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

• Status: Terminated
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Amoxicillin; Ketoprofen

Criteria

Inclusion Criteria:

• Quick-test positive for Streptococcus pyogenes;

• Indication for treatment with amoxicillin according to labeling and physician's clinical evaluation;

• Pain (for swallowing) evaluated by Wong Baker Faces Pain scale with at least grade 3;

• Presence of at least two of the follow symptoms:

• Hyperemia and edema evaluated with at least 2 out of 4 crosses

• Fever in the previous 48 hours

• Cervical adenomegaly

• Tonsilla with erythema or erythema and white exsudate.

Exclusion Criteria:

• History of cardiovascular, gastrointestinal, metabolic or psychiatric conditions;

• History and laboratorial confirmation of hematologic, hepatic or renal disorders;

• Use of nonsteroidal antiinflammatory drugs (NSAID) during the last 3 weeks and gastroesophageal reflux during the last 6 months;

• Use of analgesic or anti inflammatory medication (except Paracetamol) in the previous 12 hours;

• History of allergy or hypersensitivity to amoxicillin and/ or ketoprofen.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.