<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/NCT03028870</url>
  </required_header>
  <id_info>
    <org_study_id>VAN2001</org_study_id>
    <nct_id>NCT03028870</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Analgesic Efficacy and Safety of V120083 in Subjects With Osteoarthritis (OA) of the Knee</brief_title>
  <official_title>A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled and Active-controlled, Parallel-group Study Evaluating the Analgesic Efficacy and Safety of V120083 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Purdue Pharma LP</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shionogi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Purdue Pharma LP</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study is to evaluate the analgesic efficacy of V120083 twice daily&#xD;
      compared to placebo in subjects with moderate to severe chronic pain due to OA of the knee.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 14, 2017</start_date>
  <completion_date type="Actual">November 21, 2017</completion_date>
  <primary_completion_date type="Actual">November 10, 2017</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Daily &quot;Average Pain Over the Last 24 Hours&quot; Score at Week 4</measure>
    <time_frame>Week 4</time_frame>
    <description>At week 4, subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weekly Change From Baseline Score of &quot;Average Pain Over the Last 24 Hours&quot; From the mBPI-SF Pain Severity Subscale</measure>
    <time_frame>Weeks 1, 2 and 4</time_frame>
    <description>Subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Daily &quot;Pain Right Now&quot; Score Collected by e-Diary</measure>
    <time_frame>4 Weeks</time_frame>
    <description>Subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale</measure>
    <time_frame>4 Weeks</time_frame>
    <description>The pain subscale consisted of 5 items: walking; stair climbing; nocturnal; at rest; weight bearing. The score for each item ranged from 0 (none) to 4 (extreme). The pain subscale score was obtained by adding the responses to the 5 items which could range from 0 to 20.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale</measure>
    <time_frame>4 Weeks</time_frame>
    <description>The stiffness subscale consisted of 2 items; morning stiffness and stiffness occurring later in the day. The score for each item ranged from 0 (none) to 4 (extreme) and the stiffness subscale score was obtained by adding the responses to the 2 items which could range from 0 - 8.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale</measure>
    <time_frame>4 Weeks</time_frame>
    <description>The physical function subscale consisted of 17 items: descending stairs; ascending stairs; rising from sitting; standing; bending to floor; walking on flat surface; getting into or out of car; going shopping; putting on socks; rising from bed; taking off socks; lying in bed; sitting; getting into or out of the bathtub; getting on or off the toilet; heavy domestic duties; light domestic duties. The score for each item ranged from 0 (none) to 4 (extreme) and the physical function subscale score was obtained by adding the responses to the 17 items which could range from 0 to 68.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score</measure>
    <time_frame>4 Weeks</time_frame>
    <description>The total score of the WOMAC consisted of 24 items (5 items from the pain subscale, 2 items from the stiffness subscale, and 17 items from the physical function subscale). The total score was obtained by adding the scores from these 3 subscales and could range from 0 to 96.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Score (All Parts of 6 Questions)</measure>
    <time_frame>4 Weeks</time_frame>
    <description>The mBPI-SF consists of 6 questions and is a self-administered questionnaire used to assess the severity of pain, and the interference of pain on daily functions. Subjects rated their severity of pain / interference of pain on a 0 (no pain / does not interfere) to 10 (as bad as you can imagine / completely interferes) numerical rating scale (NRS) The total score is the sum of all parts of the 6 questions and the total score range is 0 - 110.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score</measure>
    <time_frame>4 Weeks</time_frame>
    <description>The mBPI-SF is a self-administered questionnaire. The pain severity subscale of the mBPI-SF consists of 4 questions which ask the subjects to rate their severity of pain on a 0 to 10 NRS for worst pain, least pain, average pain, and current pain. The severity of pain was computed as the mean of questions 1-4. The mean severity of pain scores could range from 0 to 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score</measure>
    <time_frame>4 Weeks</time_frame>
    <description>The mBPI-SF is a self-administered questionnaire. The pain interference subscale of the mBPI-SF consists of Question 6 which has 7 parts, all of which ask the subjects to rate the impact/interference of their pain on various functions, ie, general activity, mood, walking, normal work, relations with others, sleep, and enjoyment of life on a 0 to 10 NRS where 0 = does not interfere and 10 = completely interferes. The mean interference of pain scores could range from 0 to 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Responder to Treatment (Calculated as the Percentage Reduction of &quot;Average Pain Over the Last 24 Hours&quot;) at Week 4</measure>
    <time_frame>Week 4</time_frame>
    <description>A subject's response to treatment was defined as the percentage reduction from the baseline &quot;average pain over the last 24 hours&quot; score to the week 4 pain score from the mBPI-SF pain severity subscale. Responders were defined as having &gt; 0 % reduction; non-responders were defined as having ≤ 0% reduction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary</measure>
