OTO-313 in Subjects With Unilateral Subjective Tinnitus
NCT ID: NCT04829214
Last Updated: 2023-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
153 participants
INTERVENTIONAL
2021-03-22
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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OTO-313
OTO-313
Single intratympanic injection
Placebo
Placebo
Single intratympanic injection
Interventions
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OTO-313
Single intratympanic injection
Placebo
Single intratympanic injection
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Otonomy, Inc.
INDUSTRY
Responsible Party
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Locations
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Central California Clinical Research
Fresno, California, United States
Breathe Clear Institute
Torrance, California, United States
University of Colorado, Department of Otolaryngology
Aurora, Colorado, United States
Colorado ENT & Allergy
Colorado Springs, Colorado, United States
ENT and Allergy Associates of FL
Boynton Beach, Florida, United States
ENT and Allergy Associates of Florida, LLC
Delray Beach, Florida, United States
Research Centers of America
Hollywood, Florida, United States
ENT and Allergy Associates of Florida, LLC
Plantation, Florida, United States
ENT and Allergy Associates of Florida, LLC
Port Saint Lucie, Florida, United States
Ear Research Foundation
Sarasota, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
ChicagoENT
Chicago, Illinois, United States
Kentuckian Ear, Nose & Throat
Louisville, Kentucky, United States
Advanced ENT and Allergy, PLLC
Louisville, Kentucky, United States
Tandem Clinical Research
Marrero, Louisiana, United States
Center for Specialized Medicine, Department of Otolaryngology-Head and Neck Surgery
St Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital
Lebanon, New Hampshire, United States
Dent Neurosciences Research Center
Amherst, New York, United States
Charlotte Eye Ear Nose & Throat Associates, P.A.
Matthews, North Carolina, United States
Piedmont Ear, Nose & Throat Associates, PA
Winston-Salem, North Carolina, United States
UC Health Otolaryngology-Head and Neck Surgery
Cincinnati, Ohio, United States
Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina
Charleston, South Carolina, United States
Carolina Ear, Nose & Throat Clinic/CENTRI Inc.
Orangeburg, South Carolina, United States
Spartanburg/Greer ENT & Allergy
Spartanburg, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Fort Worth ENT
Fort Worth, Texas, United States
ENT Associates of Texas
McKinney, Texas, United States
Alamo ENT Associates
San Antonio, Texas, United States
Chrysalis Clinical Research
St. George, Utah, United States
Eastern Virginia Medical School Department of Otolatyngology
Norfolk, Virginia, United States
Advanced Otolaryngology, P.C. DBA Richmond ENT
Richmond, Virginia, United States
HNO Praxis - Marianne Grohe
Cologne, , Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
HNO - Praxis Göttingen
Göttingen, , Germany
HNO Praxis am Necker
Heidelberg, , Germany
HNO-Gemeinschaftspraxis
Heidelberg, , Germany
Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital
Jena, , Germany
Universitätsklinikum Mannheim Klinik für Otorhinolaryngologie, Kopf- und Halschirurgie
Mannheim, , Germany
Klinikum der Universitaet Muenchen
München, , Germany
Centrum Medyczne Kwiatowa
Bydgoszcz, , Poland
Centrum Medyczne ZDROWA
Krakow, , Poland
Centrum Medyczne PROMED
Krakow, , Poland
MT Medic Specjalistyczna Pralctyka Lekarska Tomasz Stapiński
Krosno, , Poland
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
NHS Tayside
Dundee, , United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, , United Kingdom
Norfolk and Norwich University Hospitals NHS Trust
Norwich, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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OTO-313-201
Identifier Type: -
Identifier Source: org_study_id
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