OTO-104 for Meniere's Disease

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the safety of OTO-104 in subjects with unilateral Meniere's disease. The effectiveness of OTO-104 to reduce the symptoms of Meniere's disease will also be evaluated.

Clinical Trial Description

Meniere's disease is a debilitating disorder of the inner ear which includes symptoms such as vertigo, tinnitus, hearing loss and aural fullness. Meniere's disease may result from an imbalance of fluid in the inner ear. Several studies have shown that corticosteroids may help manage this imbalance yet the effect does not last very long. OTO-104 is a longer lasting corticosteroid which could provide significant benefit to patients with Meniere's disease. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01084525
Study type	Interventional
Source	Otonomy, Inc.
Contact
Status	Completed
Phase	Phase 1
Start date	March 2010
Completion date	April 2011

View Details

See also
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Terminated	`NCT02706730` - A 6-Month Extension Study of OTO-104 in Meniere's Disease	Phase 3
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