    <time_frame>4 Weeks</time_frame>
    <description>The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH).&#xD;
The Physical Component Summary is derived from 4 of the 8 health dimensions (aggregate of PF, RP, BP, and GH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical Outcomes Study Short Form-36 (SF-36) - Mental Component Summary</measure>
    <time_frame>4 Weeks</time_frame>
    <description>The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH).&#xD;
The Mental Component Summary is derived from 4 of the 8 health dimensions,(aggregate of VT, SF, RE, and MH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Quality of Life Scale - 5 Dimensions (EQ-5D-5L) to Measure Health Status</measure>
    <time_frame>4 Weeks</time_frame>
    <description>EQ-5D-5L is a standardized generic measure of health status for clinical and economic appraisal based on a descriptive system that defines health in terms of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It includes a visual analogue scale (VAS) with scores ranging from 0 (&quot;worst imaginable health state&quot;) to 100 (&quot;best imaginable health state&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change (PGIC)</measure>
    <time_frame>4 Weeks</time_frame>
    <description>The PGIC is an ordinal scale which assesses the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse), where 1 = very much improved and 7 = very much worse. The number of subjects responding &quot;very much improved&quot; and &quot;much improved&quot; was summarized by treatment group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Supplemental Analgesic Medication Use</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>The average daily number of tablets of supplemental pain medication used during the double-blind period was summarized by treatment group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS)</measure>
    <time_frame>Baseline up to 4 Weeks</time_frame>
    <description>Suicidality was monitored throughout the study using the C-SSRS. The C-SSRS involves a series of probing questions to inquire about possible suicidal thinking and behavior. The composite endpoints (Suicidal Ideation, Suicidal Behavior, Suicidal Ideation or Behavior) included subjects who experienced any one of the events at least once during treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 4 in Hospital Anxiety and Depression Scale (HADS) Score</measure>
    <time_frame>Week 4</time_frame>
    <description>Safety assessment to evaluate the impact of V120083 on mood (anxiety [HADS-A] and depression [HADS-D]). The score for each subscale ranges from 0 (no anxiety or depression) to 21, with a score of 11 or higher indicating the probable presence of the mood disorder.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">291</enrollment>
  <condition>Osteo Arthritis Knee</condition>
  <arm_group>
    <arm_group_label>V120083 30 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>V120083 30-mg capsules taken orally twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>V120083 60 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>V120083 60-mg (2 x 30 mg) capsules taken orally twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Naproxen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Naproxen 500-mg capsules taken orally twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Capsules to match V120083 and/or naproxen taken orally twice daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>V120083</intervention_name>
    <description>Capsules</description>
    <arm_group_label>V120083 30 mg</arm_group_label>
    <arm_group_label>V120083 60 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Naproxen</intervention_name>
    <description>Capsules</description>
    <arm_group_label>Naproxen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Capsules to match V120083 and/or naproxen</description>
    <arm_group_label>Naproxen</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>V120083 30 mg</arm_group_label>
    <arm_group_label>V120083 60 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria Include:&#xD;
&#xD;
          1. Males and females ≥ 40 and ≤ 80 years of age with moderate to severe chronic OA pain&#xD;
             of the knee (lasting several hours daily) as their predominant pain condition for at&#xD;
             least 6 months prior to screening&#xD;
&#xD;
          2. Diagnostic criteria for primary pain condition (American College of Rheumatology [ACR]&#xD;
             clinical and radiographic criteria):&#xD;
&#xD;
               -  At least 1 of the following in addition to knee pain: age &gt; 50, morning stiffness&#xD;
                  &lt; 30 minutes, crepitus on active motion, and&#xD;
&#xD;
               -  Kellgren-Lawrence (K-L) grade 2 or 3 radiographic evidence at the screening visit&#xD;
                  as determined by a local radiologist or rheumatologist. If a radiograph is not&#xD;
                  available, one must be taken and the diagnostic criteria must be confirmed before&#xD;
                  randomization.&#xD;
&#xD;
          3. Subjects whose OA pain of the index knee is not adequately treated prior to the&#xD;
             screening visit:&#xD;
&#xD;
               -  Subjects must have a self-reported average pain intensity rating of moderate or&#xD;
                  severe on a verbal rating scale (ie, none, mild, moderate, and severe) over the 7&#xD;
                  days prior to the screening visit&#xD;
&#xD;
          4. The subjects must have &quot;average pain over the last 24 hours&quot; scores ≥ 4 and ≤ 9 on an&#xD;
             11-point numerical rating scale (NRS) for the index knee on ≥ 3 consecutive days&#xD;
             during the pain assessment period and come in for randomization within 96 hours after&#xD;
