<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/NCT01685424</url>
  </required_header>
  <id_info>
    <org_study_id>0663-162</org_study_id>
    <secondary_id>7013.021</secondary_id>
    <secondary_id>EMEA/H/A - 31/632</secondary_id>
    <nct_id>NCT01685424</nct_id>
  </id_info>
  <brief_title>Etoricoxib Prescribing Patterns and Adverse Events of Interest in Primary Care in the United Kingdom (MK-0663-162 AM1)</brief_title>
  <official_title>Etoricoxib Prescribing Patterns and Adverse Events of Interest During Etoricoxib Treatment in UK Primary Care; an Updated Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Organon and Co</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Organon and Co</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This postmarketing study was conducted to describe prescribing patterns for etoricoxib&#xD;
      (ARCOXIA®) in General Practice and describe the incidence of selected adverse events recorded&#xD;
      in the United Kingdom (UK) Medicines and Health Care Products Regulatory Agency (MHRA)&#xD;
      General Practice Research Database (GPRD).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2006</start_date>
  <completion_date type="Actual">March 1, 2015</completion_date>
  <primary_completion_date type="Actual">March 1, 2015</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Dose of Initial Etoricoxib Prescription</measure>
    <time_frame>At first prescription (during a time period up to 13.75 years)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of Initial Etoricoxib Prescription</measure>
    <time_frame>At first prescription (during a time period up to 13.75 years)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Participant's Baseline Characteristics (Demographics and Medical)</measure>
    <time_frame>At first prescription (during a time period up to 13.75 years)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Adverse Events of Special Interest Among Etoricoxib Users</measure>
    <time_frame>During a time period up to 13.75 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>&quot;Off-label&quot; use of Etoricoxib</measure>
    <time_frame>At first prescription (during a time period up to 13.75 years)</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">79189</enrollment>
  <condition>Osteoarthritis</condition>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Ankylosing Spondylitis</condition>
  <condition>Gout</condition>
  <condition>Arthritis</condition>
  <arm_group>
    <arm_group_label>Etoricoxib Prescription (Period 1)</arm_group_label>
    <description>First Etoricoxib Prescription, Apr. 1, 2002 to Feb. 17, 2005</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Etoricoxib Prescription (Period 2)</arm_group_label>
    <description>First Etoricoxib Prescription, Feb. 18, 2005 to Dec. 31, 2015</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Repeat Etoricoxib Prescription</arm_group_label>
    <description>One prescription during the Period 1 and, at least, one etoricoxib prescription during Period 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etoricoxib</intervention_name>
    <description>As per routine clinical practice in the United Kingdom</description>
    <arm_group_label>Etoricoxib Prescription (Period 1)</arm_group_label>
    <arm_group_label>Etoricoxib Prescription (Period 2)</arm_group_label>
    <arm_group_label>Repeat Etoricoxib Prescription</arm_group_label>
    <other_name>ARCOXIA®)</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All participants in the MHRA's Full Feature GPRD (FF-GPRD) who have at least one electronic&#xD;
        outpatient prescription record for etoricoxib issued by a General Practitioner during the&#xD;
        period (April 1, 2002 to December 31, 2015) at the date of query execution against the&#xD;
        FF-GPRD data warehouse.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients in the MHRA's Full Feature GPRD (FF-GPRD) who have at least one&#xD;
             electronic outpatient prescription record for etoricoxib issued by a General&#xD;
             Practitioner during the period (April 1, 2002 to December 31, 2015) at the date of&#xD;
             query execution against the FF-GPRD data warehouse.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not registered in a GPRD-contributing practice that had continuously&#xD;
&#xD;
        collected data deemed to be 'up-to-standard' for research purposes from 1 April 2002&#xD;
        through to 31 December 2015.&#xD;
&#xD;
          -  Never registered as a permanent patient of a General Practitioner in the practice&#xD;
&#xD;
          -  Registration details were not acceptable (i.e. incomplete data or logically&#xD;
             implausible dates)&#xD;
&#xD;
          -  Not registered with a General Practitioner for at least 365 days before the date that&#xD;
             the patient's first etoricoxib prescription was recorded in the GPRD&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <link>
    <url>http://www.encepp.eu/encepp/viewResource.htm?id=19307</url>
    <description>EU PAS Register (EUPAS17526)</description>
  </link>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>February 7, 2022</last_update_submitted>
  <last_update_submitted_qc>February 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Etoricoxib</keyword>
  <keyword>ARCOXIA</keyword>
  <keyword>Osteoarthritis</keyword>
  <keyword>Rheumatoid Arthritis</keyword>
  <keyword>Ankylosing Spondylitis</keyword>
  <keyword>Gout</keyword>
  <keyword>Arthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
    <mesh_term>Spondylitis, Ankylosing</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Etoricoxib</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/NCT01685424
org study id: 0663-162
secondary id: 7013.021
secondary id: EMEA/H/A - 31/632
nct id: NCT01685424
lead sponsor: 
has dmc: No
This postmarketing study was conducted to describe prescribing patterns for etoricoxib
      (ARCOXIA®) in General Practice and describe the incidence of selected adverse events recorded
      in the United Kingdom (UK) Medicines and Health Care Products Regulatory Agency (MHRA)
      General Practice Research Database (GPRD).
observational model: Cohort
time perspective: Retrospective
measure: Dose of Initial Etoricoxib Prescription
time frame: At first prescription (during a time period up to 13.75 years)
measure: Duration of Initial Etoricoxib Prescription
time frame: At first prescription (during a time period up to 13.75 years)
measure: Participant's Baseline Characteristics (Demographics and Medical)
time frame: At first prescription (during a time period up to 13.75 years)
measure: Incidence of Adverse Events of Special Interest Among Etoricoxib Users
time frame: During a time period up to 13.75 years
measure: "Off-label" use of Etoricoxib
time frame: At first prescription (during a time period up to 13.75 years)
arm group label: Etoricoxib Prescription (Period 1)
description: First Etoricoxib Prescription, Apr. 1, 2002 to Feb. 17, 2005
arm group label: Etoricoxib Prescription (Period 2)
description: First Etoricoxib Prescription, Feb. 18, 2005 to Dec. 31, 2015
arm group label: Repeat Etoricoxib Prescription
description: One prescription during the Period 1 and, at least, one etoricoxib prescription during Period 2.
intervention type: Drug
intervention name: Etoricoxib
description: As per routine clinical practice in the United Kingdom
arm group label: Etoricoxib Prescription (Period 1)
arm group label: Etoricoxib Prescription (Period 2)
arm group label: Repeat Etoricoxib Prescription
other name: ARCOXIA®)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
country: United States
url: http://www.encepp.eu/encepp/viewResource.htm?id=19307
description: EU PAS Register (EUPAS17526)
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Arthritis
mesh term: Osteoarthritis
mesh term: Arthritis, Rheumatoid
mesh term: Spondylarthritis
mesh term: Spondylitis, Ankylosing
mesh term: Etoricoxib