Ignite Creation Date:
2024-05-06 @ 2:00 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01949155
Status:
COMPLETED
Last Update Posted:
2016-11-11
First Post:
2013-09-20
Brief Title:
OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
Sponsor:
Otonomy Inc
Organization:
Otonomy Inc
Study Overview
Official Title:
Prospective Randomized Double-Blind Sham-Controlled Multicenter P3 Study of OTO-201 Given as a Single IT Injection For Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
Status:
COMPLETED
Status Verified Date:
2016-09
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:
The purpose of this study is to confirm the effectiveness safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement
Detailed Description:
This is a prospective randomized double-blind sham-controlled multicenter Phase 3 study of OTO-201 administered intraoperatively in pediatric subjects with bilateral middle ear effusion requiring TT tympanostomy tube placement One dose level 6 mg of OTO-201 was evaluated relative to sham empty syringe
Study subjects are required to have a clinical diagnosis of bilateral middle ear effusion requiring TT placement On the day of surgery prior to surgery eligible subjects were examined via otoscope to confirm bilateral middle ear effusion Subjects with bilateral middle ear effusion were randomized to either 6 mg OTO-201 or sham Subjects without bilateral effusion on the day of surgery were not randomized and were considered screen failures
Approximately 264 subjects are planned to be randomized to OTO-201 or sham using a 21 allocation ratio Randomization to OTO-201 or sham was stratified by age 6 months to 2 years or 2 years
Subjects are to visit the study site for safety assessments and otoscopic examination on Days 4 8 15 and 29 The assessment of otorrhea by the blinded assessor for the primary efficacy endpoint occurred on Days 4 8 and 15
Study subjects are required to have a clinical diagnosis of bilateral middle ear effusion requiring TT placement On the day of surgery prior to surgery eligible subjects were examined via otoscope to confirm bilateral middle ear effusion Subjects with bilateral middle ear effusion were randomized to either 6 mg OTO-201 or sham Subjects without bilateral effusion on the day of surgery were not randomized and were considered screen failures
Approximately 264 subjects are planned to be randomized to OTO-201 or sham using a 21 allocation ratio Randomization to OTO-201 or sham was stratified by age 6 months to 2 years or 2 years
Subjects are to visit the study site for safety assessments and otoscopic examination on Days 4 8 15 and 29 The assessment of otorrhea by the blinded assessor for the primary efficacy endpoint occurred on Days 4 8 and 15
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