Trials / Completed
CompletedNCT02408796
Open-Label Study of OTO-201 for Treatment of AOMT
A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Supra-Tympanostomy Tube Administration for Treatment of Acute Otitis Media With Tympanostomy Tubes in Pediatric Subjects
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Otonomy, Inc. · Industry
- Sex
- All
- Age
- 6 Months – 17 Years
- Healthy volunteers
- Not accepted
Summary
This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT). Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear(s). The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with AOMT.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OTO-201 |
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2015-05-01
- Completion
- 2015-05-01
- First posted
- 2015-04-03
- Last updated
- 2020-10-19
- Results posted
- 2020-09-23
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02408796. Inclusion in this directory is not an endorsement.