Evaluation of Inflammatory Symptoms Reduction With Amoxicillin + Ketoprofen in Acute Pharyngeal Tonsillitis in Pediatric Patients

PHASE4TerminatedINTERVENTIONAL
Enrollment

106

Participants

Timeline

Start Date

November 30, 2008

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

Conditions
Pharyngotonsillitis
Interventions
DRUG

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"

DRUG

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"

DRUG

Amoxicillin

"Formulation: suspension 125mg/5 mL~Route of administration: oral~Dose regimen: 20-40mg/Kg/day administered t.i.d"

Trial Locations (1)

Unknown

Sanofi-Aventis Administrative Office, São Paulo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT00799838 - Evaluation of Inflammatory Symptoms Reduction With Amoxicillin + Ketoprofen in Acute Pharyngeal Tonsillitis in Pediatric Patients | Biotech Hunter | Biotech Hunter