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OpenTrials
Completed

NCT Number: NCT02229747

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

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

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Key information

Age range

2 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meloxicam

Drug

Diclofenac

Drug

Nimesulide

Drug

Primary outcomes

  1. Change in spontaneous pharyngeal pain

    Time frame: baseline, 5 days

  2. Change in pharyngeal pain on deglutition (dysphagia)

    Time frame: baseline, 5 days

  3. Change in pharyngeal hyperemia

    Time frame: baseline, 5 days

  4. Change in systemic manifestations (fever, adenomegaly and general malaise)

    Time frame: baseline, 5 days

  5. Incidence of adverse events

    Time frame: baseline, 5 days

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2002
First posted
Sep 1, 2014
Registry last updated
Sep 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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