<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/NCT02985216</url>
  </required_header>
  <id_info>
    <org_study_id>YHD1119-301</org_study_id>
    <nct_id>NCT02985216</nct_id>
  </id_info>
  <brief_title>Clinical Trial of YHD1119 in Patients With Peripheral Neuropathic Pain</brief_title>
  <official_title>A Randomized, Double-blind, Active-Controlled, Multi-center, Phase 3 Trial to Compare the Safety and Efficacy Between YHD1119 and Pregabalin in Patients With Peripheral Neuropathic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuhan Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yuhan Corporation</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>
      A Randomized, Double-blind, Active-Controlled, Multi-center, Phase 3 Trial to Compare the&#xD;
      Safety and Efficacy between YHD1119 and Pregabalin in Patients with Peripheral Neuropathic&#xD;
      Pain&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 7, 2017</start_date>
  <completion_date type="Actual">May 2, 2018</completion_date>
  <primary_completion_date type="Actual">April 27, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)</measure>
    <time_frame>Baseline, Day 85</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)</measure>
    <time_frame>Day 1, 8, 15, 22, 29, 57, 85</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Pain Score on the Daily Pain Rating Scale at each visit</measure>
    <time_frame>Day 1, 8, 15, 22, 29, 57, 85</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients proportion of reduction over 30% in Mean Pain Score from Baseline</measure>
    <time_frame>Day 1, 8, 15, 22, 29, 57, 85</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of duration-modification from baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)</measure>
    <time_frame>Day 1, 8, 15, 22, 29, 57, 85</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change (PGIC)</measure>
    <time_frame>Day 85</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression of Change (CGIC)</measure>
    <time_frame>Day 85</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-12 (Short form-12)</measure>
    <time_frame>Baseline, Day 85</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-SSRS (Columbia Suicide Severity Rating Scale)</measure>
    <time_frame>Baseline, Day 8, 29, 85</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">371</enrollment>
  <condition>Peripheral Neuropathic Pain</condition>
  <arm_group>
    <arm_group_label>YHD1119</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>YHD1119 150mg for the first 1 week, then forced titrated to YHD1119 300mg for the 1 week. And then YHD1119 150~600mg for the 2 weeks, then YHD1119 fixed dose was administrated for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lyrica</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lyrica 150mg for the first 1 week, then forced titrated to Lyrica 300mg for the 1 week. And then Lyrica 150~600mg for the 2 weeks, then Lyrica fixed dose was administrated for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>YHD1119</intervention_name>
    <description>YHD1119 150mg, PO YHD1119 300mg, PO&#xD;
YHD1119 600mg, PO</description>
    <arm_group_label>YHD1119</arm_group_label>
    <other_name>Pregabalin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lyrica</intervention_name>
    <description>Lyrica 75mg, PO Lyrica 150mg, PO Lyrica 300mg, PO</description>
    <arm_group_label>Lyrica</arm_group_label>
    <other_name>Pregabalin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed Informed Consent&#xD;
&#xD;
          -  HbA1c ≤ 9.5% diabetes mellitus patients with pain over 6 months in Diabetic Peripheral&#xD;
             Neuropathy or postherpetic Neuralgia patients at least 3 months pain after diagnosis&#xD;
             of skin rash due to herpes zooster&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have Brittle diabetes mellitus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yong Chul KIM, M.D.,Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yong Chul Kim</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</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>Neuralgia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregabalin</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/NCT02985216
org study id: YHD1119-301
nct id: NCT02985216
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A Randomized, Double-blind, Active-Controlled, Multi-center, Phase 3 Trial to Compare the
      Safety and Efficacy between YHD1119 and Pregabalin in Patients with Peripheral Neuropathic
      Pain
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)
time frame: Baseline, Day 85
measure: Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)
time frame: Day 1, 8, 15, 22, 29, 57, 85
measure: Mean Pain Score on the Daily Pain Rating Scale at each visit
time frame: Day 1, 8, 15, 22, 29, 57, 85
measure: Patients proportion of reduction over 30% in Mean Pain Score from Baseline
time frame: Day 1, 8, 15, 22, 29, 57, 85
measure: Change of duration-modification from baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)
time frame: Day 1, 8, 15, 22, 29, 57, 85
measure: Patient Global Impression of Change (PGIC)
time frame: Day 85
measure: Clinical Global Impression of Change (CGIC)
time frame: Day 85
measure: SF-12 (Short form-12)
time frame: Baseline, Day 85
measure: C-SSRS (Columbia Suicide Severity Rating Scale)
time frame: Baseline, Day 8, 29, 85
arm group label: YHD1119
arm group type: Experimental
description: YHD1119 150mg for the first 1 week, then forced titrated to YHD1119 300mg for the 1 week. And then YHD1119 150~600mg for the 2 weeks, then YHD1119 fixed dose was administrated for 8 weeks.
arm group label: Lyrica
arm group type: Active Comparator
description: Lyrica 150mg for the first 1 week, then forced titrated to Lyrica 300mg for the 1 week. And then Lyrica 150~600mg for the 2 weeks, then Lyrica fixed dose was administrated for 8 weeks.
intervention type: Drug
intervention name: YHD1119
description: YHD1119 150mg, PO YHD1119 300mg, PO
YHD1119 600mg, PO
arm group label: YHD1119
other name: Pregabalin
intervention type: Drug
intervention name: Lyrica
description: Lyrica 75mg, PO Lyrica 150mg, PO Lyrica 300mg, PO
arm group label: Lyrica
other name: Pregabalin
criteria: 
gender: All
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yong Chul KIM, M.D.,Ph.D.
role: Principal Investigator
affiliation: Seoul National University
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Neuralgia
mesh term: Pregabalin