At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 33 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 Trans-Tympanic Tube Administration for Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects With Otitis Media Requiring Tympanostomy Tube Placement
In Brief
A Phase 3 clinical trial evaluating OTO-201 for Bilateral Middle Ear Effusion. Completed, enrolled 33 participants across 5 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBilateral Middle Ear Effusion
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJan 2015
First PostedJan 2015
Primary CompletionMar 2015
TodayJul 2026
First PostedJan 30, 2015
Enrollment StartJan 1, 2015
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 11.4 years ago
Interventions
OTO-201drug