Clinical Trial: OTO-104 for the Treatment of Meniere's Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2b 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 vertigo frequency as measure of efficacy of OTO-104 in subjects with Meniere's disease [ Time Frame: 4 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Evaluation of adverse events, otoscopic exams, audiometry, Word Recognition Score and tympanometry as a measure of safety and tolerability [ Time Frame: 4 months ]
- Evaluation of tinnitus patient reported questionnaire and daily diary as a measure of impact of tinnitus on activities of daily living [ Time Frame: 4 months ]
- Evaluation of patient reported questionnaires as a measure of impact on patient daily activities [ Time Frame: 4 months ]
Original Secondary Outcome: Same as current
Information By: Otonomy, Inc.
Dates:
Date Received: July 31, 2011
Date Started: November 2013
Date Completion:
Last Updated: August 18, 2015
Last Verified: August 2015
