Pharyngitis
Conditions
Brief summary
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
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 8 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Outcome results
None listed