Trials / Completed
CompletedNCT02600559
Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
An 8-Week, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 501 (actual)
- Sponsor
- Otonomy, Inc. · Industry
- Sex
- All
- Age
- 6 Months – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OTO-201 (ciprofloxacin) |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2016-07-01
- Completion
- 2016-07-01
- First posted
- 2015-11-09
- Last updated
- 2020-10-19
- Results posted
- 2020-09-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02600559. Inclusion in this directory is not an endorsement.