106
Participants
Start Date
November 30, 2008
Primary Completion Date
June 30, 2013
Study Completion Date
June 30, 2013
Ketoprofen
"Formulation: oral solution 20mg/mL~Route of administration: oral~Dose regimen: 1 drop/Kg for children aged between 4 to 6 years old or 25 drops for children from 7 to 11 years old administered t.i.d"
Placebo (for Ketoprofen)
"Formulation: oral solution~Route of administration: oral~Dose regimen: 1 drop/Kg for children aged between 4 to 6 years old or 25 drops for children from 7 to 11 years old administered t.i.d"
Amoxicillin
"Formulation: suspension 125mg/5 mL~Route of administration: oral~Dose regimen: 20-40mg/Kg/day administered t.i.d"
Sanofi-Aventis Administrative Office, São Paulo
Lead Sponsor
Sanofi
INDUSTRY