Ignite Creation Date:
2024-05-06 @ 1:12 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01755286
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2012-12-18
Brief Title:
OTO-201 for Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
Sponsor:
Otonomy Inc
Organization:
Otonomy Inc
Study Overview
Official Title:
A Prospective Randomized Double-Blind Placebo- and Sham-Controlled Multicenter Phase 1b Study of OTO-201 Given as a Single Intratympanic Injection for Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
Status:
COMPLETED
Status Verified Date:
2013-06
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 describe the safety and tolerability of two dose levels of OTO-201 placebo and sham when administered intra-operatively in pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement
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