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OTO-313 in Subjects With Subjective Tinnitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03918109
Recruitment Status : Completed
First Posted : April 17, 2019
Last Update Posted : June 17, 2020
Information provided by (Responsible Party):
Otonomy, Inc.

Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, plasma pharmacokinetics (PK), and exploratory efficacy of OTO-313 administered as an intratympanic injection for the treatment of subjective tinnitus.

Condition or disease Intervention/treatment Phase
Tinnitus, Subjective Drug: OTO-313 Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, placebo-controlled, multicenter
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Phase 1/2 Study of OTO-313 Given as a Single Intratympanic Injection in Subjects With Subjective Tinnitus
Actual Study Start Date : April 4, 2019
Actual Primary Completion Date : May 29, 2020
Actual Study Completion Date : May 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Experimental: OTO-313 Drug: OTO-313
single intratympanic injection of gacyclidine

Placebo Comparator: Placebo Drug: Placebo
single intratympanic injection of placebo

Primary Outcome Measures :
  1. Treatment Emergent Adverse Events [ Time Frame: Reported or observed during or after dosing (Day 1) up to end of study (Day 57 - 8 weeks after dosing) ]
    An adverse event (AE) is any unfavorable and unintended diagnosis, symptom, sign, syndrome or disease which occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen.

  2. Audiometry [ Time Frame: After dosing (Day 1) up to end of study (Day 57 - 8 weeks after dosing) ]
    Clinically significant adverse change from Baseline

  3. Otoscopic Examinations [ Time Frame: After dosing (Day 1) up to end of study (Day 57 - 8 weeks after dosing) ]
    Clinically significant adverse change from Baseline

Secondary Outcome Measures :
  1. Plasma Pharmacokinetics (PK) [ Time Frame: Specified timepoints for the first 24 hours and 1 week later ]
    Concentrations of gacyclidine in plasma

Other Outcome Measures:
  1. Tinnitus Functional Index [ Time Frame: At screening, baseline (Day 1), Day 15, Day 29, Day 57 ]
    Validated, 25-item questionnaire; index score from 0 to 100; higher scores indicate greater problem with tinnitus

  2. Daily Tinnitus Annoyance [ Time Frame: Start of Lead-in (Day -14) to end of study (Day 57) ]
    Numerical rating scale from 0 (Not Annoying) to 10 (Extremely Annoying) collected every day

  3. Daily Tinnitus Loudness [ Time Frame: Start of Lead-in (Day -14) to end of study (Day 57) ]
    Numerical rating scale from 0 (No Tinnitus) to 10 (Extremely Loud Tinnitus) collected every

  4. Patient Global Impression of Change [ Time Frame: Day 8, Day 15, Day 29, Day 57 ]
    Change in overall tinnitus status as perceived by the subject

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject has subjective unilateral tinnitus and is consistently aware of their tinnitus throughout much of the waking day.
  • Subject is able to use the electronic 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, tinnitus resulting from traumatic head or neck injury, or tinnitus resulting from a tumor or stroke.
  • Subject is pregnant or lactating.
  • Subject has other clinically significant illness, medical condition or medical history at Screening or Baseline (Day 1) that, in the Investigator's opinion, would likely reduce the safety of study participation or compliance with study procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03918109

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United States, California
House Clinic
Los Angeles, California, United States, 90057
California Head & Neck Specialists
San Diego, California, United States, 92121
United States, Colorado
Colorado ENT and Allergy
Colorado Springs, Colorado, United States, 80909
United States, Florida
Silverstein Institute/Ear Research Foundation
Sarasota, Florida, United States, 34239
United States, Illinois
Chicago, Illinois, United States, 60657
United States, Kentucky
Advanced ENT and Allergy
Louisville, Kentucky, United States, 40207
United States, Louisiana
Tandem Clinical Research, LLC
Marrero, Louisiana, United States, 70072
United States, New Jersey
Summit Medical Group
Berkeley Heights, New Jersey, United States, 10882
United States, New York
Dent Neurosciences Research Center
Amherst, New York, United States, 14226
Northwell Health, Hearing & Speech Center
New Hyde Park, New York, United States, 11042
Northwell Health at ENT and Allergy Associates
White Plains, New York, United States, 10605
United States, North Carolina
Charlotte Eye Ear Nose & Throat Associates
Charlotte, North Carolina, United States, 28210
Piedmont Ear, Nose, and Throat Associates
Winston-Salem, North Carolina, United States, 27103
United States, Texas
Worldwide Clinical Trials
San Antonio, Texas, United States, 78217
United States, Utah
Chrysalis Clinical Research
Saint George, Utah, United States, 84790
United States, West Virginia
WVU Medicine
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Otonomy, Inc.
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Responsible Party: Otonomy, Inc. Identifier: NCT03918109    
Other Study ID Numbers: 313-201901
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Otonomy, Inc.:
tinnitus, intratympanic injection, gacyclidine
Additional relevant MeSH terms:
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Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases