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

NCT ID: NCT02740387

Last Updated: 2017-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-09-30

Brief Summary

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This is a 1-year, multicenter, Phase 2, open-label safety study in subjects with unilateral Meniere's disease. Subjects will receive 1 intratympanic (IT) injection of 12 mg OTO-104 at 3-month intervals for a total of 4 injections total.

Detailed Description

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Conditions

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Meniere's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OTO-104

12 mg dexamethasone

Group Type EXPERIMENTAL

OTO-104

Intervention Type DRUG

Interventions

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OTO-104

Intervention Type DRUG

Other Intervention Names

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Single intratympanic injection 12 mg OTO-104

Eligibility Criteria

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Inclusion Criteria

* Subject has a diagnosis of definite unilateral Meniere's disease.
* Subject agrees to maintain their current standard of care treatments for Meniere's disease while on-study.

Exclusion Criteria

* Subject has an infection in the ear, sinuses, or upper respiratory system.
* Subject is pregnant or lactating.
* Subject has a history of immunodeficiency disease.
* Subject has active or recent (\<1 month prior to screening) middle ear disease, including but not limited to: chronic otitis media, acute otitis media, middle ear effusions, middle ear atelectasis, or cholesteatoma.
* Subject has experienced an adverse reaction to intratympanic injection of steroids.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 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

Principal Investigators

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Kathie Bishop, PhD

Role: STUDY_CHAIR

Otonomy, Inc.

Locations

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London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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104-201505

Identifier Type: -

Identifier Source: org_study_id