drugset / Trial / NCT02600559
Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
NaSingle-groupOpen-labelTreatment
Summary
This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement with common concurrent surgeries and any middle ear effusion status.
Timeline
- Start
- 2015-10
- Primary completion
- 2016-07
- Completion
- 2016-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ciprofloxacin | Small molecule | 6 mg | — |