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

• Conditions: Pharyngotonsillitis; MedDRA version: 17.1Level: PTClassification code 10049140Term: PharyngotonsillitisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-004002-15-Outside-EU/EEA
• Lead Sponsor: Sanofi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-19
• Last Update Posted: 6 January 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Indication for treatment with amoxicillin according to labeling and physician's clinical evaluation.
•Quick-test positive for Streptococcus pyogenes.
•Pain (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 crosses from 4;
•Fever in the previous 48 hours;
•Cervical adenomegaly;
• Tonsilla with erythema or eythema and white exsudate

Are the trial subjects under 18? yes
Number of subjects for this age range: 210
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•History of cardiovascular, gastrointestinal, metabolic or psychiatric conditions.
•History and laboratorial confirmation of hematologic, hepatic or renal disorders.
•Use of NSAIDs 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified