Efficacy and Safety of Meloxicam vs. Naproxen Sodium in Patients With Acute Non Bacterial Pharyngitis or Pharyngo-tonsillitis

Inclusion criteria

• Male or female aged 18 years or above
• Ambulatory patients
• Start of symptoms within the previous 24 hours
• Patients suffering from acute non bacterial pharyngitis or pharyngo-tonsillitis diagnostic, under the following criteria:

• spontaneous pharyngeal pain presence greater than 35 mm on a 100 mm visual analog scale (VAS)
• Pharyngeal pain presence on swallowing greater than 35 mm on a 100 mm VAS
• Pharyngeal and/or amygdaline hyperemia
• Absence of purulent plaques
• Negative test for β-haemolytic Streptococcus on pharyngeal exudate
• Therapy with NSAID (Non-Steroid Anti-Inflammatory Drug) is required or recommended
• Patient's informed consent in accordance with local law and ICH GCP (International Conference of Harmonization Good Clinical Practice) , before inclusion into the the trial

Exclusion criteria

• Suspicion of acute pharyngitis or pharyngo-tonsillitis from bacterial origin by clinical criteria; Several impairment of patients condition, indicated by one or more or the following symptoms:

• Extremely rapid onset of clinical picture
• Very high fever (>38.5°C)
• Severe pharyngeal pain
• Cervical adenopathy
• Intense headache
• Purulent pharyngeal plaques, evidence of peritonsillar abscess or phlegmon
• Known or suspected hypersensitivity to the trial drug or NSAIDs
• Positive test for β-haemolytic Streptococcus on pharyngeal exudate
• Therapy with antimicrobial agents prior to start of the trial
• Chronic infections
• Infectious mononucleosis
• Active peptic ulcer within the past 6 months
• Pregnancy or breast feeding precaution: attention should be drawn to reports that NSAIDs were reported to decrease the efficacy of intrauterine devices
• Asthma, nasal polyps, angioneurotic edema or urticaria following the administration of aspirin or NSAIDs
• Concomitant treatment with anti-coagulants (including heparin), lithium or methotrexate
• Concomitant administration of other NSAIDs (including high-dose > 1500 mg at day aspirin) or analgesic agents
• Administration of any NSAID during the last three days or analgesics 6 hours prior to the first administration of the trial drug
• Present treatment or treatment within the last two months with corticosteroids
• Historically know of impaired renal function (serum urea > 125 % of the upper limit of normal range; serum creatinine > 150 % of the upper limit of normal range)
• Historically know of severe liver injury (alanine amino transferase ALAT > 2 x the upper normal range limit or aspartate amino transferase ASAT > 2 x the upper normal range limit)
• Historically know of hematological disorder (platelet count < 100,000/mm3, leucocyte count < 3,000/mm3)
• Participation in another clinical trial during this study or during the previous month
• Previous participation in this trial
• Patient unable to comply with the protocol