CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 43 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.

Search/NCT03918109
NCT03918109Phase 2Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled Phase 1/2 Study of OTO-313 Given as a Single Intratympanic Injection in Subjects With Subjective Tinnitus

Otonomy, Inc.·interventional·Posted Apr 17, 2019·Updated Dec 23, 2022

In Brief

A Phase 2 clinical trial evaluating OTO-313 and Placebo for Tinnitus, Subjective. Completed, enrolled 43 participants across 16 sites.

Detailed Summary

The purpose of this study is to evaluate the safety, tolerability, plasma pharmacokinetics (PK), and exploratory efficacy of OTO-313 administered as an intratympanic injection for the treatment of subjective tinnitus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTinnitus, Subjective
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 17, 2019
Enrollment StartApr 4, 2019
Primary CompletionMay 29, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.2 years ago

Interventions

OTO-313drug

single intratympanic injection of gacyclidine

Placebodrug

single intratympanic injection of placebo