At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 501 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.
An 8-Week, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
In Brief
A Phase 3 clinical trial evaluating OTO-201 (ciprofloxacin) for Otitis Media. Completed, enrolled 501 participants across 1 site.
Detailed Summary
This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement with common concurrent surgeries and any middle ear effusion status.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOtitis Media
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartOct 2015
First PostedNov 2015
Primary CompletionJul 2016
TodayJul 2026
First PostedNov 9, 2015
Enrollment StartOct 1, 2015
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.6 years ago
Interventions
OTO-201 (ciprofloxacin)drug