Ignite Creation Date:
2024-05-06 @ 8:29 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02740387
Status:
TERMINATED
Last Update Posted:
2017-09-15
First Post:
2016-03-25
Brief Title:
Open Label Study of OTO-104 in Subjects With Menieres Disease
Sponsor:
Otonomy Inc
Organization:
Otonomy Inc
Study Overview
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 Menieres Disease
Status:
TERMINATED
Status Verified Date:
2017-09
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 a 1-year multicenter Phase 2 open-label safety study in subjects with unilateral Menieres 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 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