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

Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement
• Otitis Media with Effusion

• NCT number: NCT01755286
• Study type: Interventional
• Source: Otonomy, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: December 2012
• Completion date: June 2013