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

NCT00799838 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2014-10-24

No results posted yet for this study

Summary

The purpose of this study is to evaluate the inflammatory symptoms and signs (hyperemia, edema and pain) reduction after 24 hours of treatment with ketoprofen drops when associated to amoxicillin.

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

Sponsors & Collaborators

Principal Investigators

  • Jaderson Lima, MD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Brazil

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00799838 on ClinicalTrials.gov