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OTO-313 in Subjects With Unilateral Subjective Tinnitus

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ClinicalTrials.gov Identifier: NCT04829214
Recruitment Status : Recruiting
First Posted : April 2, 2021
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 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 2 Study of OTO-313 Given as a Single Intratympanic Injection in Subjects With Unilateral Subjective Tinnitus
Actual Study Start Date : March 22, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : August 2022

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

Placebo Comparator: Placebo Drug: Placebo
Single intratympanic injection




Primary Outcome Measures :
  1. Change from Baseline in Tinnitus Functional Index (TFI) [ Time Frame: Week 4, Week 8 ]
    The TFI is a validated, 25-item questionnaire; index score from 0 to 100; higher scores indicate a greater problem with tinnitus


Secondary Outcome Measures :
  1. Daily Tinnitus Loudness [ Time Frame: Start of Lead-in (2 weeks before Baseline) to end of study (Week 16) ]
    Numerical rating scale from 0 (No Tinnitus) to 10 (Extremely Loud Tinnitus) collected every day

  2. Daily Tinnitus Annoyance [ Time Frame: Start of Lead-in (2 weeks before Baseline) to end of study (Week 16) ]
    Numerical rating scale from 0 (Not Annoying) to 10 (Extremely Annoying) collected every day

  3. Patient Global Impression of Change [ Time Frame: Week 4, Week 8, Week 12, Week 16 ]
    Change in overall tinnitus status as perceived by the subject


Other Outcome Measures:
  1. Treatment Emergent Adverse Events [ Time Frame: Reported or observed during or after dosing (Baseline) up to end of study (16 Weeks) ]
    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. Treatment emergent means it started during or after dosing.

  2. Audiometry [ Time Frame: Screening, after dosing (Baseline) up to end of study (16 Weeks) ]
    Hearing function - clinically significant adverse change from Baseline

  3. Otoscopic Examinations [ Time Frame: After dosing (Baseline) up to end of study (16 Weeks) ]
    Ear examination - clinically significant adverse change from Baseline



Information from the National Library of Medicine

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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 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.

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): NCT04829214


Contacts
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Contact: Clinical Study Manager otonomyclinicaltrials@otonomy.com

Locations
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United States, California
Central California Clinical Research Recruiting
Fresno, California, United States, 93720
Contact: Aimee Martinez    559-432-3303 ext 206    amartinez@ccent.com   
Principal Investigator: Brent Lanier, MD         
United States, Colorado
Colorado ENT & Allergy Recruiting
Colorado Springs, Colorado, United States, 80923
Contact: Monica Davis    719-867-7804    mdavis@coloradoent.com   
Contact    719-867-7800      
Principal Investigator: Bryan M Davis, MD         
United States, Florida
ENT and Allergy Associates of FL Recruiting
Boynton Beach, Florida, United States, 33426
Contact: Amal El Kalimi-Short    561-737-8584    amal@lightent.com   
Principal Investigator: Joshua P Light, MD         
ENT and Allergy Associates of Florida, LLC Recruiting
Delray Beach, Florida, United States, 33484
Contact: O. Sandy DiBattista    561-939-0186    oadibattista@entaaf.com   
Principal Investigator: Mark Widick, MD         
Ear Research Foundation Recruiting
Sarasota, Florida, United States, 34239
Contact    941-556-4264      
Principal Investigator: Herbert Silverstein, MD         
United States, Kentucky
Advanced ENT and Allergy, PLLC Recruiting
Louisville, Kentucky, United States, 40220
Contact: Rhonda Dase    502-893-0159 ext 1184    rdase@advancedentandallergy.com   
Principal Investigator: Amy Ingram, MD         
United States, Louisiana
Tandem Clinical Research Recruiting
Marrero, Louisiana, United States, 70072
Contact: Kristen Clinton    504-934-8424    Kclinton@tandemclinicalresearch.com   
Principal Investigator: Adil Fatakia, MD, MBA         
United States, New York
Dent Neurosciences Research Center Recruiting
Amherst, New York, United States, 14226
Contact: Jennifer Cox    716-250-7002    jcox@dentinstitute.com   
Principal Investigator: Lixin Zhang, MD, PhD         
United States, North Carolina
Piedmont Ear, Nose & Throat Associates, PA Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Jessica Mack-Gill    336-768-3361    jmack@piedmontent.com   
Principal Investigator: Kenneth S Maxwell, MD         
United States, South Carolina
Carolina Ear, Nose & Throat Clinic/CENTRI Inc. Recruiting
Orangeburg, South Carolina, United States, 29118
Contact: Simone Ansley    803-870-8770    sansley700@gmail.com   
Principal Investigator: John F Ansley, MD         
Spartanburg/Greer ENT & Allergy Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Joe Carey    864-278-1429    jcarey@spartanburgent.com   
Principal Investigator: Erik D. Steiniger, MD         
United States, Utah
Chrysalis Clinical Research Recruiting
Saint George, Utah, United States, 84790
Contact: Rian Farr    435-656-1704    rfarr@sgccr.com   
Principal Investigator: G. Paul Doxey, MD         
Sponsors and Collaborators
Otonomy, Inc.
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Responsible Party: Otonomy, Inc.
ClinicalTrials.gov Identifier: NCT04829214    
Other Study ID Numbers: OTO-313-201
First Posted: April 2, 2021    Key Record Dates
Last Update Posted: June 11, 2021
Last Verified: May 2021
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.:
intratympanic injection
IT injection
gacyclidine
tinnitus
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases