<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/NCT03793010</url>
  </required_header>
  <id_info>
    <org_study_id>FX006-2018-015</org_study_id>
    <nct_id>NCT03793010</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Flexion Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Flexion Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a two-part, multi-center, randomized, double-blind, placebo-controlled,&#xD;
      parallel-group study in patients with hip OA. Approximately 70 patients will be enrolled in&#xD;
      Part I and approximately 440 patients will be enrolled in Part II of the study. In each part,&#xD;
      patients will be randomized to one of two treatment groups (1:1) and treated with a single IA&#xD;
      injection of either 32 mg FX006 or normal saline.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a two-part, multi-center, randomized, double-blind, placebo-controlled,&#xD;
      parallel-group study in patients with hip OA. Approximately 70 patients will be enrolled in&#xD;
      Part I and approximately 440 patients will be enrolled in Part II of the study. In each part,&#xD;
      patients will be randomized to one of two treatment groups (1:1) and treated with a single IA&#xD;
      injection of either 32 mg FX006 or normal saline.&#xD;
&#xD;
      FX006 or saline placebo will be administered as a single IA injection with a 12-week&#xD;
      follow-up period in the double-blind phase.&#xD;
&#xD;
      Patients participating in Part I of the study will be treated with a single IA injection of&#xD;
      either 32 mg FX006 or normal saline and will return for follow up visits at Weeks 12, 16, 20,&#xD;
      and 24. The patients will be discontinued at the time of notification by the Investigator.&#xD;
&#xD;
      Patients participating in Part II of the study will be treated with a single IA injection of&#xD;
      either 32 mg FX006 or normal saline and will return for follow up visits at Weeks 12, 16, 20,&#xD;
      and 24.&#xD;
&#xD;
      Patients participating in Part II of the study that are not clinically indicated for a second&#xD;
      injection at Week 12 will return to the clinic at Weeks 16, 20, and 24 and will receive an&#xD;
      open-label injection of FX006 at the first evaluation where the patient has been determined&#xD;
      to meet all criteria. Patients will then return for follow-up visits every 4 weeks for 12&#xD;
      weeks post second injection and will complete the study 12 weeks post second injection (e.g.,&#xD;
      Week 24, 28, 32, or 36 depending on when the patient receives the open-label injection).&#xD;
&#xD;
      Patients participating in Part II of the study who are not eligible for a second injection&#xD;
      after evaluation at Weeks 12, 16, 20, and 24 will complete the study at the Week 24 visit and&#xD;
      complete the End of Study (EOS) assessments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    By Sponsor due to occurrences of incomplete study drug administration&#xD;
  </why_stopped>
  <start_date type="Actual">December 12, 2018</start_date>
  <completion_date type="Actual">August 7, 2019</completion_date>
  <primary_completion_date type="Actual">August 7, 2019</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>
    <intervention_model_description>Randomized, Double-blind, Placebo-controlled, Parallel-group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in WOMAC A (Pain) Score at Week 12</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>The change from baseline on the average Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A (pain) score at Week 12. The average WOMAC A score is calculated by taking the average of five questions with a range from 0 (no pain) to 10 (extreme pain).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in WOMAC C (Function) Score at Week 12</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>Change from Baseline on the WOMAC C (function) score at Week 12. The average WOMAC C score is calculated by taking the average of seventeen questions with a range from 0 (no difficulty) to 10 (extreme difficulty).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PGIC Score at Week 12</measure>
    <time_frame>12 Weeks</time_frame>
    <description>PGIC (Patient Global Impression of Change) at Week 12. The PGIC score has a range from 1(very much improved) to 7 (very much worse) and indicates the overall status of the patient since baseline.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Osteoarthritis, Hip</condition>
  <arm_group>
    <arm_group_label>FX006</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FX006 32mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal Saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FX006</intervention_name>
    <description>Single Intra-articular injection</description>
    <arm_group_label>FX006</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>Single Intra-articular injection</description>
    <arm_group_label>Normal Saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willingness and ability to comply with the study procedures and visit schedules and&#xD;
             ability to follow verbal and written instructions&#xD;
&#xD;
          -  Patients 40 to 80 years of age, inclusive, on the day of randomization (Day 1)&#xD;
&#xD;
          -  Body Mass Index (BMI) ≤ 40 kg/m2&#xD;
&#xD;
          -  Symptoms associated with OA of the index hip for ≥ 3 months prior to Screening visit&#xD;
&#xD;
          -  Currently meet the American College of Radiology (ACR) Criteria (clinical and&#xD;
             radiological) for OA of the index hip&#xD;
&#xD;
          -  Kellgren-Lawrence (KL) Grade 2 or 3 in the index hip as confirmed by X-ray during&#xD;
             Screening visit (centrally read)&#xD;
&#xD;
          -  Qualifying mean score on the WOMAC A and C (0-10 NRS scale)&#xD;
&#xD;
          -  Agree to maintain the similar activity level throughout the study&#xD;
&#xD;
          -  Willingness to abstain from use of restricted medications&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who cannot washout of prohibited medications&#xD;
&#xD;
          -  Diagnosed as secondary OA in the index hip including but not limited to articular&#xD;
             fracture, major dysplasia or congenital abnormality, osteochondritis dissecans,&#xD;
             acromegaly, ochronosis, hemochromatosis, Wilson's disease, or primary&#xD;
             osteochondromatosis, etc.&#xD;
&#xD;
          -  Ipsilateral chronic knee pain&#xD;
&#xD;
          -  Sciatica&#xD;
&#xD;
          -  Atrophic osteoarthritis, femoral head necrosis and/or collapse, or subchondral bone&#xD;
             insufficiency fracture in the index hip joint determined via central reading&#xD;
&#xD;
          -  Current or history of infection in the index hip (e.g. osteomyelitis) or current skin&#xD;
             infection at injection site&#xD;
&#xD;
          -  Trauma or surgeries (e.g., arthroscopy, knee surgery) of lower limbs within 52 weeks&#xD;
             with sequelae, etc.&#xD;
&#xD;
          -  History or current evidence of reactive arthritis, rheumatoid arthritis, psoriatic&#xD;
             arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel&#xD;
             disease, systemic lupus erythematosus or other autoimmune diseases&#xD;
&#xD;
          -  Any planned surgeries in the lower limbs during the study period, or any other surgery&#xD;
             during the study period that would require use of a restricted medication&#xD;
&#xD;
          -  Presence of surgical hardware or other foreign body in the index hip&#xD;
&#xD;
          -  Planned/anticipated surgery of the index hip or any other surgery that would require&#xD;
             use of a restricted medication during the study period&#xD;
&#xD;
          -  IA corticosteroid of any joint within 3 months of Screening visit (investigational or&#xD;
             marketed, including FX006)&#xD;
&#xD;
          -  IA treatment of index hip with any of the following agents within 6 months of&#xD;
             Screening: any biologic agent or hyaluronic acid (investigational or marketed)&#xD;
&#xD;
          -  IV or IM corticosteroids (investigational or marketed) within 3 months of Screening&#xD;
&#xD;
          -  Oral corticosteroids (investigational or marketed) within 1 month of Screening&#xD;
&#xD;
          -  Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2&#xD;
             weeks of Screening visit&#xD;
&#xD;
          -  Planned or expected changes to lifestyle with regard to physical activity, physical&#xD;
             therapy, acupuncture, transcutaneous electrical nerve stimulation (TENS), or bracing&#xD;
             within 1 month prior to Screening and changes throughout the duration of the study&#xD;
&#xD;
          -  Women of child-bearing potential (not surgically sterile or post-menopausal for at&#xD;
             least 1 year as documented in medical history) not using a highly effective method or&#xD;
             who are pregnant or nursing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Scott Kelley, MD</last_name>
    <role>Study Director</role>
    <affiliation>Flexion Therapeutics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arizona Research Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85053</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Noble Clinical Research</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hope Clinical Research</name>
      <address>
        <city>Canoga Park</city>
        <state>California</state>
        <zip>91303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TriWest Research Associates, LLC</name>
      <address>
        <city>El Cajon</city>
        <state>California</state>
        <zip>92020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BioSolutions Clinical Research Center</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Artemis Institute for Clinical Research</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mountain View Clinical Research, Inc.</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chase Medical Research, LLC</name>
      <address>
        <city>Waterbury</city>
        <state>Connecticut</state>
        <zip>06708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampa Bay Medical Research</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Research Associates, LLC</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Research for Health Improvement</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medallion Clinical Research Institute, LLC</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oviedo Medical Research</name>
      <address>
        <city>Oviedo</city>
        <state>Florida</state>
        <zip>32765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Progressive Medical Research</name>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <zip>32127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Precision Clinical Research, LLC</name>
      <address>
        <city>Sunrise</city>
        <state>Florida</state>
        <zip>33351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Pain Research Institute</name>
      <address>
        <city>Winter Park</city>
        <state>Florida</state>
        <zip>32789</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Better Health Clinical Research, Inc</name>
      <address>
        <city>Newnan</city>
        <state>Georgia</state>
        <zip>30265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Injury Care Research, LLC</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University Feinberg School of Medicine</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heartland Research Associates</name>
      <address>
        <city>Newton</city>
        <state>Kansas</state>
        <zip>67114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Excel Clinical Research</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drug Trials America</name>
      <address>
        <city>Hartsdale</city>
        <state>New York</state>
        <zip>10530</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M3 Wake Research, Inc.</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Wilmington</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Orthopedics Center</name>
      <address>
        <city>Altoona</city>
        <state>Pennsylvania</state>
        <zip>16602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altoona Center for Clinical Research</name>
      <address>
        <city>Duncansville</city>
        <state>Pennsylvania</state>
