Clinical Trial: Study of OTO-104 in Subjects With Unilateral Meniere's Disease
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease
Brief Summary: The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.
Detailed Summary:
Sponsor: Otonomy, Inc.
Current Primary Outcome: Reduction in number of definitive vertigo days compared to placebo as assessed by a daily diary [ Time Frame: 3 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in hearing from baseline as assessed by audiometry [ Time Frame: 3 months ]
- Change in the condition of the ear from baseline as assessed by otoscopic examinations [ Time Frame: 3 months ]
- Evaluation of adverse events as a measure of safety and tolerability [ Time Frame: 3 months ]
- Impact of vertigo experience on daily activities [ Time Frame: 3 months ]Questionnaire
Original Secondary Outcome: Same as current
Information By: Otonomy, Inc.
Dates:
Date Received: March 10, 2016
Date Started: March 2016
Date Completion: October 2017
Last Updated: May 5, 2017
Last Verified: May 2017
