NCT01084525

OTO-104 for Meniere's Disease

A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 1B Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Otonomy, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Meniere's Disease

Interventions

Type	Name	Description
DRUG	OTO-104 (steroid) 3 mg	OTO-104 3 mg dose cohort, single intratympanic injection.
DRUG	Placebo	Placebo arm will be conducted in parallel with each OTO-104 dose cohort.
DRUG	OTO-104 (steroid) 12 mg	Sequential dose cohort escalation to OTO-104 12 mg dose cohort will occur pending the safety evaluation of 28 day follow up safety data for the OTO-104 3 mg dose cohort. OTO-104 12mg dose cohort is also a single intratympanic injection.

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-03-01
• Completion: 2011-04-01
• First posted: 2010-03-10
• Last updated: 2011-06-08

Locations

15 sites across 1 country: United States