Ignite Creation Date:
2024-05-06 @ 8:16 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02706730
Status:
TERMINATED
Last Update Posted:
2022-12-14
First Post:
2016-03-08
Brief Title:
A 6-Month Extension Study of OTO-104 in Menieres Disease
Sponsor:
Otonomy Inc
Organization:
Otonomy Inc
Study Overview
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 Menieres Disease
Status:
TERMINATED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Negative Efficacy Results from the recently completed Phase 3 study 104-201506
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 104-201102 Phase 2b study of OTO-104 or 104-201506 Phase 3 study of OTO-104 in order to be eligible for this open-label extension study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None