OTO-313 in Subjects With Unilateral Subjective Tinnitus

Summary

The purpose of this study is to determine the efficacy of OTO-313 in subjects with unilateral tinnitus and to determine the safety and tolerability of OTO-313 in subjects with unilateral tinnitus.

Timeline

Start

2021-03-22

Primary completion

2022-06-30

Completion

2022-06-30

Outcome

Missed primary endpoint

registry analysis (superiority test); OTO-313 Full Analysis Set vs Placebo Full Analysis Set; p =0.385; Risk Difference (RD) -10.2 (95% CI -26 to 5); Mantel Haenszel NCT04829214 ↗

Drugs

Indications