<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/NCT02997696</url>
  </required_header>
  <id_info>
    <org_study_id>ONO-4474-02</org_study_id>
    <secondary_id>2016-002675-97</secondary_id>
    <nct_id>NCT02997696</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate ONO-4474 in Patients With Pain Due to Osteoarthritis of the Knee</brief_title>
  <acronym>MOTION</acronym>
  <official_title>A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of ONO-4474 in Patients With Pain Due to Osteoarthritis of the Knee</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ono Pharmaceutical Co. Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ono Pharmaceutical Co. Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this phase 2, randomised, double-blind, placebo controlled, parallel group,&#xD;
      multicentre study is to investigate the efficacy, safety, tolerability and pharmacokinetics&#xD;
      of a compound ONO-4474 in patients with moderate to severe pain due to osteoarthritis of the&#xD;
      knee following 4 weeks of oral administration of ONO-4474.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was stopped for business reasons. No safety issues were reported.&#xD;
  </why_stopped>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">January 9, 2018</completion_date>
  <primary_completion_date type="Actual">January 9, 2018</primary_completion_date>
  <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in mean daily average index knee pain while walking</measure>
    <time_frame>Week 4</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety profile assessed by adverse events, vital signs, laboratory tests, 12-lead electrocardiograms (ECG), physical examination</measure>
    <time_frame>From baseline to study completion, an average of 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of ONO-4474 as assessed by C-SSRS (evaluation of suicidal ideation and behavior)</measure>
    <time_frame>From baseline to study completion, an average of 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of ONO-4474 as assessed by neurological examination</measure>
    <time_frame>From baseline to study completion, an average of 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in mean daily average index knee pain while walking</measure>
    <time_frame>Week 1, Week 2, Week 3 and Weeks 1-4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain, stiffness and physical function scores</measure>
    <time_frame>Week 1, Week 2, Week 4 and Weeks 1-4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in overall WOMAC score</measure>
    <time_frame>Week 1, Week 2, Week 4 and Weeks 1-4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in mean daily average index knee pain</measure>
    <time_frame>Week 1, Week 2, Week 3, Week 4 and Weeks 1-4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Patient Global Assessment</measure>
    <time_frame>Week 1, Week 2, Week 4 and Weeks 1-4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement score in Clinical Global Impression</measure>
    <time_frame>Week 1, Week 2, Week 4 and Weeks 1-4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in: EuroQoL EQ-5D-5L</measure>
    <time_frame>Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of rescue medication as total number of tablets taken</measure>
    <time_frame>Week 1, Week 2, Week 3, Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first rescue medication use</measure>
    <time_frame>Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of ONO-4474 in plasma: Ctrough of ONO-4474</measure>
    <time_frame>Week 1, Week 2 and Week 4</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Percentage of patients who meet Osteoarthritis Research Society International - Outcome Measures in Rheumatology (OMERACT-OARSI) responder criteria</measure>
    <time_frame>Week 1, Week 2 and Week 4</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of patients who report a ≥30%, ≥50% or ≥70% decrease versus baseline in mean daily average index knee pain while walking</measure>
    <time_frame>Weeks 1, 2, 3 and 4, and Weeks 1-4</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of patients who report a ≥30%, ≥50% or ≥70% decrease versus baseline in WOMAC pain score</measure>
    <time_frame>Weeks 1, 2 and 4, and Weeks 1-4</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of patients who report a ≥30%, ≥50% or ≥70% decrease versus baseline in WOMAC physical function score</measure>
    <time_frame>Weeks 1, 2 and 4, and Weeks 1-4</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline to study completion in mean daily average index knee pain while walking</measure>
    <time_frame>From baseline to study completion, an average of 6 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline to study completion in WOMAC pain score</measure>
    <time_frame>From baseline to study completion, an average of 6 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline to study completion in WOMAC physical function score</measure>
    <time_frame>From baseline to study completion, an average of 6 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline to study completion in PGA</measure>
    <time_frame>From baseline to study completion, an average of 6 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change of daily average index knee pain while walking versus daily physical activity</measure>
    <time_frame>From baseline to study completion, an average of 6 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change of average index knee pain versus daily physical activity</measure>
    <time_frame>From baseline to study completion, an average of 6 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Ctrough versus change from baseline to Weeks 1, 2 and 4 in WOMAC pain score</measure>
    <time_frame>Week 1, Week 2 and Week 4</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Ctrough versus change from baseline to Weeks 1, 2 and 4 in WOMAC physical function score</measure>
