<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/NCT01688583</url>
  </required_header>
  <id_info>
    <org_study_id>CR100728</org_study_id>
    <secondary_id>FENPAI4094</secondary_id>
    <secondary_id>FEN-KOR-5045</secondary_id>
    <nct_id>NCT01688583</nct_id>
  </id_info>
  <brief_title>The Effectiveness and Tolerability of Fentanyl Matrix in Chronic Non-cancer Pain; Assessment of Patient's Pain Treatment Goal Achievement</brief_title>
  <official_title>The Effectiveness and Tolerability of Fentanyl Matrix in Chronic Non-cancer Pain; Assessment of Patient's Pain Treatment Goal Achievement: Multicenter, Prospective, Open-label, Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Korea, Ltd., Korea</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Korea, Ltd., Korea</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the effectiveness and tolerability of Fentanyl matrix&#xD;
      in chronic non-cancer pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter, prospective (a study in which the patients are identified and then&#xD;
      followed forward in time for the outcome of the study), open-label (all people know the&#xD;
      identity of the intervention), observational study intended to examine the effectiveness of&#xD;
      Fentanyl matrix through the degree of improvement of pain. Fentanyl matrix is a transdermal&#xD;
      (through the skin) system providing continuous delivery of fentanyl for 72 hours. Fentanyl&#xD;
      matrix will be administered to patients with chronic (prolonged) non-cancer pain under&#xD;
      routine practice during 12 weeks. Dose will be adjusted in accordance with patient's degree&#xD;
      of pain and treatment response in the investigator's judgment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 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>The percentage of patients with mean % Pain Intensity Difference (%PID) &gt;= 50% from baseline to endpoint</measure>
    <time_frame>12 weeks</time_frame>
    <description>Pain intensity will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change from baseline in mean pain intensity</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>Pain intensity will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The difference between the patient's pain treatment goal set at baseline</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>The degree of pain the patient wishes to achieve by the end of treatment, set at baseline. The degree of pain will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The degree of night sleep disturbance due to pain</measure>
    <time_frame>12 weeks</time_frame>
    <description>Sleep disturbance due to pain will be measured using a Numeric Rating Scale (NRS): 1 = None, 10 = Complete.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The degree of Interference with Daily Life Performance due to Pain</measure>
    <time_frame>12 weeks</time_frame>
    <description>The degree of interference with daily life performance due to pain will be assessed on a 5-point scale: 1 = No interference, 5 = Great interference. Daily life performance means household work performance, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The degree of Interference with Social Life Performance due to Pain</measure>
    <time_frame>12 weeks</time_frame>
    <description>The degree of interference with social life performance due to pain will be measured on a 5-point scale; 1 = No interference, 5 = Great interference. Social life performance means interpersonal relationship, going out, working life, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The patient's global assessment of pain treatment</measure>
    <time_frame>12 weeks</time_frame>
    <description>The patient will assess on a 5-point scale (1= not effective, 5= greatly effective) how effective the study drug has been in the judgment of the study participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The investigator's global assessment of pain treatment</measure>
    <time_frame>12 weeks</time_frame>
    <description>The investigator will assess on a 5-point scale (1= not effective, 5= greatly effective) how effective the study drug has been for a patient, in the judgment of the investigator.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">410</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Fentanyl matrix</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl matrix</intervention_name>
    <description>Dose will be adjusted in accordance with patient's degree of pain and treatment response in the investigator's judgment.</description>
    <arm_group_label>Fentanyl matrix</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who complain of chronic pain and have pain inadequately controlled by previous&#xD;
        treatment with narcotic analgesics (eg, tramadols, codeines, morphines, oxycodone), and are&#xD;
        judged to require Fentanyl matrix administration will participate in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Complain of chronic non-cancer pain that persists for &gt;= 3 months&#xD;
&#xD;
          -  Pain inadequately controlled by previous treatment with narcotic analgesics (opium or&#xD;
             opium-like compounds with potent analgesic effects, eg, tramadol, codeine, morphine,&#xD;
             oxycodone)&#xD;
&#xD;
          -  Women must be postmenopausal, surgically sterile, abstinent, or practicing an&#xD;
