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OTO-313 in Subjects With Subjective Tinnitus

NCT ID: NCT03918109

Last Updated: 2022-12-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-04

Study Completion Date

2020-05-29

Brief Summary

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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.

Detailed Description

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Conditions

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Tinnitus, Subjective

Keywords

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tinnitus, intratympanic injection, gacyclidine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double-blind, placebo-controlled, multicenter
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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OTO-313

Group Type EXPERIMENTAL

OTO-313

Intervention Type DRUG

single intratympanic injection of gacyclidine

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

single intratympanic injection of placebo

Interventions

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OTO-313

single intratympanic injection of gacyclidine

Intervention Type DRUG

Placebo

single intratympanic injection of placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otonomy, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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House Clinic

Los Angeles, California, United States

Site Status

California Head & Neck Specialists

San Diego, California, United States

Site Status

Colorado ENT and Allergy

Colorado Springs, Colorado, United States

Site Status

Silverstein Institute/Ear Research Foundation

Sarasota, Florida, United States

Site Status

ChicagoENT

Chicago, Illinois, United States

Site Status

Advanced ENT and Allergy

Louisville, Kentucky, United States

Site Status

Tandem Clinical Research, LLC

Marrero, Louisiana, United States

Site Status

Summit Medical Group

Berkeley Heights, New Jersey, United States

Site Status

Dent Neurosciences Research Center

Amherst, New York, United States

Site Status

Northwell Health, Hearing & Speech Center

New Hyde Park, New York, United States

Site Status

Northwell Health at ENT and Allergy Associates

White Plains, New York, United States

Site Status

Charlotte Eye Ear Nose & Throat Associates

Charlotte, North Carolina, United States

Site Status

Piedmont Ear, Nose, and Throat Associates

Winston-Salem, North Carolina, United States

Site Status

Worldwide Clinical Trials

San Antonio, Texas, United States

Site Status

Chrysalis Clinical Research

St. George, Utah, United States

Site Status

WVU Medicine

Morgantown, West Virginia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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313-201901

Identifier Type: -

Identifier Source: org_study_id