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OTO-313 in Subjects With Subjective Tinnitus

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ClinicalTrials.gov Identifier: NCT03918109
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : October 4, 2019
Sponsor:
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)
Estimated Enrollment : 58 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
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 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



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03918109


Contacts
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Contact: Clinical Study Manager otonomyclinicaltrials@otonomy.com

Locations
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United States, California
House Clinic Recruiting
Los Angeles, California, United States, 90057
Contact: Shanel Hill       shill@hei.org   
California Head & Neck Specialists Recruiting
San Diego, California, United States, 92121
Contact: Tricia Doughty    858-909-0770    tricia.doughty@calhns.com   
United States, Colorado
Colorado ENT and Allergy Recruiting
Colorado Springs, Colorado, United States, 80909
Contact: Deborah Bothwell    719-867-7810    dbothwell@coloradoent.com   
United States, Florida
Silverstein Institute/Ear Research Foundation Recruiting
Sarasota, Florida, United States, 34239
Contact: Dishank Patel    941-556-4264    dpatel@earrf.org   
United States, Illinois
ChicagoENT Recruiting
Chicago, Illinois, United States, 60657
Contact: Ninos J Joseph    773-289-1823    njoseph@chicagoent.com   
United States, Kentucky
Advanced ENT and Allergy Recruiting
Louisville, Kentucky, United States, 40207
Contact: Ellie Fridell    502-213-3858 ext 1185    Efridell@advancedentandallergy.com   
United States, Louisiana
Tandem Clinical Research, LLC Recruiting
Marrero, Louisiana, United States, 70072
Contact: Tammy Johnson    504-934-8424    tjohnson@tandemclinicalresearch.com   
United States, New Jersey
Summit Medical Group Recruiting
Berkeley Heights, New Jersey, United States, 10882
Contact: Kelly Ritter       kritter@smgnj.com   
United States, New York
Dent Neurosciences Research Center Recruiting
Amherst, New York, United States, 14226
Contact: Jennifer Cox, PhD    716-250-7002    jcox@dentinstitute.com   
Northwell Health, Hearing & Speech Center Recruiting
New Hyde Park, New York, United States, 11042
Contact: Ginny Mullooly    718-470-7974    gmullool@northwell.edu   
Northwell Health at ENT and Allergy Associates Recruiting
White Plains, New York, United States, 10605
Contact    845-562-5941      
United States, North Carolina
Charlotte Eye Ear Nose & Throat Associates Recruiting
Charlotte, North Carolina, United States, 28210
Piedmont Ear, Nose, and Throat Associates Recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Texas
Worldwide Clinical Trials Recruiting
San Antonio, Texas, United States, 78217
Contact: Andrea Velasquez       andrea.velasquez@worldwide.com   
United States, Utah
Chrysalis Clinical Research Recruiting
Saint George, Utah, United States, 84790
Contact: Susan Bilanzich    435-656-1704    susanb@sgccr.com   
United States, West Virginia
WVU Medicine Recruiting
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Otonomy, Inc.

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Responsible Party: Otonomy, Inc.
ClinicalTrials.gov Identifier: NCT03918109     History of Changes
Other Study ID Numbers: 313-201901
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
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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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Gacyclidine
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents