Ignite Creation Date:
2024-05-06 @ 8:43 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02801370
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2016-06-13
Brief Title:
Phase 3 Study of OTO-201 in Acute Otitis Externa
Sponsor:
Otonomy Inc
Organization:
Otonomy Inc
Study Overview
Official Title:
A Prospective Randomized Double-Blind Sham-Controlled Multicenter Phase 3 Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Externa
Status:
COMPLETED
Status Verified Date:
2020-09
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 prospective randomized double-blind sham-controlled multicenter Phase 3 study in which eligible subjects with acute otitis externa AOE will be randomized to receive a single administration of either 12 mg OTO-201 or Sham-Control empty syringe to the external auditory canal of the affected ears
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