<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/NCT03814993</url>
  </required_header>
  <id_info>
    <org_study_id>PLATINUM</org_study_id>
    <nct_id>NCT03814993</nct_id>
  </id_info>
  <brief_title>taPentadol cLinical prAcTice IN belgiUM</brief_title>
  <acronym>PLATINUM</acronym>
  <official_title>Multicenter Observational Study to Determine the Long-term Tolerability and Analgesic Effectiveness of Oral Tapentadol in Patients Suffering From Severe Pain Syndromes, Refractory to Other Strong Opioids.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dafne Balemans</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Grünenthal GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Antwerp</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multicenter observational study to determine the long-term tolerability and analgesic&#xD;
      effectiveness of oral tapentadol in patients suffering from severe pain syndromes, refractory&#xD;
      to other strong opioids.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tapentadol, a centrally acting analgesic. It is indicated in Europe &quot;for the relief of&#xD;
      moderate to severe acute pain in adults, which can be adequately managed only with opioid&#xD;
      analgesics&quot; (IR formulation/oral solution) and &quot;for the management of severe chronic pain in&#xD;
      adults, which can be adequately managed only with opioid analgesics&quot; (SR formulation).&#xD;
      Tapentadol is reimbursed in Belgium since May 1, 2018. The reimbursement was obtained through&#xD;
      an article 81 procedure (Chapter IV) which means that the reimbursement is currently&#xD;
      restricted to the time frame of the contract and that during that period certain questions&#xD;
      and uncertainties regarding the use of tapentadol in a Belgian setting need to be answered.&#xD;
      In order to answer the questions raised by the Belgian Healthcare authorities, this study&#xD;
      will be performed evaluating the application of oral tapentadol in routine clinical practice&#xD;
      in Belgium. The study is conceived as a nation-wide multicentre prospective&#xD;
      non-interventional trial. The primary endpoint and secondary endpoints of this study are&#xD;
      guided by the questions that need to be answered during the course of the contract&#xD;
      reimbursement, as established by the Belgian health authorities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 29, 2019</start_date>
  <completion_date type="Actual">August 1, 2021</completion_date>
  <primary_completion_date type="Actual">August 1, 2021</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>Difference in occurrence of gastrointestinal side effects (nausea, vomiting and constipation) between baseline and week 15</measure>
    <time_frame>baseline - week 15</time_frame>
    <description>Differences in occurence of the PRO-CTCAE items: Nausea, vomiting and constipation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in frequency, severity and interference of selected side effects (dizziness, fatigue, itching, headache, dry mouth, nausea, vomiting, constipation) from baseline to week 52</measure>
    <time_frame>baseline - week 52</time_frame>
    <description>Difference in frequency, severity and interference of selected PRO-CTCAE items</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pain Scores on the Numeric Rating Scale baseline to different time points during long-term follow-up</measure>
    <time_frame>baseline - week 52</time_frame>
    <description>Reduction in pain intensity numeric rating scale (PI-NRS). Scale: 0 = no pain and 10 = worst possible pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of health-related quality of life from baseline to different time points during long-term follow-up</measure>
    <time_frame>baseline - week 52</time_frame>
    <description>Change of healt-related quality of life measured by EQ-5D-5L (monthly evaluation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of health-related quality of life from baseline to different time points during long-term follow-up</measure>
    <time_frame>baseline - week 52</time_frame>
    <description>Change of healt-related quality of life measured SF-36 (monthly evaluation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of functional status of the patient from baseline to different time points during long-term follow-up</measure>
    <time_frame>baseline - week 52</time_frame>
    <description>Change of functional status measured by GPE-DV (monthly evaluation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of functional status of the patient from baseline to different time points during long-term follow-up</measure>
    <time_frame>baseline - week 52</time_frame>
    <description>Change of functional status measured by impact pain on functioning (Interference-BPI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of functional status of the patient from baseline to different time points during long-term follow-up</measure>
    <time_frame>baseline - week 52</time_frame>
    <description>Change of functional status measured by SF-36 (monthly evaluation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The occurrence of tolerance during oral tapentadol treatment from baseline to different time points during long-term follow-up</measure>
    <time_frame>baseline - week 52</time_frame>
    <description>Occurence of tolerance by the use of MQS-III questionnaire (weekly or monthly)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The occurrence of tolerance during oral tapentadol treatment from baseline to different time points during long-term follow-up</measure>
    <time_frame>baseline - week 52</time_frame>
    <description>Occurence of tolerance by the use time-point of discontinuation of study drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug conversion rates from other strong opioids to oral tapentadol from baseline to different time points during long-term follow-up</measure>
    <time_frame>baseline - week 52</time_frame>
    <description>By the use of MQS-III questionnaire</description>
  </secondary_outcome>
  <enrollment type="Actual">55</enrollment>
  <condition>Severe Pain Syndromes</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients suffering from severe pain that did not respond to previous treatment with&#xD;
        strong opioids (either due to (1) insufficient analgesic effectiveness, (2) intolerable&#xD;
        side effects from previous opioid treatment or (3) opioid induced hyperalgesia)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects should be capable of giving their informed consent;&#xD;
&#xD;
          -  Males and females, 18 years and older;&#xD;
&#xD;
          -  Patients suffering from severe pain;&#xD;
&#xD;
          -  Pain symptoms refractory to strong opioids (in previous treatment);&#xD;
&#xD;
               -  Due to side effects&#xD;
&#xD;
               -  Due to insufficient analgesic effectiveness&#xD;
&#xD;
               -  Due to opioid induced hyperalgesia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe renal and/or hepatic insufficiency;&#xD;
