drugset / Trial / NCT01755286
OTO-201 for Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
RandomizedSingle-groupTriple-blindTreatment
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.
Timeline
- Start
- 2012-12
- Primary completion
- 2013-06
- Completion
- 2013-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | OTO-201 | Unknown | 4 mg | Other |
| Subject | OTO-201 | Unknown | 12 mg | Other |