Clinical Trial: Open Label Study of OTO-104 in Subjects With Meniere's Disease
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A 1-Year, Phase 2, Open-Label Safety Study of OTO-104 Given at 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease
Brief Summary: This is a 1-year, multicenter, Phase 2, open-label safety study in subjects with unilateral Meniere's disease. Subjects will receive 1 intratympanic (IT) injection of 12 mg OTO-104 at 3-month intervals for a total of 4 injections total.
Detailed Summary:
Sponsor: Otonomy, Inc.
Current Primary Outcome: Evaluation of adverse events as a measure of safety and tolerability [ Time Frame: Up to 1 Year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in hearing from baseline as assessed by audiometry [ Time Frame: Up to 1 Year ]
- Changes in patient condition assessed by otoscopy [ Time Frame: Up to 1 Year ]
- Changes in patient condition assessed by tympanometry [ Time Frame: Up to 1 Year ]
Original Secondary Outcome: Same as current
Information By: Otonomy, Inc.
Dates:
Date Received: March 25, 2016
Date Started: June 2016
Date Completion: October 2017
Last Updated: April 12, 2017
Last Verified: April 2017