             the latest qualifying pain score entry&#xD;
&#xD;
          5. Subjects who are willing and able to stop taking any/all analgesic medications,&#xD;
             including over-the-counter pain medications, opioids, marijuana, and topical&#xD;
             analgesics for OA pain for the duration of the study, with the exception of&#xD;
             study-specific rescue medication.&#xD;
&#xD;
        Key Exclusion Criteria Include:&#xD;
&#xD;
          1. Subjects with radiographic evidence of OA with K-L grade 0,1 or 4&#xD;
&#xD;
          2. Subjects with chronic pain conditions other than OA of the knee as their predominant&#xD;
             pain condition, including gout, pseudogout, psoriatic arthritis, active Lyme disease,&#xD;
             rheumatoid arthritis or any other inflammatory arthritis, fibromyalgia, neuropathic&#xD;
             pain conditions, bursitis, or acute injury or signs of active infection in the target&#xD;
             pain area&#xD;
&#xD;
          3. Subjects scheduled for surgical interventions of the disease site or any other major&#xD;
             surgery during the study conduct period&#xD;
&#xD;
          4. Subjects with a history of a prior joint replacement of the index knee&#xD;
&#xD;
          5. Subjects who have had arthroscopy on either knee or hip within 6 months of entering&#xD;
             the study, or open surgery on either knee or hip within 12 months of entering the&#xD;
             study&#xD;
&#xD;
          6. Subjects with a history of significant trauma to a knee, hip or shoulder within the&#xD;
             previous year&#xD;
&#xD;
          7. Subjects who have significant pain, other than or more than knee pain, including&#xD;
             significant hip, back pain, that may confound the analgesic efficacy assessments of&#xD;
             this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Alabama Clinical Therapeutics, LLC</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Terence T. Hart, MD</name>
      <address>
        <city>Tuscumbia</city>
        <state>Alabama</state>
        <zip>35674</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Clinical Research</name>
      <address>
        <city>North Hollywood</city>
        <state>California</state>
        <zip>91606</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>Artemis Institute for Clinical Research</name>
      <address>
        <city>San Marcos</city>
        <state>California</state>
        <zip>92078</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Future Care Solution, LLC</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Horizon Research Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33175</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sensible Healthcare, LLC</name>
      <address>
        <city>Ocoee</city>
        <state>Florida</state>
        <zip>34761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omega Research Consultants, LLC</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research of West Florida, Inc.</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palm Beach Research Center</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Buynak Clinical Research, P.C.</name>
      <address>
        <city>Valparaiso</city>
        <state>Indiana</state>
        <zip>46383</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heartland Research Associates, LLC</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Pharmacology Study Group</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Louis Center for Clinical Research</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Louis Clinical Trials, LC</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sundance Clinical Research, LLC</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hassman Research Institute</name>
      <address>
        <city>Berlin</city>
        <state>New Jersey</state>
        <zip>08009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</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>Medication Management, LLC</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27408</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Institute of the Carolinas of Piedmont Healthcare, PA</name>
      <address>
        <city>Mooresville</city>
        <state>North Carolina</state>
        <zip>28117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Burke Primary Care</name>
      <address>
        <city>Morganton</city>
        <state>North Carolina</state>
        <zip>28655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research Associates, LLC</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Horizons Clinical Research</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Health Partners - Center for Clinical Research</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45439</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omega Medical Research</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mountain View Clinical Research, Inc.</name>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <zip>29651</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FutureSearch Trials of Neurology</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnostics Research Group</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <results_first_submitted>October 17, 2018</results_first_submitted>
  <results_first_submitted_qc>October 17, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">November 15, 2018</results_first_posted>
  <last_update_submitted>January 25, 2019</last_update_submitted>
  <last_update_submitted_qc>January 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Osteoarthritis</keyword>
  <keyword>Pain</keyword>
