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

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ClinicalTrials.gov Identifier: NCT02183038
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pharyngitis Drug: Meloxicam low Drug: Meloxicam high Drug: Naproxen sodium Drug: Meloxicam placebo low Drug: Meloxicam placebo high Drug: Naproxen sodium placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Double-blind Study to Compare Efficacy and Safety of Meloxicam 7.5 mg and 15 mg vs. Naproxen Sodium 1100 mg in the Symptomatic Treatment of Acute Non Bacterial Pharyngitis or Pharyngo-tonsillitis Over a Period of 5 Days
Study Start Date : July 1998
Actual Primary Completion Date : February 1999

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Meloxicam low & Placebo Drug: Meloxicam low
Drug: Meloxicam placebo high
Drug: Naproxen sodium placebo
Experimental: Meloxicam high & Placebo Drug: Meloxicam high
Drug: Meloxicam placebo low
Drug: Naproxen sodium placebo
Active Comparator: Naproxen sodium & Placebo Drug: Naproxen sodium
Drug: Meloxicam placebo low
Drug: Meloxicam placebo high



Primary Outcome Measures :
  1. Change in intensity of spontaneous pharyngeal pain [ Time Frame: Baseline, day 3 and 5 ]
  2. Change in intensity of pharyngeal pain on swallowing [ Time Frame: Baseline, day 3 and 5 ]

Secondary Outcome Measures :
  1. Final global assessment of efficacy by patient [ Time Frame: Day 5 ]
  2. Final global assessment of efficacy by investigator [ Time Frame: Day 5 ]
  3. Final global assessment of tolerability by patient [ Time Frame: Day 5 ]
  4. Final global assessment of tolerability by investigator [ Time Frame: Day 5 ]
  5. Occurrence of disease systemic manifestations (fever, and general malaise) [ Time Frame: up to 5 days ]
  6. Occurrence of pharyngeal hyperemia [ Time Frame: up to 5 days ]
  7. Assessment of patient status [ Time Frame: Day 5 ]
  8. Occurrence of treatment withdrawal due to lack of efficacy [ Time Frame: up to 5 days ]
  9. Occurrence of perforation, ulceration, bleeding (PUB) of the upper gastro-intestinal tract (stomach or duodenum) [ Time Frame: up to day 5 ]
  10. Intensity of adverse events [ Time Frame: up to 19 days ]
  11. Number of patients who withdraw due to adverse event [ Time Frame: up to 19 days ]
  12. Incidence of significant laboratory adverse events [ Time Frame: up to 19 days ]
  13. Occurrence and duration of hospital stay due to Gastro-Intestinal Serious Adverse Events (GI-SAE) [ Time Frame: up to 19 days ]
  14. Occurrence and duration of hospital stay due to adverse events related to trial drug administration [ Time Frame: up to 19 days ]
  15. Occurrence of an additional visit at physician due to gastro-intestinal adverse event (GI-AE) [ Time Frame: up to 19 days ]
  16. Number of patients with adverse events [ Time Frame: up to 19 days ]
  17. Number of patients with adverse events related to trial drug [ Time Frame: up to 19 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183038     History of Changes
Other Study ID Numbers: 107.193
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Pharyngitis
Tonsillitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Naproxen
Meloxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors