At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 768 enrolled
Drug / intervention
AL-60371, 0.3% Otic Suspension +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 Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
In Brief
A Phase 3 clinical trial evaluating AL-60371, 0.3% Otic Suspension and AL-60371 Vehicle for Acute Otitis Externa. Completed, enrolled 768 participants.
Detailed Summary
The purpose of this study was to demonstrate the superiority of AL-60371, 0.3% Otic Suspension relative to AL-60371 Vehicle based on clinical cures at test-of-cure (TOC) for the treatment of acute otitis externa (AOE).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Otitis Externa
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2012
Enrollment StartMar 2012
Primary CompletionMay 2013
TodayJul 2026
First PostedFeb 20, 2012
Enrollment StartMar 1, 2012
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.4 years ago
Interventions
AL-60371, 0.3% Otic Suspensiondrug
AL-60371 Vehicleother
Inactive ingredients used as a placebo comparator