    <time_frame>Week 1, Week 2 and Week 4</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Ctrough versus change from baseline to Weeks 1, 2 and 4 in PGA</measure>
    <time_frame>Week 1, Week 2 and Week 4</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Experimental arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ONO-4474 low dose every day for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental arm 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ONO-4474 high dose every day for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo matching ONO-4474 every day for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ONO-4474</intervention_name>
    <arm_group_label>Experimental arm 1</arm_group_label>
    <arm_group_label>Experimental arm 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo matching ONO-4474</intervention_name>
    <arm_group_label>Placebo arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Symptomatic OA of the knee for ≥3 months diagnosed prior to screening as per American&#xD;
             College of Rheumatology clinical criteria.&#xD;
&#xD;
          -  Radiographic evidence of tibiofemoral OA of index knee (Kellgren-Lawrence grade 2-3),&#xD;
             as confirmed at screening.&#xD;
&#xD;
          -  Moderate to severe index knee pain due to OA requiring use of analgesic medication.&#xD;
&#xD;
          -  Willing to discontinue use of all analgesic medication (aside from rescue medication)&#xD;
             during the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of, or history of,&#xD;
&#xD;
               1. any inflammatory arthritis (e.g. gout, reactive arthritis, psoriatic arthritis,&#xD;
                  seronegative spondylarthropathy, septic arthritis, previous diagnosis of&#xD;
                  pseudogout in target joint with proven crystals on joint aspiration or elevated&#xD;
                  C-Reactive Protein (CRP) at time of knee arthritis flare),&#xD;
&#xD;
               2. RPOA, osteonecrosis, osteoporotic fracture or any other painful joint disease&#xD;
                  other than OA,&#xD;
&#xD;
               3. Secondary causes of OA; other rheumatologic or musculoskeletal conditions (e.g.,&#xD;
                  rheumatoid arthritis, fibromyalgia, septic arthritis, congenital abnormality).&#xD;
&#xD;
          -  Orthopaedic surgery of a lower extremity or any major surgery within the previous 6&#xD;
             months prior to Visit 1 or has plans for surgical intervention during the study.&#xD;
&#xD;
          -  Symptomatic hip OA.&#xD;
&#xD;
          -  A history of partial or complete joint replacement surgery in the index knee at any&#xD;
             time or anticipating knee surgery during the study period.&#xD;
&#xD;
          -  Significant knee injury or any knee surgery (including arthroscopy) in the index knee&#xD;
             within 6 months prior to screening.&#xD;
&#xD;
          -  Uncontrolled diabetes.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philip Conaghan, MBBS PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Leeds Institute of Rheumatic and Musculoskeletal Medicine, Chapel Allerton Hospital, Leeds, UK</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Aalborg</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Frederiksberg</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site 4504</name>
      <address>
        <city>Odense</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Balatonfured</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Eger</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Kistarcsa</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Mezokovesd</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Szolnok</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site 4808</name>
      <address>
        <city>Bialystok</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site 4818</name>
      <address>
        <city>Bialystok</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site 4819</name>
      <address>
        <city>Bialystok</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Elblag</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Gdynia</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Katowice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Kielce</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site 4810</name>
      <address>
        <city>Krakow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site 4812</name>
      <address>
        <city>Krakow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Lublin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Nadarzyn</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Poznan</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Siedlce</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Staszow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site 4811</name>
      <address>
        <city>Warszawa</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site 4815</name>
      <address>
        <city>Warszawa</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Wroclaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site 4801</name>
      <address>
        <city>Zamosc</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site 4816</name>
      <address>
        <city>Zamosc</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>A Coruna</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site 3406</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site 3407</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site 3402</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site 3410</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Mostoles</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Sabadell</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Santiago de Compostela</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational site</name>
      <address>
