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

NCT02717442 ↗

Phase 3 Terminated 176 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: 2016-03-21
Primary completion: 2017-08-31
Completion: 2017-09-15

Outcome

Met primary endpoint

Stopped: “Negative Efficacy Results from the recently completed Phase 3 study 104-201506”

registry analysis (superiority test); OTO-104 (Full Analysis Set -1) vs Placebo (Full Analysis Set - 1); p =0.029; Risk Ratio (RR) 0.658 (95% CI 0.453 to 0.957) NCT02717442 ↗

registry analysis (superiority test); OTO-104 (Full Analysis Set -2) vs Placebo (Full Analysis Set - 2); p =0.014; Risk Ratio (RR) 0.590 (95% CI 0.388 to 0.896) NCT02717442 ↗

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