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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")
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 4 and week 8 (both had to meet criterion for the subject to be considered a "responder")
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")
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 • NCT0391810917%
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
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