<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/NCT01710917</url>
  </required_header>
  <id_info>
    <org_study_id>OXN9512</org_study_id>
    <nct_id>NCT01710917</nct_id>
  </id_info>
  <brief_title>A Non-interventional, Observational Study for Quality of Life (Overall Health Assessment) in Patients With Chronic Severe Pain During Targinact® Treatment</brief_title>
  <official_title>The Efficacy of Targinact® Treatment With Respect to Quality of Life (Overall Health Assessment) in Chronic Severe Pain Patients Compared to Previous Analgesic 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 evaluates the efficacy of Targinact with regard&#xD;
      to quality of life in daily clinical practice in Belgium compared to the previous analgesic&#xD;
      treatment.&#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 overall health&#xD;
      assessment of the patient, pain relief, constipation, use of laxatives, use of analgesic&#xD;
      rescue medication, use of concomitant medication, quality of life and safety of Targinact®&#xD;
      treatment. These parameters, except for safety assessment, are compared between Targinact®&#xD;
      treatment and previous analgesic treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">January 2014</completion_date>
  <primary_completion_date type="Anticipated">November 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>Assess the efficacy of Targinact® treatment</measure>
    <time_frame>12 weeks</time_frame>
    <description>The primary parameter to assess the efficacy of Targinact® treatment with respect to the quality of life (overall health assessment/EQ-VAS) in patients with chronic severe pain compared to previous analgesic treatment is the absolute change in overall health score (0-100) attributed by patients during Targinact® treatment compared to previous analgesic treatment.&#xD;
During each visit, patients will be asked to score their overall health state between 0 (worst health state imaginable) and 100 (best health state imaginable). The absolute changes in overall health assessment from baseline at V2 and V3 will be used to compare health assessment during Targinact® treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>• To assess pain (NRS) during Targinact® treatment compared to previous analgesic treatment (by physician)</measure>
    <time_frame>12 weeks</time_frame>
    <description>To assess pain (NRS) during Targinact® treatment compared to previous analgesic treatment (by physician)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess constipation (BFI) during Targinact® treatment compared to previous analgesic treatment (by physician)</measure>
    <time_frame>12 weeks</time_frame>
    <description>To assess constipation (BFI) during Targinact® treatment compared to previous analgesic treatment (by physician)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess laxative use during Targinact® treatment compared to previous analgesic treatment (by physician)</measure>
    <time_frame>12 weeks</time_frame>
    <description>To assess laxative use during Targinact® treatment compared to previous analgesic treatment (by physician)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess the use of analgesic rescue medication during Targinact® treatment compared to previous analgesic 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 analgesic treatment (by physician)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous analgesic 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 analgesic 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>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1800</enrollment>
  <condition>Chronic Severe Pain</condition>
  <arm_group>
    <arm_group_label>Targinact® (oxycodon/naloxon)</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Targinact® (oxycodon/naloxon)</intervention_name>
    <arm_group_label>Targinact® (oxycodon/naloxon)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Primary and Secondary care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        Patients enrolled in the study are patients who&#xD;
&#xD;
          -  are eligible for Targinact® treatment according to the Targinact® SPC AND&#xD;
&#xD;
          -  who have previously been treated with WHO step 1, 2 or 3 analgesics&#xD;
&#xD;
        Exclusion criteria are based on the 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>
  <overall_contact>
    <last_name>Maggie C Wilson</last_name>
    <email>Info@contact-clinical-trials.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jill Kiteley</last_name>
    <email>Info@contact-clinical-trials.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital Brussels (UZ Brussel), Belgium</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>October 15, 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>November 11, 2013</last_update_submitted>
  <last_update_submitted_qc>November 11, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 13, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic pain</keyword>
  <keyword>Severe pain</keyword>
  <keyword>Oxycodon</keyword>
  <keyword>Naloxon</keyword>
  <keyword>Opioid-induced constipation</keyword>
  <keyword>Opioid</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Laxative</keyword>
  <keyword>Analgesic rescue medication</keyword>
  <!-- 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/NCT01710917
org study id: OXN9512
nct id: NCT01710917
lead sponsor: 
This non-interventional, observational study evaluates the efficacy of Targinact with regard
      to quality of life in daily clinical practice in Belgium compared to the previous analgesic
      treatment.
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 overall health
      assessment of the patient, 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.
observational model: Cohort
time perspective: Prospective
measure: Assess the efficacy of Targinact® treatment
time frame: 12 weeks
description: The primary parameter to assess the efficacy of Targinact® treatment with respect to the quality of life (overall health assessment/EQ-VAS) in patients with chronic severe pain compared to previous analgesic treatment is the absolute change in overall health score (0-100) attributed by patients during Targinact® treatment compared to previous analgesic treatment.
During each visit, patients will be asked to score their overall health state between 0 (worst health state imaginable) and 100 (best health state imaginable). The absolute changes in overall health assessment from baseline at V2 and V3 will be used to compare health assessment during Targinact® treatment.
measure: • To assess pain (NRS) during Targinact® treatment compared to previous analgesic treatment (by physician)
time frame: 12 weeks
description: To assess pain (NRS) during Targinact® treatment compared to previous analgesic treatment (by physician)
measure: To assess constipation (BFI) during Targinact® treatment compared to previous analgesic treatment (by physician)
time frame: 12 weeks
description: To assess constipation (BFI) during Targinact® treatment compared to previous analgesic treatment (by physician)
measure: To assess laxative use during Targinact® treatment compared to previous analgesic treatment (by physician)
time frame: 12 weeks
description: To assess laxative use during Targinact® treatment compared to previous analgesic treatment (by physician)
measure: To assess the use of analgesic rescue medication during Targinact® treatment compared to previous analgesic treatment (by physician)
time frame: 12 weeks
description: To assess the use of analgesic rescue medication during Targinact® treatment compared to previous analgesic treatment (by physician)
measure: To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous analgesic treatment (by patient)
time frame: 12 weeks
description: To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous analgesic 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.
arm group label: Targinact® (oxycodon/naloxon)
intervention type: Drug
intervention name: Targinact® (oxycodon/naloxon)
arm group label: Targinact® (oxycodon/naloxon)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maggie C Wilson
email: Info@contact-clinical-trials.com
last name: Jill Kiteley
email: Info@contact-clinical-trials.com
facility: 
status: Recruiting
country: Belgium
responsible party type: Sponsor