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

Completed · Phase 1 · Has a placebo group

Conditions studied: Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement

In brief

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.

Key facts

Study ID
NCT01755286
Run by
Otonomy, Inc.
People needed
83
Starts
2012-12-01
Expected to finish
2013-06-01
Last updated by the study team
2013-06-19

Who can join

Age: 1 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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