Expired Study
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San Diego, California


Purpose:

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


Criteria:

Inclusion Criteria includes, but is not limited to: - 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 includes, but is not limited to: - 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.


NCT ID:

NCT02612337


Primary Contact:

Study Chair
Kathie Bishop, PhD
Otonomy, Inc.


Backup Contact:

N/A


Location Contact:

San Diego, California
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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