Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2026-01-12 @ 5:19 AM
Study NCT ID:
NCT02600559
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2015-11-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
Sponsor:
Otonomy, Inc.
Organization:
Study Overview
Official Title:
An 8-Week, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
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 an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement with common concurrent surgeries and any middle ear effusion status.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: