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

Phase 4TerminatedNCT00799838

Sanofi106 enrolled

Overview

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.

The total duration of the study period per patient is 10 ± 1 day

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

106

Conditions

Pharyngotonsillitis

Interventions

KetoprofenDRUG

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)DRUG

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

AmoxicillinDRUG

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

Eligibility

Sex: ALLMin age: 4 YearsMax age: 11 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi-Aventis Administrative Office

São Paulo, Brazil

Outcomes

Primary Outcomes

Number of patients with reduction of inflammatory signs and symptoms after 24 hours of treatment

Time frame: 24 hours

Secondary Outcomes

Number of patients with reduction of inflammatory signs and symptoms after 72 hours of treatment

Time frame: 72 hours

Number of patients with reduction of inflammatory signs and symptoms with no use of rescue medication

Time frame: 24 hours and 72 hours

Number of patients who used rescue medication after randomization.

Time frame: 72 hours

Data from ClinicalTrials.gov

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