NCT01755286

OTO-201 for Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Otonomy, Inc. · Industry
• Sex: All
• Age: 6 Months – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement

Interventions

Type	Name	Description
DRUG	OTO-201	Single intra-operative injection
DRUG	Placebo	Single intratympanic injection
DRUG	Sham	Simulated single intratympanic injection

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-12-24
• Last updated: 2013-06-19

Locations

1 site across 1 country: United States