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TERMINATEDPhase 2NCT02740387

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

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 interval...

Lead sponsor: Otonomy, Inc.•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Otonomy, Inc.

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: September 15, 2017Terms

Trial snapshot

StatusTERMINATED

PhasePHASE2

Enrollment34

Start dateJun 2016

Last updatedSep 15, 2017

Condition

Meniere's Disease

Locations shown

Call Otonomy call center for trial locations

London, Ontario

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2017Data synced to Clareo: May 17, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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