Trials / Completed
CompletedNCT02350998
Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration
A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Trans-Tympanic Tube Administration for Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects With Otitis Media Requiring Tympanostomy Tube Placement
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 33 (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 bilateral middle ear effusion requiring tympanostomy tube placement. Eligible subjects will receive a single dose to each ear of 6 mg OTO-201, administered intraoperatively into the middle ear through the lumen of the tympanostomy tube (trans-tympanostomy tube TTT). The study is designed to characterize safety and any procedural issues associated with TTT drug administration of OTO-201.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OTO-201 |
Timeline
- Start date
- 2015-01-01
- Primary completion
- 2015-03-01
- Completion
- 2015-03-01
- First posted
- 2015-01-30
- Last updated
- 2020-10-19
- Results posted
- 2020-09-23
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02350998. Inclusion in this directory is not an endorsement.