Efficacy and Safety of Meloxicam Suspension Versus Diclofenac Suspension or Nimesulide Suspension in Patients With a Diagnosis of Acute, Non-bacterial Pharyngitis, Pharyngotonsillitis or Laryngitis

Study Overview
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Brief Summary
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The objective of this study was to assess the clinical efficacy and safety of meloxicam suspension 0.25 mg/kg/day once a day, versus diclofenac suspension 1 mg/kg/day twice a day or nimesulide suspension 4 mg/kg/day twice a day, after five days of treatment in patients with a diagnosis of acute, non-bacterial pharyngitis, pharyngotonsillitis or laryngitis

Official Title
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Randomized, Open-label, Controlled Trial to Assess the Clinical Efficacy and Safety of Meloxicam Suspension 0.25 mg/kg/Day Once a Day, Versus Diclofenac 1 mg/kg/Day Twice a Day or Nimesulide 4 mg/kg/Day Twice a Day, for Five Days in the Treatment of Patients With Acute, Non-bacterial Pharyngitis, Pharyngotonsillitis or Laryngitis

Conditions
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Pharyngitis

Intervention / Treatment
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* Drug: Meloxicam
* Drug: Diclofenac
* Drug: Nimesulide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of both genders between 2 and 8 years old Outpatients, with onset of symptoms not more than 72 hours prior to presentation, patients with acute non-bacterial pharyngitis or pharyngotonsillitis diagnosed according to the following criteria: Spontaneous pharyngeal pain, pharyngeal pain upon swallowing, pharyngeal and/or tonsillar hyperemia, absence of purulent plaques, pharyngeal smear negative for ß-hemolytic Streptococcus or Strepto Test® and Treatment with an Non-steroidal anti-inflammatory drugs (NSAID) required or recommended Exclusion Criteria: Known or suspected hypersensitivity to study medications or NSAID's Pharyngeal smear positive for ß-hemolytic Streptococcus treatment with antimicrobials prior to enrolment in the study Chronic infection, infectious mononucleosis, peptic ulcer disease that has been active in the previous 6 months Asthma nasal polyps angioneurotic edema or urticaria after the administration of aspirin or NSAID's Concomitant treatment with anticoagulants (including heparin), lithium or methotrexate Concomitant administration of other NSAID's (including high dose aspirin) or analgesics, except authorized rescue drugs Administration of any NSAID during the three previous days or of analgesics within six hours prior to the administration of the first study drug dose Treatment with corticosteroids at the time of enrollment or within the two previous months Known liver, renal or hematological disease Participation in another clinical trial during the study period or during the previous month Previous enrollment in this study Inability to comply with the protocol Suspected acute bacterial pharyngitis or pharyngotonsillitis (under the following clinical criteria): Clinical presentation characterized by a rapid onset, very high fever (>38.5°C), severe pharyngeal pain, cervical adenopathy, intense headache, purulent pharyngeal plaques, evidence of peritonsillar abscess or phlegmon

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 8 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meloxicam suspension<br> | Drug: Meloxicam<br> <br> |
| Active Comparator: Diclofenac suspension<br> | Drug: Diclofenac<br> <br> |
| Active Comparator: Nimesulide suspension<br> | Drug: Nimesulide<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in spontaneous pharyngeal pain |  | baseline, 5 days | 
| Change in pharyngeal pain on deglutition (dysphagia) |  | baseline, 5 days | 
| Change in pharyngeal hyperemia |  | baseline, 5 days | 
| Change in systemic manifestations (fever, adenomegaly and general malaise) |  | baseline, 5 days | 
| Incidence of adverse events |  | baseline, 5 days |