Trials / Completed
CompletedNCT02719158
Dose Ranging Study of OTO-201 in AOMT
A 1-Month, Prospective, Multicenter, Randomized, Dose-Ranging, Sham-Controlled, Blinded Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Media With Tympanostomy Tubes in Pediatric Subjects
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 95 (actual)
- Sponsor
- Otonomy, Inc. · Industry
- Sex
- All
- Age
- 6 Months – 17 Years
- Healthy volunteers
- Not accepted
Summary
Dose Ranging Study of OTO-201 in AOMT
Detailed description
This is a 1-month, prospective, multicenter, randomized, dose-ranging, sham-controlled, blinded study in which eligible subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT) will receive a single administration of 6 mg OTO-201, 12 mg OTO-201, or sham into the affected ear(s).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 6 mg ciprofloxacin | Single administration of OTO-201 |
| DRUG | 12 mg ciprofloxacin | Single administration of OTO-201 |
| OTHER | Sham |
Timeline
- Start date
- 2016-02-01
- Primary completion
- 2016-06-01
- Completion
- 2016-07-01
- First posted
- 2016-03-25
- Last updated
- 2020-10-19
- Results posted
- 2020-09-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02719158. Inclusion in this directory is not an endorsement.