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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Pharyngitis

Treatments: Drug: Meloxicam placebo low; Drug: Naproxen sodium placebo; Drug: Meloxicam high; Drug: Naproxen sodium; Drug: Meloxicam placebo high; Drug: Meloxicam low

Study type: Interventional

Funder types: Industry

Identifiers

NCT02183038

107.193

Details and patient eligibility

About

Study to assess the efficacy and tolerability of Meloxicam once daily dose of 7.5 mg and 15 mg compared with 1100 mg of naproxen sodium in the symptomatic treatment of acute non bacterial pharyngitis or pharyngo-tonsillitis, over a period of 5 days.

Enrollment: 390 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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390 participants in 3 patient groups

Meloxicam low & Placebo

Experimental group

Treatment:

Drug: Meloxicam low

Drug: Naproxen sodium placebo

Drug: Meloxicam placebo high

Meloxicam high & Placebo

Experimental group

Treatment:

Drug: Naproxen sodium placebo

Drug: Meloxicam high

Drug: Meloxicam placebo low

Naproxen sodium & Placebo

Active Comparator group

Treatment:

Drug: Naproxen sodium

Drug: Meloxicam placebo high

Drug: Meloxicam placebo low