OTO-104 for the Treatment of Meniere's Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Meniere's Disease

In brief

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

Key facts

Study ID

NCT01412177

Run by

Otonomy, Inc.

People needed

154

Starts

2013-11-01

Expected to finish

2015-04-01

Last updated by the study team

2015-09-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Subjects currently on a low-salt diet and/or diuretic at the time of screening agree to continue this treatment throughout the study.

You may not qualify if…

• 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.

Where it is running

• Many sites in US and Canada. Refer to the contact info listed below. — San Diego, California, United States
• UC Health Otolaryngology - Head and Neck Surgery — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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