At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 112 enrolled
Drug / intervention
Amoxicillin-Clavulanate potassiumdrug
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.
Reduced Clavulanate Formulation of Amoxicillin-Clavulanate in Children 6-23 Months With Acute Otitis Media
In Brief
A Phase 3 clinical trial evaluating Amoxicillin-Clavulanate potassium for Acute Otitis Media. Completed, enrolled 112 participants across 1 site.
Detailed Summary
To evaluate the safety profile of amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day (formulation 1) or at 80/2.85 mg/kg/day (formulation 2) in two divided doses for 10 days. Investigators will focus on the proportion of subjects who develop protocol-defined diarrhea and proportion who develop diaper dermatitis that occasions the prescription of antifungal medication.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Otitis Media
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartDec 2015
First PostedDec 2015
Primary CompletionDec 2016
Study CompletionJul 2017
TodayJul 2026
First PostedDec 15, 2015
Enrollment StartDec 1, 2015
Primary CompletionDec 1, 2016
Study CompletionJul 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 10.5 years ago
Interventions
Amoxicillin-Clavulanate potassiumdrug