Clinical Trial: OTO-104 for Meniere's Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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'

Brief 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 Summary: 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.
Sponsor: Otonomy, Inc.

Current Primary Outcome: The primary objective of this study is to evaluate the safety and tolerability of two ascending OTO-104 doses relative to placebo. Safety assessments will be performed for 3 months post single intratympanic injection of OTO-104 or placebo. [ Time Frame: 3 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The secondary objective of this study is to evaluate the clinical activity of two OTO-104 doses relative to placebo. Change in baseline for vertigo frequency will be evaluated with descriptive statistics. [ Time Frame: 3 months ]
  • The impact of tinnitus on activities of daily living will be measured. [ Time Frame: 3 months ]
  • Hearing loss in the affected ear will be measured by audiometric examination. [ Time Frame: 3 months ]
  • Quality of life will be measured by patient reported questionnaire. [ Time Frame: 3 months ]
  • Severity of vertigo episodes will be measured by the patient reported vertigo score. [ Time Frame: 3 months ]


Original Secondary Outcome: Same as current

Information By: Otonomy, Inc.

Dates:
Date Received: March 8, 2010
Date Started: March 2010
Date Completion:
Last Updated: June 7, 2011
Last Verified: June 2011