             effective method of birth control if they have childbearing potential&#xD;
&#xD;
          -  Male patients who agree to use a method of birth control and not to donate sperm for 1&#xD;
             month after the last dose of the study drug&#xD;
&#xD;
          -  A written informed consent for study participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Experience of treatment with Fentanyl matrix within the past 4 weeks&#xD;
&#xD;
          -  No previous experience of use of narcotic analgesics&#xD;
&#xD;
          -  Past or current history of alcohol or drug abuse&#xD;
&#xD;
          -  Cannot use transdermal analgesics due to skin disorder&#xD;
&#xD;
          -  Have serious psychiatric disorder and cannot complete overall study procedures and&#xD;
             questionnaire in the judgment of the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Korea, Ltd., Korea Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Korea, Ltd., Korea</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Andong</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Goyang</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jeonju-Si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kwangiu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kwanju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wonju-Si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <last_update_submitted>November 20, 2013</last_update_submitted>
  <last_update_submitted_qc>November 20, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic pain</keyword>
  <keyword>Chronic non-cancer pain</keyword>
  <keyword>Fentanyl matrix</keyword>
  <keyword>Transdermal system</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</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/NCT01688583
org study id: CR100728
secondary id: FENPAI4094
secondary id: FEN-KOR-5045
nct id: NCT01688583
lead sponsor: 
The purpose of this study is to assess the effectiveness and tolerability of Fentanyl matrix
      in chronic non-cancer pain.
This is a multicenter, prospective (a study in which the patients are identified and then
      followed forward in time for the outcome of the study), open-label (all people know the
      identity of the intervention), observational study intended to examine the effectiveness of
      Fentanyl matrix through the degree of improvement of pain. Fentanyl matrix is a transdermal
      (through the skin) system providing continuous delivery of fentanyl for 72 hours. Fentanyl
      matrix will be administered to patients with chronic (prolonged) non-cancer pain under
      routine practice during 12 weeks. Dose will be adjusted in accordance with patient's degree
      of pain and treatment response in the investigator's judgment.
observational model: Cohort
time perspective: Prospective
measure: The percentage of patients with mean % Pain Intensity Difference (%PID) >= 50% from baseline to endpoint
time frame: 12 weeks
description: Pain intensity will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
measure: The change from baseline in mean pain intensity
time frame: Baseline, Week 12
description: Pain intensity will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
measure: The difference between the patient's pain treatment goal set at baseline
time frame: Baseline, Week 12
description: The degree of pain the patient wishes to achieve by the end of treatment, set at baseline. The degree of pain will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
measure: The degree of night sleep disturbance due to pain
time frame: 12 weeks
description: Sleep disturbance due to pain will be measured using a Numeric Rating Scale (NRS): 1 = None, 10 = Complete.
measure: The degree of Interference with Daily Life Performance due to Pain
time frame: 12 weeks
description: The degree of interference with daily life performance due to pain will be assessed on a 5-point scale: 1 = No interference, 5 = Great interference. Daily life performance means household work performance, etc.
measure: The degree of Interference with Social Life Performance due to Pain
time frame: 12 weeks
description: The degree of interference with social life performance due to pain will be measured on a 5-point scale; 1 = No interference, 5 = Great interference. Social life performance means interpersonal relationship, going out, working life, etc.
measure: The patient's global assessment of pain treatment
time frame: 12 weeks
description: The patient will assess on a 5-point scale (1= not effective, 5= greatly effective) how effective the study drug has been in the judgment of the study participant.
measure: The investigator's global assessment of pain treatment
time frame: 12 weeks
description: The investigator will assess on a 5-point scale (1= not effective, 5= greatly effective) how effective the study drug has been for a patient, in the judgment of the investigator.
arm group label: Fentanyl matrix
intervention type: Drug
intervention name: Fentanyl matrix
description: Dose will be adjusted in accordance with patient's degree of pain and treatment response in the investigator's judgment.
arm group label: Fentanyl matrix
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen Korea, Ltd., Korea Clinical Trial
role: Study Director
affiliation: Janssen Korea, Ltd., Korea
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Chronic Pain
mesh term: Fentanyl