At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 266 enrolled
Drug / intervention
OTO-201 +1 moredrug
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.
Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, P3 Study of OTO-201 Given as a Single IT Injection For Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
In Brief
A Phase 3 clinical trial evaluating OTO-201 and Sham for Otitis Media With Effusion. Completed, enrolled 266 participants across 1 site.
Detailed Summary
The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOtitis Media With Effusion
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 2013
Enrollment StartNov 2013
Primary CompletionMay 2014
TodayJul 2026
First PostedSep 24, 2013
Enrollment StartNov 1, 2013
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 12.8 years ago
Interventions
OTO-201drug
Single, intratympanic injection
Shamdrug
Simulated single, intratympanic injection