At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 470 enrolled
Drug / intervention
EXE844 Sterile Otic Suspension, 0.3% +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.
Safety and Efficacy of EXE844 Otic Suspension in the Treatment of Otitis Media at Time of Tympanostomy Tube Insertion
In Brief
A Phase 3 clinical trial evaluating EXE844 Sterile Otic Suspension, 0.3% and Tympanostomy Tube Insertion for Otitis Media With Effusion in Children and Otitis Media Recurrent. Completed, enrolled 470 participants.
Detailed Summary
The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 2015
Enrollment StartJun 2015
Primary CompletionJun 2016
TodayJul 2026
First PostedMay 1, 2015
Enrollment StartJun 25, 2015
Primary CompletionJun 15, 2016
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 11.2 years ago
Interventions
EXE844 Sterile Otic Suspension, 0.3%drug
Tympanostomy Tube Insertionprocedure
Surgical procedure for treating pediatric cases of recurrent or chronic otitis media