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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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02229747
Recruitment Status : Completed
First Posted : September 1, 2014
Last Update Posted : September 1, 2014
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Pharyngitis Drug: Meloxicam Drug: Diclofenac Drug: Nimesulide Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : August 2001
Actual Primary Completion Date : February 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

Arm Intervention/treatment
Experimental: Meloxicam suspension Drug: Meloxicam
Active Comparator: Diclofenac suspension Drug: Diclofenac
Active Comparator: Nimesulide suspension Drug: Nimesulide

Primary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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Responsible Party: Boehringer Ingelheim Identifier: NCT02229747    
Other Study ID Numbers: 107.250
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Laryngeal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors