<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/NCT01710904</url>
  </required_header>
  <id_info>
    <org_study_id>OXN9511</org_study_id>
    <nct_id>NCT01710904</nct_id>
  </id_info>
  <brief_title>A Non-interventional, Observational Study for Targinact® Treatment in Patients With Chronic Severe Pain</brief_title>
  <official_title>The Evaluation of Targinact® in Daily Practice, With Regards to Pain Relief and Constipation, in Chronic Severe Pain Patients Compared to Previous Prolonged Release Oxycodone Treatment: a Non-interventional, Observational Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mundipharma CVA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mundipharma CVA</source>
  <brief_summary>
    <textblock>
      This non-interventional, observational study is set up on request of the Belgian&#xD;
      reimbursement authorities and evaluates the efficacy of Targinact with regard to pain relief&#xD;
      and constipation in daily clinical practice in Belgium compared to the previous analgesic&#xD;
      treatment with prolonged release oxycodone. Only patients eligible for Targinact®&#xD;
      reimbursement in Belgium are included.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients are treated with Targinact® according to daily clinical practice during at least 12&#xD;
      weeks and are monitored during study 3 visits. Parameters assessed are pain relief,&#xD;
      constipation, use of laxatives, use of analgesic rescue medication, use of concomitant&#xD;
      medication, quality of life and safety of Targinact® treatment. These parameters, except for&#xD;
      safety assessment, are compared between Targinact® treatment and previous analgesic treatment&#xD;
      with prolonged release oxycodone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">July 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of responders after Targinact treatment compared to the previous treatment with prolonged release oxycodone.</measure>
    <time_frame>12 weeks</time_frame>
    <description>A responder is defined as a patient who shows no worsening of pain (pain score has increased ≤ 1 unit on a 11-points pain NRS) at V3/the last visit compared to V1 or has a NRS ≤4 on a 11-points pain NRS at V3/the last visit AND has a reduction in BFI ≥ 12 units at V3/the last visit compared to V1 or has a BFI ≤30 at V3/ the last visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To assess laxative use during Targinact® treatment compared to previous PR oxycodone treatment (by physician)</measure>
    <time_frame>12 weeks</time_frame>
    <description>To assess laxative use during Targinact® treatment compared to previous PR oxycodone treatment (by physician)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess the use of analgesic rescue medication during Targinact® treatment compared to previous PR oxycodone treatment (by physician)</measure>
    <time_frame>12 weeks</time_frame>
    <description>To assess the use of analgesic rescue medication during Targinact® treatment compared to previous PR oxycodone treatment (by physician)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous PR oxycodone treatment (by patient)</measure>
    <time_frame>12 weeks</time_frame>
    <description>To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous PR oxycodone treatment (by patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess safety of Targinact® treatment (by physician)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Safety will be assessed by documentation of adverse events, collected via spontaneous reports and patient documentation.</description>
  </secondary_outcome>
  <enrollment type="Actual">68</enrollment>
  <condition>Chronic Severe Pain</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Targinact® (oxycodone/naloxone)</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Primary and Secondary Care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria: patients included are patients who&#xD;
&#xD;
          -  are eligible for Targinact® treatment according to the Targinact® SPC AND&#xD;
&#xD;
          -  who have previously been treated with PR oxycodone during at least the last 30 days&#xD;
             before study inclusion AND&#xD;
&#xD;
          -  who are constipated (BFI &gt; 30) AND&#xD;
&#xD;
          -  have used at least 2 laxatives with different modes of action during the previous PR&#xD;
             oxycodone treatment&#xD;
&#xD;
        Exclusion criteria are based on Targinact® SPC.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital Brussels</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>http://dx.doi.org/10.1016/j.clinthera.2015.02.010</url>
    <description>Clinical Therapeutics</description>
  </link>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>April 7, 2015</last_update_submitted>
  <last_update_submitted_qc>April 7, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic pain</keyword>
  <keyword>Severe pain</keyword>
  <keyword>Oxycodone</keyword>
  <keyword>Naloxone</keyword>
  <keyword>Opioid-induced constipation</keyword>
  <keyword>Opioid</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Laxative</keyword>
  <keyword>Analgesic rescue medication</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxycodone</mesh_term>
    <mesh_term>Naloxone</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/NCT01710904
org study id: OXN9511
nct id: NCT01710904
lead sponsor: 
This non-interventional, observational study is set up on request of the Belgian
      reimbursement authorities and evaluates the efficacy of Targinact with regard to pain relief
      and constipation in daily clinical practice in Belgium compared to the previous analgesic
      treatment with prolonged release oxycodone. Only patients eligible for Targinact®
      reimbursement in Belgium are included.
Patients are treated with Targinact® according to daily clinical practice during at least 12
      weeks and are monitored during study 3 visits. Parameters assessed are pain relief,
      constipation, use of laxatives, use of analgesic rescue medication, use of concomitant
      medication, quality of life and safety of Targinact® treatment. These parameters, except for
      safety assessment, are compared between Targinact® treatment and previous analgesic treatment
      with prolonged release oxycodone.
observational model: Cohort
time perspective: Prospective
measure: Percentage of responders after Targinact treatment compared to the previous treatment with prolonged release oxycodone.
time frame: 12 weeks
description: A responder is defined as a patient who shows no worsening of pain (pain score has increased ≤ 1 unit on a 11-points pain NRS) at V3/the last visit compared to V1 or has a NRS ≤4 on a 11-points pain NRS at V3/the last visit AND has a reduction in BFI ≥ 12 units at V3/the last visit compared to V1 or has a BFI ≤30 at V3/ the last visit.
measure: To assess laxative use during Targinact® treatment compared to previous PR oxycodone treatment (by physician)
time frame: 12 weeks
description: To assess laxative use during Targinact® treatment compared to previous PR oxycodone treatment (by physician)
measure: To assess the use of analgesic rescue medication during Targinact® treatment compared to previous PR oxycodone treatment (by physician)
time frame: 12 weeks
description: To assess the use of analgesic rescue medication during Targinact® treatment compared to previous PR oxycodone treatment (by physician)
measure: To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous PR oxycodone treatment (by patient)
time frame: 12 weeks
description: To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous PR oxycodone treatment (by patient)
measure: To assess safety of Targinact® treatment (by physician)
time frame: 12 weeks
description: Safety will be assessed by documentation of adverse events, collected via spontaneous reports and patient documentation.
intervention type: Drug
intervention name: Targinact® (oxycodone/naloxone)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Belgium
url: http://dx.doi.org/10.1016/j.clinthera.2015.02.010
description: Clinical Therapeutics
responsible party type: Sponsor
mesh term: Oxycodone
mesh term: Naloxone