At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 331 enrolled
Drug / intervention
DF289 +2 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.
A Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution Compared to DF289 Otic Solution and to DF277 Otic Solution in the Treatment of Acute Otitis Media With Tympanostomy Tubes (AOMT) in Pediatric Patients
In Brief
A Phase 3 clinical trial evaluating DF289, DF277, and 1 other intervention for Acute Otitis Media. Completed, enrolled 331 participants across 1 site.
Detailed Summary
The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating middle ear infections in children with ear tubes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Otitis Media
CountriesSpain
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2011
First PostedJul 2011
Primary CompletionMay 2013
Study CompletionJun 2013
TodayJul 2026
First PostedJul 28, 2011
Enrollment StartJun 1, 2011
Primary CompletionMay 1, 2013
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 14.9 years ago
Interventions
DF289drug
Ear drops
DF277drug
Ear drops
DF289 plus DF277drug
Ear drops