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A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2 STUDY OF OTO-313 GIVEN AS A SINGLE INTRATYMPANIC INJECTION IN SUBJECTS WITH UNILATERAL SUBJECTIVE TINNITUS

Study category: Ear, Nose, and Throat

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Description

If you are to take part in this study, you would be able to come to the clinic for 6 visits which lasts about 110 days. Visit 1 (Screening) and 2 (Baseline) will have about the same procedures done: 1. We will ask about your demographics, medical history, and current medications and check you vital signs 2. We will ask you some questionnaires 3. We will do a blood draw and take your urine for lab tests to check the safety of the medication 4. The Provider will examine your ears and an Audiologist will check your hearing 5. You will receive an electronic Daily Diary which you will need to complete every night of the trial 6. During Visit 2, if you qualify, you will be randomized in to the placebo or the investigational product group. This is a completely blind trial. The Providers, Audiologists, Clinical Research Staff and yourself won't know which group you are in. You will receive the injection. For Visits 3 – 5: 1. We will ask you about your current medications, changes to your health, and take your vital signs 2. We will ask you some questionnaires 3. The Provider will examine your ears and an Audiologist will check your hearing For Visit 6: 1. We will ask you about your current medications, changes to your health, and take your vital signs 2. We will ask you some questionnaires 3. We will do a blood draw and take your urine for lab tests to check the safety of the medication 4. The Provider will examine your ears and an Audiologist will check your hearing

Details
Age

Adult

Eligibility

Inclusion Criteria 1. Subject is a male or female aged 18 to 75 years 2. Subject has tinnitus in one ear only 3. Subject’s tinnitus is between 2 months and 12 months 4. Subject is able to use the daily diary every night of the study 5. Female and Male subjects of childbearing potential [i.e., not surgically sterile and/or not post-menopausal] must use contraception or abstinence. 6. Subject is willing to comply with the protocol and attend all study visits. Exclusion Criteria 1. Only stable tinnitus treatments (i.e., initiated at least 1 month prior to Screening) are allowed during the study and no new treatments should be introduced during the course of the Study. 2. Please check with study staff about the medications you are taking. 3. Subject is pregnant, lactating, or undergoing fertility treatment. 4. Subject has a history of any use of intratympanic gentamicin in the affected ear. 5. Subject has received systemic or intratympanic steroids (including dexamethasone) within 6 weeks prior to the Screening visit. More Inclusion/Exclusion criteria apply

Type of Study

Treatment

Location

University of Colorado Hospital

Principal Investigator
Stephen Cass,  MD, MPH/MSPH

Stephen Cass, MD, MPH/MSPH

Study ID

Protocol Number: 21-3418

More information available at ClinicalTrials.gov: NCT04829214

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