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

Study Overview
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Brief Summary
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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.

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

Official Title
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Local, Phase IV, Multicenter, Double-blind, Randomized, Parallel, With Two Treatment Arms, Placebo-controlled Study to Evaluate the Reduction of Inflammatory Symptoms in the Treatment of Bacterial Pharyngitis With Ketoprofen and Amoxicillin in Pediatric Patients.

Conditions
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Pharyngotonsillitis

Intervention / Treatment
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* Drug: Ketoprofen
* Drug: Placebo (for Ketoprofen)
* Drug: Amoxicillin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketoprofen + Amoxicillin<br>Ketoprofen + Amoxicillin for 3 days, then Amoxicillin alone for 7 days | Drug: Ketoprofen<br>* 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<br>Drug: Amoxicillin<br>* Formulation: suspension 125mg/5 mL Route of administration: oral Dose regimen: 20-40mg/Kg/day administered t.i.d<br>|
| Placebo Comparator: Amoxicillin<br>Placebo (for ketoprofen) + Amoxicillin for 3 days, then Amoxicillin alone for 7 days | Drug: Placebo (for Ketoprofen)<br>* 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<br>Drug: Amoxicillin<br>* Formulation: suspension 125mg/5 mL Route of administration: oral Dose regimen: 20-40mg/Kg/day administered t.i.d<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with reduction of inflammatory signs and symptoms after 24 hours of treatment |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with reduction of inflammatory signs and symptoms after 72 hours of treatment |  | 72 hours | 
| Number of patients with reduction of inflammatory signs and symptoms with no use of rescue medication |  | 24 hours and 72 hours | 
| Number of patients who used rescue medication after randomization. |  | 72 hours |