  <keyword>Osteoarthritis Knee</keyword>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Naproxen</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>February 16, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/70/NCT03028870/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>January 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/70/NCT03028870/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>First subject first visit: 14-Mar-2017; last subject last visit: 21-Nov-2017. Thirty-one investigative centers in the United States participated in the study.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>V120083 30 mg</title>
          <description>V120083 30 mg taken orally twice daily</description>
        </group>
        <group group_id="P2">
          <title>V120083 60 mg</title>
          <description>V120083 60 mg taken orally twice daily</description>
        </group>
        <group group_id="P3">
          <title>Naproxen</title>
          <description>Naproxen 500 mg taken orally twice daily</description>
        </group>
        <group group_id="P4">
          <title>Placebo</title>
          <description>To match V120083 and/or naproxen taken orally twice daily</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="74"/>
                <participants group_id="P2" count="67"/>
                <participants group_id="P3" count="76"/>
                <participants group_id="P4" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="57"/>
                <participants group_id="P3" count="60"/>
                <participants group_id="P4" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
              </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="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Administrative</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="12"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The safety population (N = 291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>V120083 30 mg</title>
          <description>V120083 30 mg taken orally twice daily</description>
        </group>
        <group group_id="B2">
          <title>V120083 60 mg</title>
          <description>V120083 60 mg taken orally twice daily</description>
        </group>
        <group group_id="B3">
          <title>Naproxen</title>
          <description>Naproxen 500 mg taken orally twice daily</description>
        </group>
        <group group_id="B4">
          <title>Placebo</title>
          <description>To match V120083 and/or naproxen taken orally twice daily</description>
        </group>
        <group group_id="B5">
          <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="74"/>
            <count group_id="B2" value="67"/>
            <count group_id="B3" value="76"/>
            <count group_id="B4" value="74"/>
            <count group_id="B5" value="291"/>
          </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="60.9" spread="8.66"/>
                    <measurement group_id="B2" value="60.7" spread="8.62"/>
                    <measurement group_id="B3" value="59.8" spread="8.94"/>
                    <measurement group_id="B4" value="59.0" spread="8.97"/>
                    <measurement group_id="B5" value="60.1" spread="8.79"/>
                  </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="46"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="49"/>
                    <measurement group_id="B4" value="46"/>
                    <measurement group_id="B5" value="183"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="28"/>
                    <measurement group_id="B5" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="61"/>
                    <measurement group_id="B4" value="54"/>
                    <measurement group_id="B5" value="214"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaskan Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Daily &quot;Average Pain Over the Last 24 Hours&quot; Score at Week 4</title>
        <description>At week 4, subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.</description>
        <time_frame>Week 4</time_frame>
        <population>The full analysis population (FAP) (N = 291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>V120083 30 mg</title>
            <description>V120083 30 mg taken orally twice daily</description>
          </group>
          <group group_id="O2">
            <title>V120083 60 mg</title>
            <description>V120083 60 mg taken orally twice daily</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Naproxen 500 mg taken orally twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>To match V120083 and/or naproxen taken orally twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Daily &quot;Average Pain Over the Last 24 Hours&quot; Score at Week 4</title>
          <description>At week 4, subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.</description>
          <population>The full analysis population (FAP) (N = 291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9" spread="0.20"/>
                    <measurement group_id="O2" value="5.9" spread="0.18"/>
                    <measurement group_id="O3" value="6.1" spread="0.16"/>
                    <measurement group_id="O4" value="5.9" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="0.28"/>
                    <measurement group_id="O2" value="4.3" spread="0.28"/>
                    <measurement group_id="O3" value="3.6" spread="0.26"/>
                    <measurement group_id="O4" value="4.4" spread="0.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Weekly Change From Baseline Score of &quot;Average Pain Over the Last 24 Hours&quot; From the mBPI-SF Pain Severity Subscale</title>
        <description>Subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.</description>
        <time_frame>Weeks 1, 2 and 4</time_frame>
        <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>V120083 30 mg</title>
