At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 262 enrolled
Drug / intervention
12 mg ciprofloxacin +1 moredrug
Likely dose
12 mg ciprofloxacinfrom 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 Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, Phase 3 Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Externa
In Brief
A Phase 3 clinical trial evaluating 12 mg ciprofloxacin and Sham Control for Acute Otitis Externa and Swimmer's Ear. Completed, enrolled 262 participants across 2 sites in 2 countries.
Detailed Summary
This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external auditory canal of the affected ear(s).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Otitis Externa, Swimmer's Ear
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartJun 2016
First PostedJun 2016
Primary CompletionNov 2016
Study CompletionDec 2016
TodayJul 2026
First PostedJun 15, 2016
Enrollment StartJun 1, 2016
Primary CompletionNov 1, 2016
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.0 years ago
Interventions
12 mg ciprofloxacindrug
Single administration of OTO-201
Sham Controldrug
Simulated, single adminstration