. Efficacy of Intratympanic OTO-104 for the Treatment of Meniere's Disease: The Outcome of Three Randomized, Double-Blind, Placebo-Controlled Studies. Otol Neurotol. 2023 Jul 1;44(6):584-592. doi: 10.1097/MAO.0000000000003886. Epub 2023 Apr 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexamethasone	Small molecule	12 mg	Other

Indications