        <zip>16635</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Carolina Research Center</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wasatch Clinical Research, LLC</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charlottesville Medical Research</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spectrum Medical, Inc.</name>
      <address>
        <city>Danville</city>
        <state>Virginia</state>
        <zip>24541</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Clinical Research Center</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <results_first_submitted>August 7, 2020</results_first_submitted>
  <results_first_submitted_qc>August 24, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 14, 2020</results_first_posted>
  <last_update_submitted>January 13, 2022</last_update_submitted>
  <last_update_submitted_qc>January 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Osteoarthritis</keyword>
  <keyword>Hip</keyword>
  <keyword>Pain</keyword>
  <keyword>Intra-articular</keyword>
  <keyword>Injection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Hip</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>FX006</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 31, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT03793010/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 5, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT03793010/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The recruitment period for this study was from December 2018 until August 2019. The patients were enrolled at medical clinics.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>FX006</title>
          <description>FX006 32mg&#xD;
FX006: Single Intra-articular injection</description>
        </group>
        <group group_id="P2">
          <title>Normal Saline</title>
          <description>Normal Saline&#xD;
Normal saline: Single Intra-articular injection</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Randomized But Not Dosed</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawn by Investigator or Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Patient couldn't sit still for injection</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrew to pursue other treatment</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did not meet eligibility criteria</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All patients who received a full dose of study drug assigned to the FX006 32 mg arm and the placebo arm were included in the analysis. 68 total patients were included in the safety population.</population>
      <group_list>
        <group group_id="B1">
          <title>FX006</title>
          <description>FX006 32mg&#xD;
FX006: Single Intra-articular injection</description>
        </group>
        <group group_id="B2">
          <title>Normal Saline</title>
          <description>Normal Saline&#xD;
Normal saline: Single Intra-articular injection</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="33"/>
            <count group_id="B2" value="35"/>
            <count group_id="B3" value="68"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.6" spread="9.45"/>
                    <measurement group_id="B2" value="61.8" spread="7.99"/>
                    <measurement group_id="B3" value="60.7" spread="8.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.50" spread="5.679"/>
                    <measurement group_id="B2" value="31.29" spread="5.775"/>
                    <measurement group_id="B3" value="30.91" spread="5.699"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in WOMAC A (Pain) Score at Week 12</title>
        <description>The change from baseline on the average Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A (pain) score at Week 12. The average WOMAC A score is calculated by taking the average of five questions with a range from 0 (no pain) to 10 (extreme pain).</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>All patients who received a full dose of study drug assigned to the FX006 32 mg arm and the placebo arm were included in the analysis. 68 total patients were included in the safety analysis. 55 of 68 patients had Week 12 assessments and are included in the primary and secondary outcomes analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>FX006</title>
            <description>FX006 32mg&#xD;
FX006: Single Intra-articular injection</description>
          </group>
          <group group_id="O2">
            <title>Normal Saline</title>
            <description>Normal Saline&#xD;
Normal saline: Single Intra-articular injection</description>
          </group>
        </group_list>
        <measure>
          <title>Change in WOMAC A (Pain) Score at Week 12</title>
          <description>The change from baseline on the average Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A (pain) score at Week 12. The average WOMAC A score is calculated by taking the average of five questions with a range from 0 (no pain) to 10 (extreme pain).</description>
          <population>All patients who received a full dose of study drug assigned to the FX006 32 mg arm and the placebo arm were included in the analysis. 68 total patients were included in the safety analysis. 55 of 68 patients had Week 12 assessments and are included in the primary and secondary outcomes analysis.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.85" lower_limit="-2.99" upper_limit="-0.71"/>
                    <measurement group_id="O2" value="-2.16" lower_limit="-3.22" upper_limit="-1.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.20</ci_lower_limit>
            <ci_upper_limit>1.81</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in WOMAC C (Function) Score at Week 12</title>
        <description>Change from Baseline on the WOMAC C (function) score at Week 12. The average WOMAC C score is calculated by taking the average of seventeen questions with a range from 0 (no difficulty) to 10 (extreme difficulty).</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>All patients who received a full dose of study drug assigned to the FX006 32 mg arm and the placebo arm were included in the analysis. 68 total patients were included in the safety population. 55 of 68 patients had week 12 assessments and are included in the primary and secondary outcomes analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>FX006</title>
