At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 103 enrolled
Drug / intervention
OP0201 +2 morecombination
Likely dose
OP0201 20mgfrom 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 Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months
In Brief
A Phase 2 clinical trial evaluating OP0201, Placebo, and 1 other intervention for Acute Otitis Media. Completed, enrolled 103 participants across 1 site.
Detailed Summary
The purpose of this study is to develop a better understanding of the safety, tolerability and efficacy of intranasal OP0201 as an adjunct treatment to oral antibiotics for the treatment of Acute Otitis Media (AOM) in infants and children.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Otitis Media
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJan 2019
Enrollment StartFeb 2019
Primary CompletionMar 2020
Study CompletionMar 2020
TodayJul 2026
First PostedJan 28, 2019
Enrollment StartFeb 21, 2019
Primary CompletionMar 9, 2020
Study CompletionMar 26, 2020
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 7.4 years ago
Interventions
OP0201combination
OP0201 20mg per day in two divided doses for 10 days
Placebocombination
Placebo 0mg per day in two divided doses for 10 days
Amoxicillin-clavulanatedrug
Oral Amoxicillin-clavulanate in two divided doses for 10 days