OTO-313 in Subjects With Unilateral Subjective Tinnitus
- Registration Number
- NCT04829214
- Lead Sponsor
- Otonomy, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - OTO-313 OTO-313 -
- Primary Outcome Measures
Name Time Method Percentage of Tinnitus Functional Index (TFI) Responders at Weeks 4 and at Week 8 Week 4 and Week 8 (both had to meet criterion for the subject to be considered a "responder") The TFI is a validated, 25-item questionnaire; index score from 0 to 100; higher scores indicate a greater problem with tinnitus. A responder is considered as any subject with at least a 13-point improvement from Baseline on the (TFI). This responder analysis required both Week 4 and Week 8 to have a 13-point improvement from Baseline.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Daily Tinnitus Loudness at Week 8 The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8. Numerical rating scale (NRS) from 0 (No Tinnitus) to 10 (Extremely Loud Tinnitus) collected every day. Post-baseline weekly NRS scores will be calculated as the average score of all recorded diary entries within each study week.
Change From Baseline in Daily Tinnitus Annoyance at Week 8 The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8 Numerical rating scale from 0 (Not Annoying) to 10 (Extremely Annoying) collected every day. Post-baseline weekly NRS scores will be calculated as the average score of all recorded diary entries within each study week.
Patient Global Impression of Change at Week 8 Week 8 reported here Change in overall tinnitus status as perceived by the subject as assessed at the Week 8 visit. Subjects were asked, "Since the beginning of the clinical study, how would you rate your tinnitus?" and had the choice to answer from very much worse (-3) to very much improved (3). The mean change from baseline at Week 8 is reported here.
Trial Locations
- Locations (46)
ChicagoENT
๐บ๐ธChicago, Illinois, United States
Centrum Medyczne ZDROWA
๐ต๐ฑKrakรณw, Poland
Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital
๐บ๐ธLebanon, New Hampshire, United States
NHS Tayside
๐ฌ๐งDundee, United Kingdom
Carolina Ear, Nose & Throat Clinic/CENTRI Inc.
๐บ๐ธOrangeburg, South Carolina, United States
Central California Clinical Research
๐บ๐ธFresno, California, United States
Breathe Clear Institute
๐บ๐ธTorrance, California, United States
Tandem Clinical Research
๐บ๐ธMarrero, Louisiana, United States
Ear Research Foundation
๐บ๐ธSarasota, Florida, United States
Center for Specialized Medicine, Department of Otolaryngology-Head and Neck Surgery
๐บ๐ธSaint Louis, Missouri, United States
UC Health Otolaryngology-Head and Neck Surgery
๐บ๐ธCincinnati, Ohio, United States
Charlotte Eye Ear Nose & Throat Associates, P.A.
๐บ๐ธMatthews, North Carolina, United States
Spartanburg/Greer ENT & Allergy
๐บ๐ธSpartanburg, South Carolina, United States
Alamo ENT Associates
๐บ๐ธSan Antonio, Texas, United States
Chrysalis Clinical Research
๐บ๐ธSaint George, Utah, United States
Vanderbilt University Medical Center
๐บ๐ธNashville, Tennessee, United States
HNO Praxis - Marianne Grohe
๐ฉ๐ชKรถln, Germany
Centrum Medyczne Kwiatowa
๐ต๐ฑBydgoszcz, Poland
HNO Praxis am Necker
๐ฉ๐ชHeidelberg, Germany
HNO-Gemeinschaftspraxis
๐ฉ๐ชHeidelberg, Germany
Universitรคtsklinikum Mannheim Klinik fรผr Otorhinolaryngologie, Kopf- und Halschirurgie
๐ฉ๐ชMannheim, Germany
Klinikum der Universitaet Muenchen
๐ฉ๐ชMuenchen, Germany
Centrum Medyczne PROMED
๐ต๐ฑKrakรณw, Poland
University Hospitals of Leicester NHS Trust
๐ฌ๐งLeicester, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
๐ฌ๐งBirmingham, United Kingdom
Norfolk and Norwich University Hospitals NHS Trust
๐ฌ๐งNorwich, United Kingdom
Universitรคtsklinikum Carl Gustav Carus Dresden
๐ฉ๐ชDresden, Germany
HNO - Praxis Gรถttingen
๐ฉ๐ชGรถttingen, Germany
Rush University Medical Center
๐บ๐ธChicago, Illinois, United States
Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital
๐ฉ๐ชJena, Germany
Colorado ENT & Allergy
๐บ๐ธColorado Springs, Colorado, United States
ENT and Allergy Associates of FL
๐บ๐ธBoynton Beach, Florida, United States
ENT and Allergy Associates of Florida, LLC
๐บ๐ธPort Saint Lucie, Florida, United States
Dent Neurosciences Research Center
๐บ๐ธAmherst, New York, United States
Research Centers of America
๐บ๐ธHollywood, Florida, United States
Fort Worth ENT
๐บ๐ธFort Worth, Texas, United States
ENT Associates of Texas
๐บ๐ธMcKinney, Texas, United States
Eastern Virginia Medical School Department of Otolatyngology
๐บ๐ธNorfolk, Virginia, United States
Advanced Otolaryngology, P.C. DBA Richmond ENT
๐บ๐ธRichmond, Virginia, United States
MT Medic Specjalistyczna Pralctyka Lekarska Tomasz Stapiลski
๐ต๐ฑKrosno, Poland
Sheffield Teaching Hospitals NHS Foundation Trust
๐ฌ๐งSheffield, United Kingdom
Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina
๐บ๐ธCharleston, South Carolina, United States
Piedmont Ear, Nose & Throat Associates, PA
๐บ๐ธWinston-Salem, North Carolina, United States
University of Colorado, Department of Otolaryngology
๐บ๐ธAurora, Colorado, United States
Kentuckian Ear, Nose & Throat
๐บ๐ธLouisville, Kentucky, United States
Advanced ENT and Allergy, PLLC
๐บ๐ธLouisville, Kentucky, United States