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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meloxicam suspension | Experimental |
| |
| Diclofenac suspension | Active Comparator |
| |
| Nimesulide suspension | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meloxicam | Drug |
| ||
| Diclofenac |
| 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 |
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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:
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):
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|
| Nimesulide | Drug |
|
| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000077239 | Meloxicam |
| D004008 | Diclofenac |
| C012655 | nimesulide |
| ID | Term |
|---|---|
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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