At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 95 enrolled
Drug / intervention
6 mg ciprofloxacin +2 moredrug
Likely dose
6 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 1-Month, Prospective, Multicenter, Randomized, Dose-Ranging, Sham-Controlled, Blinded Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Media With Tympanostomy Tubes in Pediatric Subjects
In Brief
A Phase 2 clinical trial evaluating 6 mg ciprofloxacin, 12 mg ciprofloxacin, and 1 other intervention for Acute Otitis Media and AOMT. Completed, enrolled 95 participants across 1 site.
Detailed Summary
Dose Ranging Study of OTO-201 in AOMT
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Otitis Media, AOMT
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartFeb 2016
First PostedMar 2016
Primary CompletionJun 2016
Study CompletionJul 2016
TodayJul 2026
First PostedMar 25, 2016
Enrollment StartFeb 1, 2016
Primary CompletionJun 1, 2016
Study CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 10.3 years ago
Interventions
6 mg ciprofloxacindrug
Single administration of OTO-201
12 mg ciprofloxacindrug
Single administration of OTO-201
Shamother