OTO-313 in Subjects With Subjective Tinnitus

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Tinnitus, Subjective

In brief

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.

Key facts

Study ID

NCT03918109

Run by

Otonomy, Inc.

People needed

43

Starts

2019-04-04

Expected to finish

2020-05-29

Last updated by the study team

2022-12-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has subjective unilateral tinnitus and is consistently aware of their tinnitus throughout much of the waking day.
• Subject is able to use the electronic diary to complete their daily tinnitus ratings
• Subject's tinnitus is likely of cochlear origin, e.g., associated with sensorineural hearing loss; acute hearing loss from noise trauma, barotrauma, or traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear barotrauma); age-related hearing loss; resolved otitis media; ototoxic drug exposure.
• Subject is willing to comply with the protocol and attend all study visits.

You may not qualify if…

• Subject has pulsatile tinnitus, tinnitus resulting from traumatic head or neck injury, or tinnitus resulting from a tumor or stroke.
• Subject is pregnant or lactating.
• Subject has other clinically significant illness, medical condition or medical history at Screening or Baseline (Day 1) that, in the Investigator's opinion, would likely reduce the safety of study participation or compliance with study procedures.

Where it is running

• House Clinic — Los Angeles, California, United States
• California Head & Neck Specialists — San Diego, California, United States
• Colorado ENT and Allergy — Colorado Springs, Colorado, United States
• Silverstein Institute/Ear Research Foundation — Sarasota, Florida, United States
• ChicagoENT — Chicago, Illinois, United States
• Advanced ENT and Allergy — Louisville, Kentucky, United States
• Tandem Clinical Research, LLC — Marrero, Louisiana, United States
• Summit Medical Group — Berkeley Heights, New Jersey, United States
• Dent Neurosciences Research Center — Amherst, New York, United States
• Northwell Health, Hearing & Speech Center — New Hyde Park, New York, United States
• Northwell Health at ENT and Allergy Associates — White Plains, New York, United States
• Charlotte Eye Ear Nose & Throat Associates — Charlotte, North Carolina, United States
• Piedmont Ear, Nose, and Throat Associates — Winston-Salem, North Carolina, United States
• Worldwide Clinical Trials — San Antonio, Texas, United States
• Chrysalis Clinical Research — St. George, Utah, United States
• WVU Medicine — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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