<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/NCT04421911</url>
  </required_header>
  <id_info>
    <org_study_id>KETO-2019</org_study_id>
    <nct_id>NCT04421911</nct_id>
  </id_info>
  <brief_title>A Study to Assess Efficacy and Safety of the Ketoprofen vs Diclofenac</brief_title>
  <official_title>A Study to Comparing the Efficacy and Safety of the Ketoprofen and Diclofenac in Patients With Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Handok Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Handok Inc.</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>
      Primary objective:&#xD;
&#xD;
      • To assess therapeutic efficacy of the Ketoprofen compared with Diclofenac based on the&#xD;
      assessment of primary endpoint : Mean change in walking arthritis pain intensity score&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        -  To assess therapeutic efficacy of the Ketoprofen compared with Diclofenac based on the&#xD;
           assessment of secondary endpoints.&#xD;
&#xD;
        -  To assess safety and tolerability of the Ketoprofen compared with Diclofenac based on&#xD;
           the nature and frequency of adverse events in treatment groups&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial is designed as an open-label, multicenter, randomized, clinical study for&#xD;
      assessment of efficacy and safety of Ketoprofen plaster and Diclofenac plaster in patients&#xD;
      with osteoarthritis&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2020</start_date>
  <completion_date type="Actual">September 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2020</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change in walking arthritis pain intensity score</measure>
    <time_frame>3 weeks</time_frame>
    <description>Pain will be assessed by a horizontal 100 mm Visual Analogue Scale (VAS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change in spontaneous arthritis pain intensity score</measure>
    <time_frame>3 weeks</time_frame>
    <description>Pain will be assessed by a horizontal 100 mm Visual Analogue Scale (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>3 weeks</time_frame>
    <description>Mean change in individual parameters and the general normalized Knee injury and Osteoarthritis Outcome Score (KOOS) score (5-point scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Impression of Improvement (PGI-I)</measure>
    <time_frame>3 weeks</time_frame>
    <description>Patient Global Impression of Improvement (PGI-I) assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>3 weeks</time_frame>
    <description>frequency, severity, relationship with the study drug</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">236</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>ketoprofen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Diclofenac</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketoprofen topical</intervention_name>
    <description>Ketoprofen topical for 21days</description>
    <arm_group_label>ketoprofen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diclofenac Topical</intervention_name>
    <description>Diclofenac topical for 21days</description>
    <arm_group_label>Diclofenac</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 40-75 years&#xD;
&#xD;
          -  Compliance to ACR diagnostic criteria of OA of the knee&#xD;
&#xD;
          -  Patients with Kellgren-Lawrence grade 1-3&#xD;
&#xD;
          -  Index knee pain should be ≥40 mm on VAS (100mm) scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intolerance or allergic reactions to the study therapy&#xD;
&#xD;
          -  Usage of NSAIDs within 3 days&#xD;
&#xD;
          -  Open skin lesions or dermatological conditions at the site of plaster application&#xD;
&#xD;
          -  Surgery or major trauma of the index knee within the previous 12 months&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Alcohol addiction, drug addiction or drug abuse in the past&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Maksimum Zdorovya</name>
      <address>
        <city>Kemerovo</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Hospital #1 n.a. Pirogova</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rostov State Medical University</name>
      <address>
        <city>Rostov-on-Don</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ryazan State Medical University n.a. I.P.Pavlov</name>
      <address>
        <city>Ryazan</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saratov State Medical University n.a. V.I.Razumovsky</name>
      <address>
        <city>Saratov</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private Healthcare Institution Smolensk Russian Railway Clinical Hospital</name>
      <address>
        <city>Smolensk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ulyanovsk Regional Clinical Hospital</name>
      <address>
        <city>Ulyanovsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Clinical Hospital</name>
      <address>
        <city>Vladimir</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Emergency Hospital n.a. N.V.Soloviev</name>
      <address>
        <city>Yaroslavl</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>January 19, 2021</last_update_submitted>
  <last_update_submitted_qc>January 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ketoprofen</keyword>
  <keyword>diclofenac</keyword>
  <keyword>osteoarthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diclofenac</mesh_term>
    <mesh_term>Ketoprofen</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04421911
org study id: KETO-2019
nct id: NCT04421911
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Primary objective:

      • To assess therapeutic efficacy of the Ketoprofen compared with Diclofenac based on the
      assessment of primary endpoint : Mean change in walking arthritis pain intensity score

      Secondary objectives:

        -  To assess therapeutic efficacy of the Ketoprofen compared with Diclofenac based on the
           assessment of secondary endpoints.

        -  To assess safety and tolerability of the Ketoprofen compared with Diclofenac based on
           the nature and frequency of adverse events in treatment groups
This trial is designed as an open-label, multicenter, randomized, clinical study for
      assessment of efficacy and safety of Ketoprofen plaster and Diclofenac plaster in patients
      with osteoarthritis
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean change in walking arthritis pain intensity score
time frame: 3 weeks
description: Pain will be assessed by a horizontal 100 mm Visual Analogue Scale (VAS)
measure: Mean change in spontaneous arthritis pain intensity score
time frame: 3 weeks
description: Pain will be assessed by a horizontal 100 mm Visual Analogue Scale (VAS)
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
time frame: 3 weeks
description: Mean change in individual parameters and the general normalized Knee injury and Osteoarthritis Outcome Score (KOOS) score (5-point scale)
measure: Global Impression of Improvement (PGI-I)
time frame: 3 weeks
description: Patient Global Impression of Improvement (PGI-I) assessment
measure: Adverse events
time frame: 3 weeks
description: frequency, severity, relationship with the study drug
arm group label: ketoprofen
arm group type: Experimental
arm group label: Diclofenac
arm group type: Active Comparator
intervention type: Drug
intervention name: Ketoprofen topical
description: Ketoprofen topical for 21days
arm group label: ketoprofen
intervention type: Drug
intervention name: Diclofenac Topical
description: Diclofenac topical for 21days
arm group label: Diclofenac
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Diclofenac
mesh term: Ketoprofen
sharing ipd: No