Efficacy and Safety of Meloxicam Suspension Versus Diclofenac Suspension or Nimesulide Suspension in Patients With a Diagnosis of Acute, Non-bacterial Pharyngitis, Pharyngotonsillitis or Laryngitis

Randomized, Open-label, Controlled Trial to Assess the Clinical Efficacy and Safety of Meloxicam Suspension 0.25 mg/kg/Day Once a Day, Versus Diclofenac 1 mg/kg/Day Twice a Day or Nimesulide 4 mg/kg/Day Twice a Day, for Five Days in the Treatment of Patients With Acute, Non-bacterial Pharyngitis, Pharyngotonsillitis or Laryngitis

The objective of this study was to assess the clinical efficacy and safety of meloxicam suspension 0.25 mg/kg/day once a day, versus diclofenac suspension 1 mg/kg/day twice a day or nimesulide suspension 4 mg/kg/day twice a day, after five days of treatment in patients with a diagnosis of acute, non-bacterial pharyngitis, pharyngotonsillitis or laryngitis

Study Overview

• Status: Completed
• Conditions: Pharyngitis
• Intervention / Treatment: Drug: Diclofenac; Drug: Meloxicam; Drug: Nimesulide

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients of both genders between 2 and 8 years old

• Outpatients, with onset of symptoms not more than 72 hours prior to presentation, patients with acute non-bacterial pharyngitis or pharyngotonsillitis diagnosed according to the following criteria:

  • Spontaneous pharyngeal pain, pharyngeal pain upon swallowing, pharyngeal and/or tonsillar hyperemia, absence of purulent plaques, pharyngeal smear negative for ß-hemolytic Streptococcus or Strepto Test® and Treatment with an Non-steroidal anti-inflammatory drugs (NSAID) required or recommended

Exclusion Criteria:

• Known or suspected hypersensitivity to study medications or NSAID's
• Pharyngeal smear positive for ß-hemolytic Streptococcus
• treatment with antimicrobials prior to enrolment in the study
• Chronic infection, infectious mononucleosis, peptic ulcer disease that has been active in the previous 6 months
• Asthma
• nasal polyps
• angioneurotic edema or urticaria after the administration of aspirin or NSAID's
• Concomitant treatment with anticoagulants (including heparin), lithium or methotrexate
• Concomitant administration of other NSAID's (including high dose aspirin) or analgesics, except authorized rescue drugs
• Administration of any NSAID during the three previous days or of analgesics within six hours prior to the administration of the first study drug dose
• Treatment with corticosteroids at the time of enrollment or within the two previous months
• Known liver, renal or hematological disease
• Participation in another clinical trial during the study period or during the previous month
• Previous enrollment in this study
• Inability to comply with the protocol

• Suspected acute bacterial pharyngitis or pharyngotonsillitis (under the following clinical criteria):

  • Clinical presentation characterized by a rapid onset, very high fever (>38.5°C), severe pharyngeal pain, cervical adenopathy, intense headache, purulent pharyngeal plaques, evidence of peritonsillar abscess or phlegmon

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meloxicam suspension	Drug: Meloxicam
Active Comparator: Diclofenac suspension	Drug: Diclofenac
Active Comparator: Nimesulide suspension	Drug: Nimesulide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in spontaneous pharyngeal pain	baseline, 5 days
Change in pharyngeal pain on deglutition (dysphagia)	baseline, 5 days
Change in pharyngeal hyperemia	baseline, 5 days
Change in systemic manifestations (fever, adenomegaly and general malaise)	baseline, 5 days
Incidence of adverse events	baseline, 5 days

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: August 1, 2001
• Primary Completion (Actual): February 1, 2002

Study Registration Dates

• First Submitted: August 28, 2014
• First Submitted That Met QC Criteria: August 29, 2014
• First Posted (Estimate): September 1, 2014

Study Record Updates

• Last Update Posted (Estimate): September 1, 2014
• Last Update Submitted That Met QC Criteria: August 29, 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; Laryngeal Diseases; Pharyngitis; Laryngitis; 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; Diclofenac; Meloxicam; Nimesulide
• Other Study ID Numbers: 107.250