            <description>V120083 30 mg taken orally twice daily</description>
          </group>
          <group group_id="O2">
            <title>V120083 60 mg</title>
            <description>V120083 60 mg taken orally twice daily</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Naproxen 500 mg taken orally twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>To match V120083 and/or naproxen taken orally twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Weekly Change From Baseline Score of &quot;Average Pain Over the Last 24 Hours&quot; From the mBPI-SF Pain Severity Subscale</title>
          <description>Subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.</description>
          <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.242" spread="0.1530"/>
                    <measurement group_id="O2" value="6.431" spread="0.1408"/>
                    <measurement group_id="O3" value="6.469" spread="0.1426"/>
                    <measurement group_id="O4" value="6.543" spread="0.1497"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="75"/>
                    <count group_id="O4" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.920" spread="0.1721"/>
                    <measurement group_id="O2" value="-0.860" spread="0.1405"/>
                    <measurement group_id="O3" value="-1.655" spread="0.1789"/>
                    <measurement group_id="O4" value="-0.977" spread="0.1569"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="72"/>
                    <count group_id="O4" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.653" spread="0.2087"/>
                    <measurement group_id="O2" value="-1.336" spread="0.1998"/>
                    <measurement group_id="O3" value="-2.255" spread="0.2443"/>
                    <measurement group_id="O4" value="-1.593" spread="0.1979"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="59"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.959" spread="0.2553"/>
                    <measurement group_id="O2" value="-1.803" spread="0.2957"/>
                    <measurement group_id="O3" value="-2.741" spread="0.2898"/>
                    <measurement group_id="O4" value="-1.952" spread="0.2667"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Daily &quot;Pain Right Now&quot; Score Collected by e-Diary</title>
        <description>Subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.</description>
        <time_frame>4 Weeks</time_frame>
        <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>V120083 30 mg</title>
            <description>V120083 30 mg taken orally twice daily</description>
          </group>
          <group group_id="O2">
            <title>V120083 60 mg</title>
            <description>V120083 60 mg taken orally twice daily</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Naproxen 500 mg taken orally twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>To match V120083 and/or naproxen taken orally twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Average Daily &quot;Pain Right Now&quot; Score Collected by e-Diary</title>
          <description>Subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.</description>
          <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="43"/>
                    <count group_id="O4" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.104" spread="0.1851"/>
                    <measurement group_id="O2" value="6.737" spread="0.2076"/>
                    <measurement group_id="O3" value="6.590" spread="0.2223"/>
                    <measurement group_id="O4" value="6.481" spread="0.2587"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.366" spread="0.6400"/>
                    <measurement group_id="O2" value="7.269" spread="0.2627"/>
                    <measurement group_id="O3" value="6.000" spread="NA">Since only one subject reported a pain score, standard error was not calculated.</measurement>
                    <measurement group_id="O4" value="5.833" spread="0.7318"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale</title>
        <description>The pain subscale consisted of 5 items: walking; stair climbing; nocturnal; at rest; weight bearing. The score for each item ranged from 0 (none) to 4 (extreme). The pain subscale score was obtained by adding the responses to the 5 items which could range from 0 to 20.</description>
        <time_frame>4 Weeks</time_frame>
        <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>V120083 30 mg</title>
            <description>V120083 30 mg taken orally twice daily</description>
          </group>
          <group group_id="O2">
            <title>V120083 60 mg</title>
            <description>V120083 60 mg taken orally twice daily</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Naproxen 500 mg taken orally twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>To match V120083 and/or naproxen taken orally twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale</title>
          <description>The pain subscale consisted of 5 items: walking; stair climbing; nocturnal; at rest; weight bearing. The score for each item ranged from 0 (none) to 4 (extreme). The pain subscale score was obtained by adding the responses to the 5 items which could range from 0 to 20.</description>
          <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.2" spread="0.40"/>
                    <measurement group_id="O2" value="9.6" spread="0.34"/>
                    <measurement group_id="O3" value="9.9" spread="0.34"/>
                    <measurement group_id="O4" value="10.1" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" spread="0.50"/>
                    <measurement group_id="O2" value="7.2" spread="0.48"/>
                    <measurement group_id="O3" value="5.5" spread="0.41"/>
