<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/NCT02184039</url>
  </required_header>
  <id_info>
    <org_study_id>107.264</org_study_id>
    <nct_id>NCT02184039</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Meloxicam (Mobicox®) in Mexican Population With Rheumatic Diseases</brief_title>
  <official_title>Clinical Therapeutic Evaluation Program in Patients With Rheumatic Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to evaluate the efficacy and safety of meloxicam (Mobicox®) in Mexican population with&#xD;
      rheumatic diseases.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2003</start_date>
  <primary_completion_date type="Actual">July 2004</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in intensity of the symptoms measured with a four-point scale</measure>
    <time_frame>Baseline, 30 and 90 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Degree of satisfaction evaluated with a six point numerical rating scale</measure>
    <time_frame>up to 90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 90 days</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">12687</enrollment>
  <condition>Osteoarthritis</condition>
  <eligibility>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypersensitivity to meloxicam or to other NSAIDS&#xD;
&#xD;
          -  History of asthma, angioedema or urticaria secondary to NSAIDS&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Recent or current history of peptic ulcer disease, severe renal failure, severe&#xD;
             hepatic failure&#xD;
&#xD;
          -  Age below of 12 years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/107/107.264_U11-3131-01.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>July 8, 2014</last_update_submitted>
  <last_update_submitted_qc>July 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 9, 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>Rheumatic Diseases</mesh_term>
    <mesh_term>Collagen Diseases</mesh_term>
  </condition_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/NCT02184039
org study id: 107.264
nct id: NCT02184039
lead sponsor: 
Study to evaluate the efficacy and safety of meloxicam (Mobicox®) in Mexican population with
      rheumatic diseases.
observational model: Cohort
time perspective: Prospective
measure: Change in intensity of the symptoms measured with a four-point scale
time frame: Baseline, 30 and 90 days
measure: Degree of satisfaction evaluated with a six point numerical rating scale
time frame: up to 90 days
measure: Number of patients with adverse events
time frame: up to 90 days
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/107/107.264_U11-3131-01.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Rheumatic Diseases
mesh term: Collagen Diseases