<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/NCT03768466</url>
  </required_header>
  <id_info>
    <org_study_id>OXN18-KR-401</org_study_id>
    <nct_id>NCT03768466</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Oxycodone/Naloxone (Targin®) in Persistent Moderate to Severe Low Back Pain Following NSAIDs Treatment</brief_title>
  <official_title>An 8-week, Prospective, Interventional, Single-arm, Multi-centre, Phase IV Study to Evaluate the Efficacy and Safety of Controlled-release Oxycodone/Naloxone (Targin®) in Moderate to Severe Low Back Pain Patients Who Are Not Adequately Controlled by NSAIDs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mundipharma Korea Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mundipharma Korea Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy of the study drug (Targin®) after 8&#xD;
      weeks of treatment in patients with moderate to severe low back pain who are uncontrolled* by&#xD;
      NSAIDs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 21, 2018</start_date>
  <completion_date type="Actual">September 17, 2020</completion_date>
  <primary_completion_date type="Actual">February 20, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of NRS average score from week 0 to week 8</measure>
    <time_frame>week 8</time_frame>
    <description>reduction of pain intensity of week 8 average NRS score</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">123</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Brand Name: Targin®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Brand Name: Targin®</intervention_name>
    <description>Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral</description>
    <arm_group_label>Brand Name: Targin®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Korean patients age ≥ 19 years old&#xD;
&#xD;
          2. Patients having moderate to severe low back pain (NRS pain score ≥4) for ≥ 7 days and&#xD;
             ≤ 90 days not satisfactorily controlled with NSAIDs&#xD;
&#xD;
          3. Patients showing average NRS pain score ≥4 over the last 1 week at screening point&#xD;
&#xD;
          4. In case of previous opioids medication history, opioids wash-out period &gt; 30 days&#xD;
             before enrolment&#xD;
&#xD;
          5. Patients who is willing to voluntarily sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with any history of hypersensitivity to oxycodone, naloxone or related&#xD;
             products&#xD;
&#xD;
          2. Low back pain coming from cancer, infectious disease, psychiatric issue or congenial&#xD;
             cause&#xD;
&#xD;
          3. Pregnant or lactating women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>JaeHyup Lee</last_name>
    <role>Principal Investigator</role>
    <affiliation>SMG-SNU Boramae Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SMG-SNU Boramae Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>07061</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>January 21, 2021</last_update_submitted>
  <last_update_submitted_qc>January 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>March 23, 2022</submitted>
    <submission_canceled>March 25, 2022</submission_canceled>
    <submitted>March 31, 2022</submitted>
    <returned>August 19, 2022</returned>
  </pending_results>
  <!-- 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/NCT03768466
org study id: OXN18-KR-401
nct id: NCT03768466
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the efficacy of the study drug (Targin®) after 8
      weeks of treatment in patients with moderate to severe low back pain who are uncontrolled* by
      NSAIDs.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change of NRS average score from week 0 to week 8
time frame: week 8
description: reduction of pain intensity of week 8 average NRS score
arm group label: Brand Name: Targin®
arm group type: Experimental
description: Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral
intervention type: Drug
intervention name: Brand Name: Targin®
description: Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral
arm group label: Brand Name: Targin®
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: JaeHyup Lee
role: Principal Investigator
affiliation: SMG-SNU Boramae Medical Center
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No
submitted: March 23, 2022
submission canceled: March 25, 2022
submitted: March 31, 2022
returned: August 19, 2022