<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02229747</url>
  </required_header>
  <id_info>
    <org_study_id>107.250</org_study_id>
    <nct_id>NCT02229747</nct_id>
  </id_info>
  <brief_title>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</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The objective of this study was to assess the clinical efficacy and safety of meloxicam&#xD;
      suspension 0.25 mg/kg/day once a day, versus diclofenac suspension 1 mg/kg/day twice a day or&#xD;
      nimesulide suspension 4 mg/kg/day twice a day, after five days of treatment in patients with&#xD;
      a diagnosis of acute, non-bacterial pharyngitis, pharyngotonsillitis or laryngitis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2001</start_date>
  <primary_completion_date type="Actual">February 2002</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in spontaneous pharyngeal pain</measure>
    <time_frame>baseline, 5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in pharyngeal pain on deglutition (dysphagia)</measure>
    <time_frame>baseline, 5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in pharyngeal hyperemia</measure>
    <time_frame>baseline, 5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in systemic manifestations (fever, adenomegaly and general malaise)</measure>
    <time_frame>baseline, 5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>baseline, 5 days</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Pharyngitis</condition>
  <arm_group>
    <arm_group_label>Meloxicam suspension</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Diclofenac suspension</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Nimesulide suspension</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Meloxicam</intervention_name>
    <arm_group_label>Meloxicam suspension</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diclofenac</intervention_name>
    <arm_group_label>Diclofenac suspension</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nimesulide</intervention_name>
    <arm_group_label>Nimesulide suspension</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of both genders between 2 and 8 years old&#xD;
&#xD;
          -  Outpatients, with onset of symptoms not more than 72 hours prior to presentation,&#xD;
             patients with acute non-bacterial pharyngitis or pharyngotonsillitis diagnosed&#xD;
             according to the following criteria:&#xD;
&#xD;
               -  Spontaneous pharyngeal pain, pharyngeal pain upon swallowing, pharyngeal and/or&#xD;
                  tonsillar hyperemia, absence of purulent plaques, pharyngeal smear negative for&#xD;
                  ß-hemolytic Streptococcus or Strepto Test® and Treatment with an Non-steroidal&#xD;
                  anti-inflammatory drugs (NSAID) required or recommended&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or suspected hypersensitivity to study medications or NSAID's&#xD;
&#xD;
          -  Pharyngeal smear positive for ß-hemolytic Streptococcus&#xD;
&#xD;
          -  treatment with antimicrobials prior to enrolment in the study&#xD;
&#xD;
          -  Chronic infection, infectious mononucleosis, peptic ulcer disease that has been active&#xD;
             in the previous 6 months&#xD;
&#xD;
          -  Asthma&#xD;
&#xD;
          -  nasal polyps&#xD;
&#xD;
          -  angioneurotic edema or urticaria after the administration of aspirin or NSAID's&#xD;
&#xD;
          -  Concomitant treatment with anticoagulants (including heparin), lithium or methotrexate&#xD;
&#xD;
          -  Concomitant administration of other NSAID's (including high dose aspirin) or&#xD;
             analgesics, except authorized rescue drugs&#xD;
&#xD;
          -  Administration of any NSAID during the three previous days or of analgesics within six&#xD;
             hours prior to the administration of the first study drug dose&#xD;
&#xD;
          -  Treatment with corticosteroids at the time of enrollment or within the two previous&#xD;
             months&#xD;
&#xD;
          -  Known liver, renal or hematological disease&#xD;
&#xD;
          -  Participation in another clinical trial during the study period or during the previous&#xD;
             month&#xD;
&#xD;
          -  Previous enrollment in this study&#xD;
&#xD;
          -  Inability to comply with the protocol&#xD;
&#xD;
          -  Suspected acute bacterial pharyngitis or pharyngotonsillitis (under the following&#xD;
             clinical criteria):&#xD;
&#xD;
               -  Clinical presentation characterized by a rapid onset, very high fever (&gt;38.5°C),&#xD;
                  severe pharyngeal pain, cervical adenopathy, intense headache, purulent&#xD;
                  pharyngeal plaques, evidence of peritonsillar abscess or phlegmon&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/107/107.250_U11-3428-01.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <last_update_submitted>August 29, 2014</last_update_submitted>
  <last_update_submitted_qc>August 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharyngitis</mesh_term>
    <mesh_term>Laryngitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diclofenac</mesh_term>
    <mesh_term>Meloxicam</mesh_term>
    <mesh_term>Nimesulide</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02229747
org study id: 107.250
nct id: NCT02229747
lead sponsor: 
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in spontaneous pharyngeal pain
time frame: baseline, 5 days
measure: Change in pharyngeal pain on deglutition (dysphagia)
time frame: baseline, 5 days
measure: Change in pharyngeal hyperemia
time frame: baseline, 5 days
measure: Change in systemic manifestations (fever, adenomegaly and general malaise)
time frame: baseline, 5 days
measure: Incidence of adverse events
time frame: baseline, 5 days
arm group label: Meloxicam suspension
arm group type: Experimental
arm group label: Diclofenac suspension
arm group type: Active Comparator
arm group label: Nimesulide suspension
arm group type: Active Comparator
intervention type: Drug
intervention name: Meloxicam
arm group label: Meloxicam suspension
intervention type: Drug
intervention name: Diclofenac
arm group label: Diclofenac suspension
intervention type: Drug
intervention name: Nimesulide
arm group label: Nimesulide suspension
criteria: 
gender: All
minimum age: 2 Years
maximum age: 8 Years
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/107/107.250_U11-3428-01.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Pharyngitis
mesh term: Laryngitis
mesh term: Diclofenac
mesh term: Meloxicam
mesh term: Nimesulide