At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 39 enrolled
Drug / intervention
OTO-201drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating OTO-201 for Acute Otitis Media and AOMT. Completed, enrolled 39 participants across 5 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Otitis Media, AOMT
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartMar 2015
First PostedApr 2015
Primary CompletionMay 2015
TodayJul 2026
First PostedApr 3, 2015
Enrollment StartMar 1, 2015
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 11.2 years ago
Interventions
OTO-201drug