Ignite Creation Date:
2024-05-06 @ 3:43 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02350998
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2015-01-21
Brief Title:
Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration
Sponsor:
Otonomy Inc
Organization:
Otonomy Inc
Study Overview
Official Title:
A 1-Month Prospective Multicenter Open-Label Study of OTO-201 Given as a Single Trans-Tympanic Tube Administration for Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects With Otitis Media Requiring Tympanostomy Tube Placement
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 1-month prospective multicenter open-label study in pediatric subjects with bilateral middle ear effusion requiring tympanostomy tube placement Eligible subjects will receive a single dose to each ear of 6 mg OTO-201 administered intraoperatively into the middle ear through the lumen of the tympanostomy tube trans-tympanostomy tube TTT The study is designed to characterize safety and any procedural issues associated with TTT drug administration of OTO-201
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