Ignite Creation Date:
2024-05-05 @ 10:21 PM
Last Modification Date:
2024-10-26 @ 10:17 AM
Study NCT ID:
NCT01084525
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2010-03-08
Brief Title:
OTO-104 for Menieres Disease
Sponsor:
Otonomy Inc
Organization:
Otonomy Inc
Study Overview
Official Title:
A Prospective Randomized Double-blind Placebo-controlled Multicenter Phase 1B Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Menieres Disease
Status:
COMPLETED
Status Verified Date:
2011-06
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 safety of OTO-104 in subjects with unilateral Menieres disease The effectiveness of OTO-104 to reduce the symptoms of Menieres disease will also be evaluated
Detailed Description:
Menieres disease is a debilitating disorder of the inner ear which includes symptoms such as vertigo tinnitus hearing loss and aural fullness Menieres disease may result from an imbalance of fluid in the inner ear Several studies have shown that corticosteroids may help manage this imbalance yet the effect does not last very long OTO-104 is a longer lasting corticosteroid which could provide significant benefit to patients with Menieres disease
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