                    <measurement group_id="O4" value="6.8" spread="0.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale</title>
        <description>The stiffness subscale consisted of 2 items; morning stiffness and stiffness occurring later in the day. The score for each item ranged from 0 (none) to 4 (extreme) and the stiffness subscale score was obtained by adding the responses to the 2 items which could range from 0 - 8.</description>
        <time_frame>4 Weeks</time_frame>
        <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>V120083 30 mg</title>
            <description>V120083 30 mg taken orally twice daily</description>
          </group>
          <group group_id="O2">
            <title>V120083 60 mg</title>
            <description>V120083 60 mg taken orally twice daily</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Naproxen 500 mg taken orally twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>To match V120083 and/or naproxen taken orally twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale</title>
          <description>The stiffness subscale consisted of 2 items; morning stiffness and stiffness occurring later in the day. The score for each item ranged from 0 (none) to 4 (extreme) and the stiffness subscale score was obtained by adding the responses to the 2 items which could range from 0 - 8.</description>
          <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" spread="0.17"/>
                    <measurement group_id="O2" value="4.5" spread="0.18"/>
                    <measurement group_id="O3" value="4.2" spread="0.17"/>
                    <measurement group_id="O4" value="4.5" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="0.20"/>
                    <measurement group_id="O2" value="3.3" spread="0.24"/>
                    <measurement group_id="O3" value="2.6" spread="0.19"/>
                    <measurement group_id="O4" value="3.1" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale</title>
        <description>The physical function subscale consisted of 17 items: descending stairs; ascending stairs; rising from sitting; standing; bending to floor; walking on flat surface; getting into or out of car; going shopping; putting on socks; rising from bed; taking off socks; lying in bed; sitting; getting into or out of the bathtub; getting on or off the toilet; heavy domestic duties; light domestic duties. The score for each item ranged from 0 (none) to 4 (extreme) and the physical function subscale score was obtained by adding the responses to the 17 items which could range from 0 to 68.</description>
        <time_frame>4 Weeks</time_frame>
        <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>V120083 30 mg</title>
            <description>V120083 30 mg taken orally twice daily</description>
          </group>
          <group group_id="O2">
            <title>V120083 60 mg</title>
            <description>V120083 60 mg taken orally twice daily</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Naproxen 500 mg taken orally twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>To match V120083 and/or naproxen taken orally twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale</title>
          <description>The physical function subscale consisted of 17 items: descending stairs; ascending stairs; rising from sitting; standing; bending to floor; walking on flat surface; getting into or out of car; going shopping; putting on socks; rising from bed; taking off socks; lying in bed; sitting; getting into or out of the bathtub; getting on or off the toilet; heavy domestic duties; light domestic duties. The score for each item ranged from 0 (none) to 4 (extreme) and the physical function subscale score was obtained by adding the responses to the 17 items which could range from 0 to 68.</description>
          <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.6" spread="1.23"/>
                    <measurement group_id="O2" value="34.8" spread="1.13"/>
                    <measurement group_id="O3" value="33.6" spread="1.19"/>
                    <measurement group_id="O4" value="35.1" spread="1.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.6" spread="1.73"/>
                    <measurement group_id="O2" value="25.0" spread="1.79"/>
                    <measurement group_id="O3" value="18.7" spread="1.46"/>
                    <measurement group_id="O4" value="23.2" spread="1.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score</title>
        <description>The total score of the WOMAC consisted of 24 items (5 items from the pain subscale, 2 items from the stiffness subscale, and 17 items from the physical function subscale). The total score was obtained by adding the scores from these 3 subscales and could range from 0 to 96.</description>
        <time_frame>4 Weeks</time_frame>
        <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>V120083 30 mg</title>
            <description>V120083 30 mg taken orally twice daily</description>
          </group>
          <group group_id="O2">
            <title>V120083 60 mg</title>
            <description>V120083 60 mg taken orally twice daily</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Naproxen 500 mg taken orally twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>To match V120083 and/or naproxen taken orally twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score</title>
          <description>The total score of the WOMAC consisted of 24 items (5 items from the pain subscale, 2 items from the stiffness subscale, and 17 items from the physical function subscale). The total score was obtained by adding the scores from these 3 subscales and could range from 0 to 96.</description>
          <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.3" spread="1.67"/>
                    <measurement group_id="O2" value="48.9" spread="1.54"/>
