<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/NCT01719588</url>
  </required_header>
  <id_info>
    <org_study_id>CR100918</org_study_id>
    <secondary_id>R331333PAI4007</secondary_id>
    <secondary_id>TPD-C-12-PH-001-V02</secondary_id>
    <nct_id>NCT01719588</nct_id>
  </id_info>
  <brief_title>A Safety and Effectiveness Study of Prolonged Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Chronic Non-Cancer Pain</brief_title>
  <official_title>A Post-Marketing Surveillance (PMS) Study on the Safety and Effectiveness of Prolonged Release Tapentadol Hydrochloride Among Adult Filipino Patients With Moderate To Severe Chronic Non-Cancer Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Pharmaceutica</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Pharmaceutica</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and effectiveness of prolonged release&#xD;
      tapentadol hydrochloride for the relief of moderate to severe chronic non-cancer pain among&#xD;
      Filipino patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label (all people know the identity of the intervention), multi-center (study&#xD;
      conducted at multiple sites), observational study (study in which the investigators/&#xD;
      physicians observe the patients and measure their outcomes). The study will enroll&#xD;
      approximately 100 patients who will be taking prolonged release tapentadol hydrochloride with&#xD;
      a dosing regimen stipulated in the product insert. As this is an observational study,&#xD;
      assessment of patient will be based on the accepted clinical practice in the Philippines.&#xD;
      Patients will be monitored at baseline (Day 1) and throughout the 84-day treatment period of&#xD;
      prolonged release tapentadol hydrochloride (every 7 days for the first two weeks, and&#xD;
      thereafter every 28 days for the next three months) for effectiveness with the help of short&#xD;
      form Brief Pain Inventory (BPI) questionnaire. Safety evaluations will include assessment of&#xD;
      adverse events, clinical laboratory tests, and co-morbid conditions. The total study will be&#xD;
      conducted for 3 years and the duration of treatment will be for 84 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The company decided to cancel this study in conformity with PH FDA Circular 2013-004&#xD;
  </why_stopped>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">November 2016</completion_date>
  <primary_completion_date type="Anticipated">November 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with incidence of adverse events and adverse drug reactions</measure>
    <time_frame>From the date of first exposure of patient to the study medication until 30 days after the last dose of the study medication and at anytime the investigator deems it as necessary, as assessed for 3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The short form Brief Pain Inventory (BPI) questionnaire scores</measure>
    <time_frame>Baseline (Day 1), Day 7, Day 14 and Day 28, Day 56, and Day 84</time_frame>
    <description>The short form BPI allows patients to rate the severity of their pain on a scale of 0 (no pain) to 10 (pain as bad as you can imagine) and the degree to which their pain interferes with common dimensions of feeling and function (general activity, walking, work, mood, enjoyment of life, relations with others, and sleep) on a scale of 0 (no interference) to 10 (interferes completely).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Moderate to Severe Chronic Non-cancer Pain</condition>
  <arm_group>
    <arm_group_label>Prolonged release tapentadol</arm_group_label>
    <description>Patients will be taking prolonged release tapentadol hydrochloride as per the product insert approved in Philippines.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>This is an observational study. Prolonged release tapentadol hydrochloride will be administered as per the recommended doses approved in Philippines. The recommended oral starting dose is 50 mg, 100 mg, 150 mg, 200 mg, or 250 mg every 12 hours, with or without food depending on the initial pain intensity and thereafter, the dose will be adjusted to maintain adequate analgesia with acceptable tolerability. The dosing regimen will be individualized according to the severity of pain being treated, the previous treatment experience, and the ability to monitor patients.</description>
    <arm_group_label>Prolonged release tapentadol</arm_group_label>
    <other_name>Nucynta PR</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Filipino patients with moderate to severe chronic non-cancer pain and who are on the&#xD;
        approved product label of prolonged release tapentadol hydrochloride&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Filipino patients with moderate to severe non-cancer pain with an onset of 12 weeks or&#xD;
             less from the baseline visit and pain requires Schedule 2 opioid treatment as per&#xD;
             assessment of the prescribing physician&#xD;
&#xD;
          -  Patients who able to independently communicate pain characteristics, understand and&#xD;
             complete self administered questionnaires&#xD;
&#xD;
          -  Medically stable on the basis of routine physical examination, medical history, and&#xD;
