Ignite Creation Date:
2024-05-06 @ 3:20 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02265393
Status:
COMPLETED
Last Update Posted:
2017-08-18
First Post:
2014-10-09
Brief Title:
A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Menieres Disease Located in United Kingdom
Sponsor:
Otonomy Inc
Organization:
Otonomy Inc
Study Overview
Official Title:
A 6-Month Prospective Randomized Multicenter Placebo-Controlled Safety Study of OTO-104 Given at 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Menieres Disease Followed by a 6-Month Open-Label Extension
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a 2-part study of OTO-104 in subjects with unilateral Menieres disease in the United Kingdom The first part is a randomized placebo-controlled study comparing the safety profile of 2 injections of OTO-104 or placebo spaced 3 months apart The second part is an open-label extension where all subjects will receive an additional 2 intratympanic injections of OTO-104 spaced 3 months apart Each subject will participate on the study for a total of 1 year
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