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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Diclofenac; Meloxicam; Nimesulide

Criteria

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