             vital signs at the time of baseline visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refuse to protocol-defined use of effective contraception&#xD;
&#xD;
          -  Pregnant and lactating women&#xD;
&#xD;
          -  Patients with severe renal and hepatic impairment, significant respiratory depression,&#xD;
             acute or severe bronchial asthma or hypercapnia, and having or suspected paralytic&#xD;
             ileus&#xD;
&#xD;
          -  Patients with acute intoxication with alcohol, hypnotics, centrally acting analgesics,&#xD;
             or psychotropic drugs or receiving other mu-opioid receptor agonist analgesics,&#xD;
             general anesthetics, phenothiazines, other tranquilizers, and sedatives&#xD;
&#xD;
          -  Patients who are receiving Monoamine oxidase (MAO) inhibitors or who have taken them&#xD;
             within the last 14 days&#xD;
&#xD;
          -  Patients with documented history of increased intracranial pressure, impaired&#xD;
             consciousness, coma and seizure&#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>Janssen Pharmaceutica Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Pharmaceutica</affiliation>
  </overall_official>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>November 30, 2015</last_update_submitted>
  <last_update_submitted_qc>November 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Moderate to severe chronic non-cancer pain</keyword>
  <keyword>Prolonged release tapentadol hydrochloride</keyword>
  <keyword>Tapentadol PR</keyword>
  <keyword>Extended release tapentadol hydrochloride</keyword>
  <keyword>Nucynta PR</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tapentadol</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/NCT01719588
org study id: CR100918
secondary id: R331333PAI4007
secondary id: TPD-C-12-PH-001-V02
nct id: NCT01719588
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the safety and effectiveness of prolonged release
      tapentadol hydrochloride for the relief of moderate to severe chronic non-cancer pain among
      Filipino patients.
This is an open-label (all people know the identity of the intervention), multi-center (study
      conducted at multiple sites), observational study (study in which the investigators/
      physicians observe the patients and measure their outcomes). The study will enroll
      approximately 100 patients who will be taking prolonged release tapentadol hydrochloride with
      a dosing regimen stipulated in the product insert. As this is an observational study,
      assessment of patient will be based on the accepted clinical practice in the Philippines.
      Patients will be monitored at baseline (Day 1) and throughout the 84-day treatment period of
      prolonged release tapentadol hydrochloride (every 7 days for the first two weeks, and
      thereafter every 28 days for the next three months) for effectiveness with the help of short
      form Brief Pain Inventory (BPI) questionnaire. Safety evaluations will include assessment of
      adverse events, clinical laboratory tests, and co-morbid conditions. The total study will be
      conducted for 3 years and the duration of treatment will be for 84 days.
observational model: Case-Only
time perspective: Prospective
measure: Number of patients with incidence of adverse events and adverse drug reactions
time frame: From the date of first exposure of patient to the study medication until 30 days after the last dose of the study medication and at anytime the investigator deems it as necessary, as assessed for 3 years
measure: The short form Brief Pain Inventory (BPI) questionnaire scores
time frame: Baseline (Day 1), Day 7, Day 14 and Day 28, Day 56, and Day 84
description: The short form BPI allows patients to rate the severity of their pain on a scale of 0 (no pain) to 10 (pain as bad as you can imagine) and the degree to which their pain interferes with common dimensions of feeling and function (general activity, walking, work, mood, enjoyment of life, relations with others, and sleep) on a scale of 0 (no interference) to 10 (interferes completely).
arm group label: Prolonged release tapentadol
description: Patients will be taking prolonged release tapentadol hydrochloride as per the product insert approved in Philippines.
intervention type: Drug
intervention name: No intervention
description: This is an observational study. Prolonged release tapentadol hydrochloride will be administered as per the recommended doses approved in Philippines. The recommended oral starting dose is 50 mg, 100 mg, 150 mg, 200 mg, or 250 mg every 12 hours, with or without food depending on the initial pain intensity and thereafter, the dose will be adjusted to maintain adequate analgesia with acceptable tolerability. The dosing regimen will be individualized according to the severity of pain being treated, the previous treatment experience, and the ability to monitor patients.
arm group label: Prolonged release tapentadol
other name: Nucynta PR
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen Pharmaceutica Clinical Trial
role: Study Director
affiliation: Janssen Pharmaceutica
responsible party type: Sponsor
mesh term: Tapentadol