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
Study CompletionJun 2014
TodayJul 2026
First PostedSep 24, 2013
Enrollment StartNov 1, 2013
Primary CompletionMay 1, 2014
Study CompletionJun 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