NCT00377260View on ClinicalTrials.gov

Acute Otitis Media (AOM) Therapy Trial in Young Children

PHASE4CompletedINTERVENTIONAL
Enrollment

291

Participants

Timeline

Start Date

November 30, 2006

Primary Completion Date

April 30, 2009

Study Completion Date

April 30, 2009

Conditions
Acute Otitis Media
Interventions
DRUG

amoxicillin-clavulanate

Augmentin ES-600™: Amoxicillin-clavulanate potassium (600/42.9 mg per 5 mL), administered at a dose of 90/6.4 mg/kg/day in 2 divided doses for 10 days with strawberry cream flavor.

DRUG

Placebo

Same base formulation of the licensed product Augmentin ES-600™, with the same strawberry cream flavor.

Trial Locations (1)

15213

Children's Hospital of Pittsburgh, Pittsburgh

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

University of Pittsburgh

OTHER

NCT00377260 - Acute Otitis Media (AOM) Therapy Trial in Young Children | Biotech Hunter | Biotech Hunter