At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 153 enrolled
Drug / intervention
OTO-313 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled Phase 2 Study of OTO-313 Given as a Single Intratympanic Injection in Subjects With Unilateral Subjective Tinnitus
In Brief
A Phase 2 clinical trial evaluating OTO-313 and Placebo for Subjective Tinnitus. Completed, enrolled 153 participants across 48 sites in 4 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSubjective Tinnitus
CountriesGermany, Poland, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20222023202420252026
Enrollment StartMar 2021
First PostedApr 2021
Primary CompletionJun 2022
TodayJul 2026
First PostedApr 2, 2021
Enrollment StartMar 22, 2021
Primary CompletionJun 30, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 5.3 years ago
Interventions
OTO-313drug
Single intratympanic injection
Placebodrug
Single intratympanic injection