A Randomized, Double-blind, Placebo-controlled Phase 2 Study of OTO-313 Given as a Single Intratympanic Injection in Subjects With Unilateral Subjective Tinnitus
Who is this study for? Adult patients with tinnitus
What treatments are being studied? OTO-313
Status: Completed
Location: See all (48) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Central California Clinical Research
Fresno
Breathe Clear Institute
Torrance
Colorado
University of Colorado, Department of Otolaryngology
Aurora
Colorado ENT & Allergy
Colorado Springs
Florida
ENT and Allergy Associates of FL
Boynton Beach
ENT and Allergy Associates of Florida, LLC
Delray Beach
Research Centers of America
Hollywood
ENT and Allergy Associates of Florida, LLC
Plantation
ENT and Allergy Associates of Florida, LLC
Port Saint Lucie
Ear Research Foundation
Sarasota
Illinois
ChicagoENT
Chicago
Rush University Medical Center
Chicago
Kentucky
Advanced ENT and Allergy, PLLC
Louisville
Kentuckian Ear, Nose & Throat
Louisville
Louisiana
Tandem Clinical Research
Marrero
Missouri
Center for Specialized Medicine, Department of Otolaryngology-Head and Neck Surgery
Saint Louis
North Carolina
Charlotte Eye Ear Nose & Throat Associates, P.A.
Matthews
Piedmont Ear, Nose & Throat Associates, PA
Winston-salem
New Hampshire
Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital
Lebanon
New York
Dent Neurosciences Research Center
Amherst
Ohio
UC Health Otolaryngology-Head and Neck Surgery
Cincinnati
South Carolina
Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina
Charleston
Carolina Ear, Nose & Throat Clinic/CENTRI Inc.
Orangeburg
Spartanburg/Greer ENT & Allergy
Spartanburg
Tennessee
Vanderbilt University Medical Center
Nashville
Texas
Fort Worth ENT
Fort Worth
ENT Associates of Texas
Mckinney
Alamo ENT Associates
San Antonio
Utah
Chrysalis Clinical Research
Saint George
Virginia
Eastern Virginia Medical School Department of Otolatyngology
Norfolk
Advanced Otolaryngology, P.C. DBA Richmond ENT
Richmond
Other Locations
Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden
HNO - Praxis Göttingen
Göttingen
HNO Praxis am Necker
Heidelberg
HNO-Gemeinschaftspraxis
Heidelberg
Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital
Jena
HNO Praxis - Marianne Grohe
Köln
Universitätsklinikum Mannheim Klinik für Otorhinolaryngologie, Kopf- und Halschirurgie
Mannheim
Klinikum der Universitaet Muenchen
Muenchen
Poland
Centrum Medyczne Kwiatowa
Bydgoszcz
Centrum Medyczne PROMED
Kraków
Centrum Medyczne ZDROWA
Kraków
MT Medic Specjalistyczna Pralctyka Lekarska Tomasz Stapiński
Krosno
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham
NHS Tayside
Dundee
University Hospitals of Leicester NHS Trust
Leicester
Norfolk and Norwich University Hospitals NHS Trust
Norwich
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield
Time Frame
Start Date: 2021-03-22
Completion Date: 2022-06-30
Participants
Target number of participants: 153
Treatments
Experimental: OTO-313
Placebo_comparator: Placebo
Authors
Tomasz Stapiński, Steven E Davis, Joshua P Light, Peter Volsky, Jonathan Moss, John McIntyre, Lixin Zhang, Bryan M Davis, Mark Widick, Sean Wise, Brent Lanier, Erik D. Steiniger, Dale Ehmer, Craig Shapiro, Elias Michaelides, Adil Fatakia, John F Ansley, Ravi Samy, G. Paul Doxey, Kenneth S Maxwell, Adam J Levy, Stephen Cass, Peter Monksfield, Marcus Neudert, Orlando Guntinas-Lichius, John Phillips, Peter Rea, Patrick Spielmann, Curtis D Johnson, Jeffrey Rosenbloom, John T Lanza, Michael Armstrong, Angela Schell, Jennifer L. Spiegel
Related Therapeutic Areas
Sponsors
Leads: Otonomy, Inc.