Clinical Trial: A 6-Month Extension Study of OTO-104 in Meniere's Disease
Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional
Official Title: A 6-Month, Multicenter, Phase 3, Open-Label Extension Safety Study of OTO-104 Given At 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease
Brief Summary: This is an open-label extension study of a single intratympanic injection of OTO-104 given every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study 104-201403 (1-Year, Phase 2, Safety Study of OTO-104) or 104-201508 (Phase 3 Study of OTO-104) in order to be eligible for this open-label extension study.
Detailed Summary:
Sponsor: Otonomy, Inc.
Current Primary Outcome:
- Safety as assessed by adverse events [ Time Frame: 6 Months ]Evaluation of adverse events
- Safety as assessed by otoscopic exams [ Time Frame: 6 Months ]Evaluation of otoscopic exams
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Otonomy, Inc.
Dates:
Date Received: May 9, 2016
Date Started: August 2016
Date Completion: April 2018
Last Updated: April 12, 2017
Last Verified: April 2017