&#xD;
          -  Known and/or strong suspicion of allergy to tapentadol;&#xD;
&#xD;
          -  Previous treatment with tapentadol;&#xD;
&#xD;
          -  Presence of any condition for which tapentadol is contraindicated as per its approved&#xD;
             labelling information in Belgium;&#xD;
&#xD;
          -  The patient has no access to a mobile phone and web browser. During the study, an&#xD;
             online system is used to receive messages (SMS and e-mail) for the completing of the&#xD;
             online assessments (through web browser).&#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_official>
    <last_name>Guy Hans, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Antwerp</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AZ Monic</name>
      <address>
        <city>Antwerp</city>
        <zip>2100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Antwerp</name>
      <address>
        <city>Antwerp</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huisartspraktijk Van Peer</name>
      <address>
        <city>Boechout</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Oost-Limburg</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jessa Ziekenhuis Hasselt</name>
      <address>
        <city>Hasselt</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Groeninge</name>
      <address>
        <city>Kortrijk</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Liège (Sart Tilman)</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huisartspraktijk De Vaart</name>
      <address>
        <city>Mechelen</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grand Hôpital Charleroi</name>
      <address>
        <city>Montignies-sur-Sambre</city>
        <zip>6061</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Turnhout</name>
      <address>
        <city>Turnhout</city>
        <zip>2300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>February 8, 2022</last_update_submitted>
  <last_update_submitted_qc>February 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Antwerp</investigator_affiliation>
    <investigator_full_name>Dafne Balemans</investigator_full_name>
    <investigator_title>Clinical Trial Center UZA</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</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/NCT03814993
org study id: PLATINUM
nct id: NCT03814993
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Multicenter observational study to determine the long-term tolerability and analgesic
      effectiveness of oral tapentadol in patients suffering from severe pain syndromes, refractory
      to other strong opioids.
Tapentadol, a centrally acting analgesic. It is indicated in Europe "for the relief of
      moderate to severe acute pain in adults, which can be adequately managed only with opioid
      analgesics" (IR formulation/oral solution) and "for the management of severe chronic pain in
      adults, which can be adequately managed only with opioid analgesics" (SR formulation).
      Tapentadol is reimbursed in Belgium since May 1, 2018. The reimbursement was obtained through
      an article 81 procedure (Chapter IV) which means that the reimbursement is currently
      restricted to the time frame of the contract and that during that period certain questions
      and uncertainties regarding the use of tapentadol in a Belgian setting need to be answered.
      In order to answer the questions raised by the Belgian Healthcare authorities, this study
      will be performed evaluating the application of oral tapentadol in routine clinical practice
      in Belgium. The study is conceived as a nation-wide multicentre prospective
      non-interventional trial. The primary endpoint and secondary endpoints of this study are
      guided by the questions that need to be answered during the course of the contract
      reimbursement, as established by the Belgian health authorities.
observational model: Cohort
time perspective: Prospective
measure: Difference in occurrence of gastrointestinal side effects (nausea, vomiting and constipation) between baseline and week 15
time frame: baseline - week 15
description: Differences in occurence of the PRO-CTCAE items: Nausea, vomiting and constipation
measure: Difference in frequency, severity and interference of selected side effects (dizziness, fatigue, itching, headache, dry mouth, nausea, vomiting, constipation) from baseline to week 52
time frame: baseline - week 52
description: Difference in frequency, severity and interference of selected PRO-CTCAE items
measure: Change From Baseline in Pain Scores on the Numeric Rating Scale baseline to different time points during long-term follow-up
time frame: baseline - week 52
description: Reduction in pain intensity numeric rating scale (PI-NRS). Scale: 0 = no pain and 10 = worst possible pain
measure: Change of health-related quality of life from baseline to different time points during long-term follow-up
time frame: baseline - week 52
description: Change of healt-related quality of life measured by EQ-5D-5L (monthly evaluation)
measure: Change of health-related quality of life from baseline to different time points during long-term follow-up
time frame: baseline - week 52
description: Change of healt-related quality of life measured SF-36 (monthly evaluation)
measure: Change of functional status of the patient from baseline to different time points during long-term follow-up
time frame: baseline - week 52
description: Change of functional status measured by GPE-DV (monthly evaluation)
measure: Change of functional status of the patient from baseline to different time points during long-term follow-up
time frame: baseline - week 52
description: Change of functional status measured by impact pain on functioning (Interference-BPI)
measure: Change of functional status of the patient from baseline to different time points during long-term follow-up
time frame: baseline - week 52
description: Change of functional status measured by SF-36 (monthly evaluation)
measure: The occurrence of tolerance during oral tapentadol treatment from baseline to different time points during long-term follow-up
time frame: baseline - week 52
description: Occurence of tolerance by the use of MQS-III questionnaire (weekly or monthly)
measure: The occurrence of tolerance during oral tapentadol treatment from baseline to different time points during long-term follow-up
time frame: baseline - week 52
description: Occurence of tolerance by the use time-point of discontinuation of study drug
measure: Drug conversion rates from other strong opioids to oral tapentadol from baseline to different time points during long-term follow-up
time frame: baseline - week 52
description: By the use of MQS-III questionnaire
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Guy Hans, Prof.
role: Principal Investigator
affiliation: University Hospital, Antwerp
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
responsible party type: Sponsor-Investigator
investigator affiliation: University Hospital, Antwerp
investigator full name: Dafne Balemans
investigator title: Clinical Trial Center UZA
mesh term: Syndrome