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Completed Phase 1Phase 2 Interventional Results available

OTO-313 in Subjects With Subjective Tinnitus

ClinicalTrials.gov ID: NCT03918109

Public ClinicalTrials.gov record NCT03918109. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 5:45 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT03918109
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Otonomy, Inc.
Industry
Enrollment
43 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 4, 2019 (Actual)
Primary completion
May 29, 2020 (Actual)
Completion
May 29, 2020 (Actual)
Last update posted
Dec 23, 2022

2019 – 2020

United States locations

U.S. sites
16
U.S. states
12
U.S. cities
16
Facility City State ZIP Site status
House Clinic Los Angeles California 90057 —
California Head & Neck Specialists San Diego California 92121 —
Colorado ENT and Allergy Colorado Springs Colorado 80909 —
Silverstein Institute/Ear Research Foundation Sarasota Florida 34239 —
ChicagoENT Chicago Illinois 60657 —
Advanced ENT and Allergy Louisville Kentucky 40207 —
Tandem Clinical Research, LLC Marrero Louisiana 70072 —
Summit Medical Group Berkeley Heights New Jersey 10882 —
Dent Neurosciences Research Center Amherst New York 14226 —
Northwell Health, Hearing & Speech Center New Hyde Park New York 11042 —
Northwell Health at ENT and Allergy Associates White Plains New York 10605 —
Charlotte Eye Ear Nose & Throat Associates Charlotte North Carolina 28210 —
Piedmont Ear, Nose, and Throat Associates Winston-Salem North Carolina 27103 —
Worldwide Clinical Trials San Antonio Texas 78217 —
Chrysalis Clinical Research St. George Utah 84790 —
WVU Medicine Morgantown West Virginia 26506 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03918109, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 23, 2022 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03918109 live on ClinicalTrials.gov.

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