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

Launched by BOEHRINGER INGELHEIM · Jul 7, 2014

Keywords

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Gender

ALL

Eligibility criteria

• 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