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OTO-313 for Tinnitus

Phase 2
Waitlist Available
Research Sponsored by Otonomy, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4 and week 8 (both had to meet criterion for the subject to be considered a "responder")
Awards & highlights

Summary

This trial is testing OTO-313, a medication, to see if it can help people who have ringing in one ear. The study aims to determine if the medication is safe and effective for reducing or eliminating the ringing sound.

Eligible Conditions
  • Tinnitus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4 and week 8 (both had to meet criterion for the subject to be considered a "responder")
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4 and week 8 (both had to meet criterion for the subject to be considered a "responder") for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Tinnitus Functional Index (TFI) Responders at Weeks 4 and at Week 8
Secondary study objectives
Change From Baseline in Daily Tinnitus Annoyance at Week 8
Change From Baseline in Daily Tinnitus Loudness at Week 8
Patient Global Impression of Change at Week 8
Other study objectives
Otoscopic Examinations - Presence of Perforation in the Treated Ear at Week 16 (Final Visit)

Side effects data

From 2020 Phase 1 & 2 trial • 43 Patients • NCT03918109
17%
Injection Site Pain
17%
Injection Site Discomfort
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A OTO-313
Part A Placebo
Part B OTO-313
Part B Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OTO-313Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OTO-313
2019
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Otonomy, Inc.Lead Sponsor
21 Previous Clinical Trials
2,926 Total Patients Enrolled
1 Trials studying Tinnitus
43 Patients Enrolled for Tinnitus
~35 spots leftby Sep 2025
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