At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 38 enrolled
Drug / intervention
60 mg/kg azithromycin ER +1 moredrug
Likely dose
60 mg/kg azithromycin ERfrom 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 Open Label, Randomized, Single Dose, Parallel Arm Study To Determine Pharmacokinetics Of Azithromycin Following Oral Administration Of Immediate-Release Or Extended-Release Formulation In Pediatric Subjects With Acute Otitis Media
In Brief
A Phase 2 clinical trial evaluating 60 mg/kg azithromycin ER and 30 mg/kg azithromycin IR for Acute Otitis Media. Completed, enrolled 38 participants across 2 sites.
Detailed Summary
The purpose of this study was to determine the pharmacokinetics (PK), safety and clinical response following a single dose of either 30 mg/kg IR (Immediate Release) or 60 mg/kg ER (Extended Release) formulation in pediatric subjects 6 months to 6 years of age inclusive.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Otitis Media
CountriesCosta Rica
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2008
Enrollment StartDec 2008
Primary CompletionFeb 2009
TodayJul 2026
First PostedNov 24, 2008
Enrollment StartDec 1, 2008
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.6 years ago
Interventions
60 mg/kg azithromycin ERdrug
subjects taken 60 mg/kg azithromycin ER
30 mg/kg azithromycin IRdrug
subjects taken 30 mg/kg azithromycin IR (Immediate Release)