        <city>Villajoyosa</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Barnsley</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Blackpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site 4401</name>
      <address>
        <city>Leeds</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site 4410</name>
      <address>
        <city>Leeds</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Middlesex</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>North Shields</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Romford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Hungary</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>February 23, 2018</last_update_submitted>
  <last_update_submitted_qc>February 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2018</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>
  <!-- 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/NCT02997696
org study id: ONO-4474-02
secondary id: 2016-002675-97
nct id: NCT02997696
lead sponsor: 
has dmc: No
The purpose of this phase 2, randomised, double-blind, placebo controlled, parallel group,
      multicentre study is to investigate the efficacy, safety, tolerability and pharmacokinetics
      of a compound ONO-4474 in patients with moderate to severe pain due to osteoarthritis of the
      knee following 4 weeks of oral administration of ONO-4474.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline in mean daily average index knee pain while walking
time frame: Week 4
measure: Safety profile assessed by adverse events, vital signs, laboratory tests, 12-lead electrocardiograms (ECG), physical examination
time frame: From baseline to study completion, an average of 6 weeks
measure: Safety of ONO-4474 as assessed by C-SSRS (evaluation of suicidal ideation and behavior)
time frame: From baseline to study completion, an average of 6 weeks
measure: Safety of ONO-4474 as assessed by neurological examination
time frame: From baseline to study completion, an average of 6 weeks
measure: Change from baseline in mean daily average index knee pain while walking
time frame: Week 1, Week 2, Week 3 and Weeks 1-4
measure: Change from baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain, stiffness and physical function scores
time frame: Week 1, Week 2, Week 4 and Weeks 1-4
measure: Change from baseline in overall WOMAC score
time frame: Week 1, Week 2, Week 4 and Weeks 1-4
measure: Change from baseline in mean daily average index knee pain
time frame: Week 1, Week 2, Week 3, Week 4 and Weeks 1-4
measure: Change from baseline in Patient Global Assessment
time frame: Week 1, Week 2, Week 4 and Weeks 1-4
measure: Improvement score in Clinical Global Impression
time frame: Week 1, Week 2, Week 4 and Weeks 1-4
measure: Change from baseline in: EuroQoL EQ-5D-5L
time frame: Week 4
measure: Use of rescue medication as total number of tablets taken
time frame: Week 1, Week 2, Week 3, Week 4
measure: Time to first rescue medication use
time frame: Week 4
measure: Pharmacokinetics of ONO-4474 in plasma: Ctrough of ONO-4474
time frame: Week 1, Week 2 and Week 4
measure: Percentage of patients who meet Osteoarthritis Research Society International - Outcome Measures in Rheumatology (OMERACT-OARSI) responder criteria
time frame: Week 1, Week 2 and Week 4
measure: Percentage of patients who report a ≥30%, ≥50% or ≥70% decrease versus baseline in mean daily average index knee pain while walking
time frame: Weeks 1, 2, 3 and 4, and Weeks 1-4
measure: Percentage of patients who report a ≥30%, ≥50% or ≥70% decrease versus baseline in WOMAC pain score
time frame: Weeks 1, 2 and 4, and Weeks 1-4
measure: Percentage of patients who report a ≥30%, ≥50% or ≥70% decrease versus baseline in WOMAC physical function score
time frame: Weeks 1, 2 and 4, and Weeks 1-4
measure: Change from baseline to study completion in mean daily average index knee pain while walking
time frame: From baseline to study completion, an average of 6 weeks
measure: Change from baseline to study completion in WOMAC pain score
time frame: From baseline to study completion, an average of 6 weeks
measure: Change from baseline to study completion in WOMAC physical function score
time frame: From baseline to study completion, an average of 6 weeks
measure: Change from baseline to study completion in PGA
time frame: From baseline to study completion, an average of 6 weeks
measure: Change of daily average index knee pain while walking versus daily physical activity
time frame: From baseline to study completion, an average of 6 weeks
measure: Change of average index knee pain versus daily physical activity
time frame: From baseline to study completion, an average of 6 weeks
measure: Ctrough versus change from baseline to Weeks 1, 2 and 4 in WOMAC pain score
time frame: Week 1, Week 2 and Week 4
measure: Ctrough versus change from baseline to Weeks 1, 2 and 4 in WOMAC physical function score
time frame: Week 1, Week 2 and Week 4
measure: Ctrough versus change from baseline to Weeks 1, 2 and 4 in PGA
time frame: Week 1, Week 2 and Week 4
arm group label: Experimental arm 1
arm group type: Experimental
description: ONO-4474 low dose every day for 4 weeks
arm group label: Experimental arm 2
arm group type: Experimental
description: ONO-4474 high dose every day for 4 weeks
arm group label: Placebo arm
arm group type: Placebo Comparator
description: Placebo matching ONO-4474 every day for 4 weeks
intervention type: Drug
intervention name: ONO-4474
arm group label: Experimental arm 1
arm group label: Experimental arm 2
intervention type: Drug
intervention name: Placebo matching ONO-4474
arm group label: Placebo arm
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Philip Conaghan, MBBS PhD
role: Principal Investigator
affiliation: Leeds Institute of Rheumatic and Musculoskeletal Medicine, Chapel Allerton Hospital, Leeds, UK
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country: Denmark
country: Hungary
country: Poland
country: Spain
country: United Kingdom
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee