- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04829214
OTO-313 in Subjects With Unilateral Subjective Tinnitus
December 13, 2022 updated by: Otonomy, Inc.
A Randomized, Double-blind, Placebo-controlled Phase 2 Study of OTO-313 Given as a Single Intratympanic Injection in Subjects With Unilateral Subjective Tinnitus
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
153
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Dresden, Germany, 01307
- Universitätsklinikum Carl Gustav Carus Dresden
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Göttingen, Germany, 37073
- HNO - Praxis Göttingen
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Heidelberg, Germany, 69120
- HNO Praxis am Necker
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Heidelberg, Germany, 69126
- HNO-Gemeinschaftspraxis
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Jena, Germany, 07747
- Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital
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Köln, Germany, 51061
- HNO Praxis - Marianne Grohe
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Mannheim, Germany, 68167
- Universitätsklinikum Mannheim Klinik für Otorhinolaryngologie, Kopf- und Halschirurgie
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Muenchen, Germany, 81377
- Klinikum der Universitaet Muenchen
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Bydgoszcz, Poland, 85-047
- Centrum Medyczne Kwiatowa
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Kraków, Poland, 31-216
- Centrum Medyczne ZDROWA
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Kraków, Poland, 31-411
- Centrum Medyczne PROMED
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Krosno, Poland, 38-400
- MT Medic Specjalistyczna Pralctyka Lekarska Tomasz Stapiński
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Birmingham, United Kingdom, B15 2TH
- University Hospitals Birmingham NHS Foundation Trust
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Dundee, United Kingdom, DD1 9SY
- NHS Tayside
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Leicester, United Kingdom, LE1 5WW
- University Hospitals of Leicester NHS Trust
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Norwich, United Kingdom, NR47UY
- Norfolk and Norwich University Hospitals NHS Trust
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Sheffield, United Kingdom, S10 2JF
- Sheffield Teaching Hospitals NHS Foundation Trust
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California
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Fresno, California, United States, 93720
- Central California Clinical Research
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Torrance, California, United States, 90503
- Breathe Clear Institute
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado, Department of Otolaryngology
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Colorado Springs, Colorado, United States, 80923
- Colorado ENT & Allergy
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Florida
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Boynton Beach, Florida, United States, 33426
- ENT and Allergy Associates of FL
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Delray Beach, Florida, United States, 33484
- ENT and Allergy Associates of Florida, LLC
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Hollywood, Florida, United States, 33024
- Research Centers of America
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Plantation, Florida, United States, 33324
- ENT and Allergy Associates of Florida, LLC
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Port Saint Lucie, Florida, United States, 34952
- ENT and Allergy Associates of Florida, LLC
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Sarasota, Florida, United States, 34239
- Ear Research Foundation
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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Chicago, Illinois, United States, 60657
- ChicagoENT
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Kentucky
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Louisville, Kentucky, United States, 40205
- Kentuckian Ear, Nose & Throat
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Louisville, Kentucky, United States, 40220
- Advanced ENT and Allergy, PLLC
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Louisiana
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Marrero, Louisiana, United States, 70072
- Tandem Clinical Research
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Missouri
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Saint Louis, Missouri, United States, 63104
- Center for Specialized Medicine, Department of Otolaryngology-Head and Neck Surgery
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital
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New York
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Amherst, New York, United States, 14226
- Dent Neurosciences Research Center
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North Carolina
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Matthews, North Carolina, United States, 28105
- Charlotte Eye Ear Nose & Throat Associates, P.A.
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Winston-Salem, North Carolina, United States, 27103
- Piedmont Ear, Nose & Throat Associates, PA
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Ohio
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Cincinnati, Ohio, United States, 45267
- UC Health Otolaryngology-Head and Neck Surgery
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South Carolina
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Charleston, South Carolina, United States, 29425
- Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina
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Orangeburg, South Carolina, United States, 29118
- Carolina Ear, Nose & Throat Clinic/CENTRI Inc.
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Spartanburg, South Carolina, United States, 29303
- Spartanburg/Greer ENT & Allergy
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Tennessee
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Nashville, Tennessee, United States, 37232-8605
- Vanderbilt University Medical Center
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Texas
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Fort Worth, Texas, United States, 76109
- Fort Worth ENT
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McKinney, Texas, United States, 75070
- ENT Associates of Texas
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San Antonio, Texas, United States, 45227
- Alamo ENT Associates
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Utah
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Saint George, Utah, United States, 84790
- Chrysalis Clinical Research
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Virginia
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Norfolk, Virginia, United States, 23507
- Eastern Virginia Medical School Department of Otolatyngology
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Richmond, Virginia, United States, 23235
- Advanced Otolaryngology, P.C. DBA Richmond ENT
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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Single intratympanic injection
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Experimental: OTO-313
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Single intratympanic injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Tinnitus Functional Index (TFI) Responders at Weeks 4 and at Week 8
Time Frame: Week 4 and Week 8 (both had to meet criterion for the subject to be considered a "responder")
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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.
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Week 4 and Week 8 (both had to meet criterion for the subject to be considered a "responder")
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Daily Tinnitus Loudness at Week 8
Time Frame: The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8.
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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.
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The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8.
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Change From Baseline in Daily Tinnitus Annoyance at Week 8
Time Frame: The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8
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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.
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The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8
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Patient Global Impression of Change at Week 8
Time Frame: Week 8 reported here
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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.
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Week 8 reported here
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Otoscopic Examinations - Presence of Perforation in the Treated Ear at Week 16 (Final Visit)
Time Frame: After dosing (Baseline) up to end of study (16 Weeks)
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Ear examinations were done at every visit.
One of the important safety endpoints is an observation of a perforation in the ear drum that did not heal properly after the injection.
Reported here are the Week 16 (final visit) results.
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After dosing (Baseline) up to end of study (16 Weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 22, 2021
Primary Completion (Actual)
June 30, 2022
Study Completion (Actual)
June 30, 2022
Study Registration Dates
First Submitted
March 29, 2021
First Submitted That Met QC Criteria
March 31, 2021
First Posted (Actual)
April 2, 2021
Study Record Updates
Last Update Posted (Estimate)
January 6, 2023
Last Update Submitted That Met QC Criteria
December 13, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OTO-313-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Subjective Tinnitus
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Clinical Trials on OTO-313
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Otonomy, Inc.Completed