Status:
COMPLETED
OTO-313 in Subjects With Unilateral Subjective Tinnitus
Lead Sponsor:
Otonomy, Inc.
Conditions:
Subjective Tinnitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the efficacy of OTO-313 in subjects with unilateral tinnitus and to determine the safety and tolerability of OTO-313 in subjects with unilateral tinnitus.
Eligibility Criteria
Inclusion
- Subject has early-onset subjective unilateral tinnitus that is persistent (consistently aware of their tinnitus throughout much of the waking day).
- Subject is able to use the 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.
Exclusion
- Subject has pulsatile tinnitus, temporomandibular joint disease (TMJ) associated with tinnitus perception, tinnitus resulting from traumatic head or neck injury, or tinnitus resulting from a tumor or stroke.
- Subject is pregnant, lactating, or undergoing fertility treatment.
- Subject has other clinically significant illness, medical condition or medical history at Screening or Baseline that, in the Investigator's opinion, would likely reduce the safety of study participation or compliance with study procedures.
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT04829214
Start Date
March 22 2021
End Date
June 30 2022
Last Update
January 6 2023
Active Locations (48)
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1
Central California Clinical Research
Fresno, California, United States, 93720
2
Breathe Clear Institute
Torrance, California, United States, 90503
3
University of Colorado, Department of Otolaryngology
Aurora, Colorado, United States, 80045
4
Colorado ENT & Allergy
Colorado Springs, Colorado, United States, 80923