xml: <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/NCT06021444</url>
    </required_header>
    <id_info>
      <org_study_id>DKM-420-MD-1</org_study_id>
      <nct_id>NCT06021444</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of DKM420 in Patients With Osteoarthritis of Knee</brief_title>
    <official_title>A Multi-center, Randomized, Double-blind, Active-controlled, Pivotal, Non-inferiority Clinical Study to Evaluate the Efficacy and Safety of 'DKM420' in Knee Osteoarthritis Patients.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dongkook Pharmaceutical Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Dongkook Pharmaceutical Co., Ltd.</source>
    <oversight_info>
      <has_dmc>Yes</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>
        To prove the non-inferiority of DKM420 by evaluating the injecting efficacy and safety DKM&#xD;
        420 and control for patients who have osteoarthritis of Knee.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A multi-center, randomized, double-blind, active-controlled, pivotal, non-inferiority&#xD;
        clinical study&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 30, 2020</start_date>
    <completion_date type="Actual">July 18, 2023</completion_date>
    <primary_completion_date type="Actual">June 1, 2023</primary_completion_date>
    <phase>N/A</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>
      <intervention_model_description>1:1 Parallel.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Care Provider, Outcomes Assessor)</masking>
      <masking_description>Blind: Investigator&#xD;
  Un-blind: Investigator(or CRC).</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>100mm VAS(Visual Analogue Scale)</measure>
      <time_frame>16 weeks</time_frame>
      <description>Change(The minimum value is 0mm, the maximum value is 100m, the lower the better.)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>100mm VAS(Visual Analogue Scale)</measure>
      <time_frame>2, 8 weeks</time_frame>
      <description>Change(The minimum value is 0mm, the maximum value is 100m, the lower the better.)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>K-WOMAC(Korean Western Ontario and McMaster Universities)</measure>
      <time_frame>2, 8, 16 weeks</time_frame>
      <description>Change(Score from 0 to 96, the lower the better.)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">250</enrollment>
    <condition>Osteoarthritis of Knee</condition>
    <arm_group>
      <arm_group_label>DKM420</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Injecting to one side knee.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Conjuran</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Injecting to one side knee.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>DKM420</intervention_name>
      <description>A total of 3 doses will be applied at a dose of 2 mL over 3 weeks.</description>
      <arm_group_label>DKM420</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Conjuran</intervention_name>
      <description>A total of 3 doses will be applied at a dose of 2 mL over 3 weeks.</description>
      <arm_group_label>Conjuran</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Men and Women who is over 40 under 80 ages.&#xD;
  &#xD;
            -  Diagnosed as osteoarthritis of Knee and satisfies the 3 of 6 ACR(American College of&#xD;
               Rheumatology) conditions.&#xD;
  &#xD;
            -  Kellgren Lawrence grade (Ⅰ~Ⅲ) at Visit 1 or within 24 weeks.&#xD;
  &#xD;
            -  100mm VAS(Visual Analogue Scale) over 40mm.&#xD;
  &#xD;
            -  Etc.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - Pregnancy and lactating women&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>H Plus Yangji Hospital</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</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>Osteoarthritis</mesh_term>
      <mesh_term>Osteoarthritis, Knee</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06021444
  org study id: DKM-420-MD-1
  nct id: NCT06021444
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  To prove the non-inferiority of DKM420 by evaluating the injecting efficacy and safety DKM
        420 and control for patients who have osteoarthritis of Knee.
  A multi-center, randomized, double-blind, active-controlled, pivotal, non-inferiority
        clinical study
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: 1:1 Parallel.
  primary purpose: Treatment
  masking: Double (Care Provider, Outcomes Assessor)
  masking description: Blind: Investigator
  Un-blind: Investigator(or CRC).
  measure: 100mm VAS(Visual Analogue Scale)
  time frame: 16 weeks
  description: Change(The minimum value is 0mm, the maximum value is 100m, the lower the better.)
  measure: 100mm VAS(Visual Analogue Scale)
  time frame: 2, 8 weeks
  description: Change(The minimum value is 0mm, the maximum value is 100m, the lower the better.)
  measure: K-WOMAC(Korean Western Ontario and McMaster Universities)
  time frame: 2, 8, 16 weeks
  description: Change(Score from 0 to 96, the lower the better.)
  arm group label: DKM420
  arm group type: Experimental
  description: Injecting to one side knee.
  arm group label: Conjuran
  arm group type: Active Comparator
  description: Injecting to one side knee.
  intervention type: Device
  intervention name: DKM420
  description: A total of 3 doses will be applied at a dose of 2 mL over 3 weeks.
  arm group label: DKM420
  intervention type: Device
  intervention name: Conjuran
  description: A total of 3 doses will be applied at a dose of 2 mL over 3 weeks.
  arm group label: Conjuran
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 80 Years
  healthy volunteers: No
  facility: 
  country: Korea, Republic of
  responsible party type: Sponsor
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee
  sharing ipd: No