<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/NCT02262702</url>
  </required_header>
  <id_info>
    <org_study_id>202175</org_study_id>
    <secondary_id>RH01690</secondary_id>
    <nct_id>NCT02262702</nct_id>
  </id_info>
  <brief_title>Panadol Osteo Pharmaceuticals Benefit Scheme (PBS) Claims Cohort Study</brief_title>
  <official_title>Panadol Osteo PBS Claims Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this observational study is to compare the use of an extended release paracetamol&#xD;
      formulation with standard paracetamol in a cohort of Australian concessional patients with&#xD;
      osteoarthritis (OA), to assess differences in prescribing patterns and patient compliance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This retrospective analysis of physician prescribing data (long-term concessional cohort from&#xD;
      the Medicare Australia PBS claims dataset for the time period 2008-2011 (4 years) will&#xD;
      compare the use of extended release paracetamol (Panadol Osteo) with standard paracetamol&#xD;
      500mg in a cohort of Australian concessional patients with OA, to assess differences in&#xD;
      prescribing patterns and patient compliance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</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>Relative number of prescriptions of an extended release paracetamol formulation and a standard release paracetamol formulation.</measure>
    <time_frame>January 2009 to December 2010</time_frame>
    <description>Number of episodes of treatment for OA with the extended release formulation and the standard release formulatins will be counted.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Relative treatment compliance with an extended release paracetamol formulation and a standard release paracetamol formulation</measure>
    <time_frame>January 2009 to December 2010</time_frame>
    <description>Interval between the repeat doses of extended release paracetamol formulation and the standard release paracetamol formulation.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Extended Release Paracetamol</arm_group_label>
    <description>Participants prescribed with extended release paracetamol tablet containing 665 mg paracetamol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Paracetamol</arm_group_label>
    <description>Participants prescribed with standard paracetamol tablet containing 500 mg paracetamol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paracetamol 665 mg</intervention_name>
    <description>Paracetamol 665 mg tablet</description>
    <arm_group_label>Extended Release Paracetamol</arm_group_label>
    <other_name>Panadol Osteo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paracetamol 500 mg</intervention_name>
    <description>Paracetamol 500 mg tablet</description>
    <arm_group_label>Standard Paracetamol</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Cohort of Australian concessional patients with osteoarthritis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants prescribed with a paracetamol product and categorized as a concessional&#xD;
             patient&#xD;
&#xD;
          -  Participants with new episodes of OA (no history of OA paracetamol in previous 12&#xD;
             months) or suffering from chronic OA (history of OA paracetamol in the previous 12&#xD;
             months)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with Rheumatoid arthritis or other auto-immune inflammatory conditions&#xD;
&#xD;
          -  Participants receiving the following anti-rheumatoid therapies:Immunimodulators such&#xD;
             as methotrexate, leflunamide and TNF blockers&#xD;
&#xD;
          -  Participants receiving treatment for cancer pain&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>May 23, 2013</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>January 21, 2016</last_update_submitted>
  <last_update_submitted_qc>January 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 2016</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>Osteoarthritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</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/NCT02262702
org study id: 202175
secondary id: RH01690
nct id: NCT02262702
lead sponsor: 
has dmc: No
The aim of this observational study is to compare the use of an extended release paracetamol
      formulation with standard paracetamol in a cohort of Australian concessional patients with
      osteoarthritis (OA), to assess differences in prescribing patterns and patient compliance.
This retrospective analysis of physician prescribing data (long-term concessional cohort from
      the Medicare Australia PBS claims dataset for the time period 2008-2011 (4 years) will
      compare the use of extended release paracetamol (Panadol Osteo) with standard paracetamol
      500mg in a cohort of Australian concessional patients with OA, to assess differences in
      prescribing patterns and patient compliance.
observational model: Cohort
time perspective: Retrospective
measure: Relative number of prescriptions of an extended release paracetamol formulation and a standard release paracetamol formulation.
time frame: January 2009 to December 2010
description: Number of episodes of treatment for OA with the extended release formulation and the standard release formulatins will be counted.
measure: Relative treatment compliance with an extended release paracetamol formulation and a standard release paracetamol formulation
time frame: January 2009 to December 2010
description: Interval between the repeat doses of extended release paracetamol formulation and the standard release paracetamol formulation.
arm group label: Extended Release Paracetamol
description: Participants prescribed with extended release paracetamol tablet containing 665 mg paracetamol.
arm group label: Standard Paracetamol
description: Participants prescribed with standard paracetamol tablet containing 500 mg paracetamol.
intervention type: Drug
intervention name: Paracetamol 665 mg
description: Paracetamol 665 mg tablet
arm group label: Extended Release Paracetamol
other name: Panadol Osteo
intervention type: Drug
intervention name: Paracetamol 500 mg
description: Paracetamol 500 mg tablet
arm group label: Standard Paracetamol
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Acetaminophen