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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


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

See also
  Status Clinical Trial Phase
Completed NCT01949142 - OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement Phase 3
Completed NCT01949155 - OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement Phase 3