            <description>FX006 32mg&#xD;
FX006: Single Intra-articular injection</description>
          </group>
          <group group_id="O2">
            <title>Normal Saline</title>
            <description>Normal Saline&#xD;
Normal saline: Single Intra-articular injection</description>
          </group>
        </group_list>
        <measure>
          <title>Change in WOMAC C (Function) Score at Week 12</title>
          <description>Change from Baseline on the WOMAC C (function) score at Week 12. The average WOMAC C score is calculated by taking the average of seventeen questions with a range from 0 (no difficulty) to 10 (extreme difficulty).</description>
          <population>All patients who received a full dose of study drug assigned to the FX006 32 mg arm and the placebo arm were included in the analysis. 68 total patients were included in the safety population. 55 of 68 patients had week 12 assessments and are included in the primary and secondary outcomes analysis.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.56" lower_limit="-2.73" upper_limit="-0.40"/>
                    <measurement group_id="O2" value="-2.16" lower_limit="-3.30" upper_limit="-1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.60</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.05</ci_lower_limit>
            <ci_upper_limit>2.24</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PGIC Score at Week 12</title>
        <description>PGIC (Patient Global Impression of Change) at Week 12. The PGIC score has a range from 1(very much improved) to 7 (very much worse) and indicates the overall status of the patient since baseline.</description>
        <time_frame>12 Weeks</time_frame>
        <population>All patients who received a full dose of study drug assigned to the FX006 32 mg arm and the placebo arm were included in the analysis. 68 total patients were included in the safety population. 55 of 68 patients had week 12 assessments and are included in the primary and secondary outcomes analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>FX006</title>
            <description>FX006 32mg&#xD;
FX006: Single Intra-articular injection</description>
          </group>
          <group group_id="O2">
            <title>Normal Saline</title>
            <description>Normal Saline&#xD;
Normal saline: Single Intra-articular injection</description>
          </group>
        </group_list>
        <measure>
          <title>PGIC Score at Week 12</title>
          <description>PGIC (Patient Global Impression of Change) at Week 12. The PGIC score has a range from 1(very much improved) to 7 (very much worse) and indicates the overall status of the patient since baseline.</description>
          <population>All patients who received a full dose of study drug assigned to the FX006 32 mg arm and the placebo arm were included in the analysis. 68 total patients were included in the safety population. 55 of 68 patients had week 12 assessments and are included in the primary and secondary outcomes analysis.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" lower_limit="2.7" upper_limit="4.1"/>
                    <measurement group_id="O2" value="3.4" lower_limit="2.8" upper_limit="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.0</ci_lower_limit>
            <ci_upper_limit>0.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>FX006</title>
          <description>FX006 32mg&#xD;
FX006: Single Intra-articular injection</description>
        </group>
        <group group_id="E2">
          <title>Normal Saline</title>
          <description>Normal Saline&#xD;
Normal saline: Single Intra-articular injection</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (21.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Peptic Ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Adhesion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Chest Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Thirst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Gastroenteritis Viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod Bite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Repetitive Strain Injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood Glucose Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Blood Pressure Diastolic Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Blood Pressure Increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Hepatic Enzyme Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Weight Increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>White Blood Cell Count Decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Apetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Diabetes Mellitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Intervertebral Disc Protrusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Lumbar Radiculopathy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal Cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intertrigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot Flush</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This study was terminated early by the Sponsor due to occurrences of incomplete study drug administration. Only 15% of the planned study population had enrolled and no statistical evaluations reported due to insufficient sample size.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>David Golod, Vice President, Clinical Operations</name_or_title>
      <organization>Flexion Therapeutics, Inc.</organization>
      <phone>(781) 305-7572</phone>
      <email>dgolod@flexiontherapeutics.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03793010
org study id: FX006-2018-015
nct id: NCT03793010
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a two-part, multi-center, randomized, double-blind, placebo-controlled,
      parallel-group study in patients with hip OA. Approximately 70 patients will be enrolled in
      Part I and approximately 440 patients will be enrolled in Part II of the study. In each part,
      patients will be randomized to one of two treatment groups (1:1) and treated with a single IA
      injection of either 32 mg FX006 or normal saline.
