At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 75 enrolled
Drug / intervention
OTO-201 (ciprofloxacin)drug
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 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration for Treatment of Otitis Externa
In Brief
A Phase 2 clinical trial evaluating OTO-201 (ciprofloxacin) for Otitis Externa. Completed, enrolled 75 participants across 1 site.
Detailed Summary
This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa. Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with otitis externa.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOtitis Externa
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJul 2015
First PostedJul 2015
Primary CompletionNov 2015
TodayJul 2026
First PostedJul 30, 2015
Enrollment StartJul 1, 2015
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 10.9 years ago
Interventions
OTO-201 (ciprofloxacin)drug