NCT03818815 - 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 | Biotech Hunter

Enrollment

103

Participants

Timeline

Start Date

February 21, 2019

Primary Completion Date

March 9, 2020

Study Completion Date

March 26, 2020

Conditions

Acute Otitis Media

Interventions

COMBINATION_PRODUCT

OP0201

OP0201 20mg per day in two divided doses for 10 days

COMBINATION_PRODUCT

Placebo

Placebo 0mg per day in two divided doses for 10 days

DRUG

Amoxicillin-clavulanate

Oral Amoxicillin-clavulanate in two divided doses for 10 days

Trial Locations (1)

UPMC Children's Hospital of Pittsburgh - General Academic Pediatrics Oakland Medical Building, Pittsburgh