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

Phase 4

Completed

• Conditions: Pharyngitis
• Interventions: Drug: Meloxicam; Drug: Nimesulide; Drug: Diclofenac

• Registration Number: NCT02229747
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-08
• Primary Completion: 2002-02
• Status Verified: 2014-07
• Study First Submitted: 2014-08-28
• Study First Submitted QC: 2014-08-29
• Last Update Submitted: 2014-08-29
• Study First Posted: 2014-09-01
• Last Update Posted: 2014-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Meloxicam suspension	Meloxicam	-
Nimesulide suspension	Nimesulide	-
Diclofenac suspension	Diclofenac	-

Primary Outcome Measures

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