Ignite Creation Date:
2024-05-06 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03664674
Status:
COMPLETED
Last Update Posted:
2022-12-07
First Post:
2018-08-31
Brief Title:
Phase 3 Study of OTO-104 in Subjects With Unilateral Menieres Disease
Sponsor:
Otonomy Inc
Organization:
Otonomy Inc
Study Overview
Official Title:
A Prospective Randomized Double Blind Placebo-controlled Multicenter Phase 3 Efficacy and Safety Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Menieres Disease
Status:
COMPLETED
Status Verified Date:
2022-11
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:
The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Menieres disease
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None