This is a two-part, multi-center, randomized, double-blind, placebo-controlled,
      parallel-group study in patients with hip OA. Approximately 70 patients will be enrolled in
      Part I and approximately 440 patients will be enrolled in Part II of the study. In each part,
      patients will be randomized to one of two treatment groups (1:1) and treated with a single IA
      injection of either 32 mg FX006 or normal saline.

      FX006 or saline placebo will be administered as a single IA injection with a 12-week
      follow-up period in the double-blind phase.

      Patients participating in Part I of the study will be treated with a single IA injection of
      either 32 mg FX006 or normal saline and will return for follow up visits at Weeks 12, 16, 20,
      and 24. The patients will be discontinued at the time of notification by the Investigator.

      Patients participating in Part II of the study will be treated with a single IA injection of
      either 32 mg FX006 or normal saline and will return for follow up visits at Weeks 12, 16, 20,
      and 24.

      Patients participating in Part II of the study that are not clinically indicated for a second
      injection at Week 12 will return to the clinic at Weeks 16, 20, and 24 and will receive an
      open-label injection of FX006 at the first evaluation where the patient has been determined
      to meet all criteria. Patients will then return for follow-up visits every 4 weeks for 12
      weeks post second injection and will complete the study 12 weeks post second injection (e.g.,
      Week 24, 28, 32, or 36 depending on when the patient receives the open-label injection).

      Patients participating in Part II of the study who are not eligible for a second injection
      after evaluation at Weeks 12, 16, 20, and 24 will complete the study at the Week 24 visit and
      complete the End of Study (EOS) assessments.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, Double-blind, Placebo-controlled, Parallel-group
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in WOMAC A (Pain) Score at Week 12
time frame: Baseline and Week 12
description: The change from baseline on the average Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A (pain) score at Week 12. The average WOMAC A score is calculated by taking the average of five questions with a range from 0 (no pain) to 10 (extreme pain).
measure: Change in WOMAC C (Function) Score at Week 12
time frame: Baseline and Week 12
description: Change from Baseline on the WOMAC C (function) score at Week 12. The average WOMAC C score is calculated by taking the average of seventeen questions with a range from 0 (no difficulty) to 10 (extreme difficulty).
measure: PGIC Score at Week 12
time frame: 12 Weeks
description: PGIC (Patient Global Impression of Change) at Week 12. The PGIC score has a range from 1(very much improved) to 7 (very much worse) and indicates the overall status of the patient since baseline.
arm group label: FX006
arm group type: Experimental
description: FX006 32mg
arm group label: Normal Saline
arm group type: Placebo Comparator
description: Normal Saline
intervention type: Drug
intervention name: FX006
description: Single Intra-articular injection
arm group label: FX006
intervention type: Drug
intervention name: Normal saline
description: Single Intra-articular injection
arm group label: Normal Saline
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Scott Kelley, MD
role: Study Director
affiliation: Flexion Therapeutics, Inc.
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country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Hip
mesh term: FX006
provided document: 
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reported events: 
certain agreements: 
limitations and caveats: This study was terminated early by the Sponsor due to occurrences of incomplete study drug administration. Only 15% of the planned study population had enrolled and no statistical evaluations reported due to insufficient sample size.
point of contact: 