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

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 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.

Study Overview

• Status: Completed
• Conditions: Pharyngitis
• Intervention / Treatment: Drug: Meloxicam low; Drug: Meloxicam placebo high; Drug: Naproxen sodium placebo; Drug: Meloxicam high; Drug: Meloxicam placebo low; Drug: Naproxen sodium

• Study Type: Interventional
• Enrollment (Actual): 390
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meloxicam low & Placebo	Drug: Meloxicam low; Drug: Meloxicam placebo high; Drug: Naproxen sodium placebo
Experimental: Meloxicam high & Placebo	Drug: Naproxen sodium placebo; Drug: Meloxicam high; Drug: Meloxicam placebo low
Active Comparator: Naproxen sodium & Placebo	Drug: Meloxicam placebo high; Drug: Meloxicam placebo low; Drug: Naproxen sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in intensity of spontaneous pharyngeal pain	Baseline, day 3 and 5
Change in intensity of pharyngeal pain on swallowing	Baseline, day 3 and 5

Secondary Outcome Measures

Outcome Measure	Time Frame
Final global assessment of efficacy by patient	Day 5
Final global assessment of efficacy by investigator	Day 5
Final global assessment of tolerability by patient	Day 5
Final global assessment of tolerability by investigator	Day 5
Occurrence of disease systemic manifestations (fever, and general malaise)	up to 5 days
Occurrence of pharyngeal hyperemia	up to 5 days
Assessment of patient status	Day 5
Occurrence of treatment withdrawal due to lack of efficacy	up to 5 days
Occurrence of perforation, ulceration, bleeding (PUB) of the upper gastro-intestinal tract (stomach or duodenum)	up to day 5
Intensity of adverse events	up to 19 days
Number of patients who withdraw due to adverse event	up to 19 days
Incidence of significant laboratory adverse events	up to 19 days
Occurrence and duration of hospital stay due to Gastro-Intestinal Serious Adverse Events (GI-SAE)	up to 19 days
Occurrence and duration of hospital stay due to adverse events related to trial drug administration	up to 19 days
Occurrence of an additional visit at physician due to gastro-intestinal adverse event (GI-AE)	up to 19 days
Number of patients with adverse events	up to 19 days
Number of patients with adverse events related to trial drug	up to 19 days

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 1998
• Primary Completion (Actual): February 1, 1999

Study Registration Dates

• First Submitted: July 4, 2014
• First Submitted That Met QC Criteria: July 7, 2014
• First Posted (Estimate): July 8, 2014

Study Record Updates

• Last Update Posted (Estimate): July 8, 2014
• Last Update Submitted That Met QC Criteria: July 7, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Tonsillitis; Pharyngitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Gout Suppressants; Naproxen; Meloxicam
• Other Study ID Numbers: 107.193