Study of OTO-104 in Subjects With Unilateral Meniere's Disease

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-21

Study Completion Date

2017-09-15

Brief Summary

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The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.

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Detailed Description

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Conditions

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Meniere's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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OTO-104

12 mg dexamethasone

Group Type EXPERIMENTAL

OTO-104

Intervention Type DRUG

Single intratympanic injection of 12 mg OTO-104

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single intratympanic injection of placebo

Interventions

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OTO-104

Single intratympanic injection of 12 mg OTO-104

Intervention Type DRUG

Placebo

Single intratympanic injection of placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo for the 2 months prior to the study lead-in period.
* Subject has experienced active vertigo during the lead-in period.
* Subject has documented asymmetric sensorineural hearing loss.
* Subject agrees to maintain their current treatments for Meniere's disease while on-study.

Exclusion Criteria

* Subject is pregnant or lactating.
* Subject has a history of immunodeficiency disease.
* Subject has a history of previous endolymphatic sac surgery.
* Subject has a history of previous use of intratympanic (IT) gentamicin in the affected ear.
* Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
* Subject has experienced an adverse reaction to IT injection of steroids.
* Subject has used an investigational drug or device in the 3 months prior to screening.
* Subject has previously been randomized to a trial of OTO-104.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No