Trials / Completed
CompletedNCT02801370
Phase 3 Study of OTO-201 in Acute Otitis Externa
A Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, Phase 3 Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Externa
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 262 (actual)
- Sponsor
- Otonomy, Inc. · Industry
- Sex
- All
- Age
- 6 Months
- Healthy volunteers
- Not accepted
Summary
This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external auditory canal of the affected ear(s).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 12 mg ciprofloxacin | Single administration of OTO-201 |
| DRUG | Sham Control | Simulated, single adminstration |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2016-11-01
- Completion
- 2016-12-01
- First posted
- 2016-06-15
- Last updated
- 2020-10-19
- Results posted
- 2020-09-22
Locations
2 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT02801370. Inclusion in this directory is not an endorsement.