                    <measurement group_id="O3" value="47.6" spread="1.55"/>
                    <measurement group_id="O4" value="49.6" spread="1.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.8" spread="2.35"/>
                    <measurement group_id="O2" value="35.5" spread="2.45"/>
                    <measurement group_id="O3" value="26.8" spread="1.99"/>
                    <measurement group_id="O4" value="33.1" spread="2.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Score (All Parts of 6 Questions)</title>
        <description>The mBPI-SF consists of 6 questions and is a self-administered questionnaire used to assess the severity of pain, and the interference of pain on daily functions. Subjects rated their severity of pain / interference of pain on a 0 (no pain / does not interfere) to 10 (as bad as you can imagine / completely interferes) numerical rating scale (NRS) The total score is the sum of all parts of the 6 questions and the total score range is 0 - 110.</description>
        <time_frame>4 Weeks</time_frame>
        <population>The FAP (N = 291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>V120083 30 mg</title>
            <description>V120083 30 mg taken orally twice daily</description>
          </group>
          <group group_id="O2">
            <title>V120083 60 mg</title>
            <description>V120083 60 mg taken orally twice daily</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Naproxen 500 mg taken orally twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>To match V120083 and/or naproxen taken orally twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Score (All Parts of 6 Questions)</title>
          <description>The mBPI-SF consists of 6 questions and is a self-administered questionnaire used to assess the severity of pain, and the interference of pain on daily functions. Subjects rated their severity of pain / interference of pain on a 0 (no pain / does not interfere) to 10 (as bad as you can imagine / completely interferes) numerical rating scale (NRS) The total score is the sum of all parts of the 6 questions and the total score range is 0 - 110.</description>
          <population>The FAP (N = 291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.5" spread="2.49"/>
                    <measurement group_id="O2" value="53.4" spread="2.30"/>
                    <measurement group_id="O3" value="56.0" spread="1.90"/>
                    <measurement group_id="O4" value="53.1" spread="2.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.5" spread="2.97"/>
                    <measurement group_id="O2" value="35.3" spread="3.03"/>
                    <measurement group_id="O3" value="28.5" spread="2.51"/>
                    <measurement group_id="O4" value="35.7" spread="3.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score</title>
        <description>The mBPI-SF is a self-administered questionnaire. The pain severity subscale of the mBPI-SF consists of 4 questions which ask the subjects to rate their severity of pain on a 0 to 10 NRS for worst pain, least pain, average pain, and current pain. The severity of pain was computed as the mean of questions 1-4. The mean severity of pain scores could range from 0 to 10.</description>
        <time_frame>4 Weeks</time_frame>
        <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>V120083 30 mg</title>
            <description>V120083 30 mg taken orally twice daily</description>
          </group>
          <group group_id="O2">
            <title>V120083 60 mg</title>
            <description>V120083 60 mg taken orally twice daily</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Naproxen 500 mg taken orally twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>To match V120083 and/or naproxen taken orally twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score</title>
          <description>The mBPI-SF is a self-administered questionnaire. The pain severity subscale of the mBPI-SF consists of 4 questions which ask the subjects to rate their severity of pain on a 0 to 10 NRS for worst pain, least pain, average pain, and current pain. The severity of pain was computed as the mean of questions 1-4. The mean severity of pain scores could range from 0 to 10.</description>
          <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.784" spread="0.2068"/>
                    <measurement group_id="O2" value="5.739" spread="0.1935"/>
                    <measurement group_id="O3" value="5.747" spread="0.1525"/>
                    <measurement group_id="O4" value="5.801" spread="0.1978"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.139" spread="0.2840"/>
                    <measurement group_id="O2" value="4.135" spread="0.2771"/>
                    <measurement group_id="O3" value="3.510" spread="0.2543"/>
                    <measurement group_id="O4" value="4.308" spread="0.2900"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score</title>
        <description>The mBPI-SF is a self-administered questionnaire. The pain interference subscale of the mBPI-SF consists of Question 6 which has 7 parts, all of which ask the subjects to rate the impact/interference of their pain on various functions, ie, general activity, mood, walking, normal work, relations with others, sleep, and enjoyment of life on a 0 to 10 NRS where 0 = does not interfere and 10 = completely interferes. The mean interference of pain scores could range from 0 to 10.</description>
        <time_frame>4 Weeks</time_frame>
        <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>V120083 30 mg</title>
            <description>V120083 30 mg taken orally twice daily</description>
          </group>
          <group group_id="O2">
            <title>V120083 60 mg</title>
            <description>V120083 60 mg taken orally twice daily</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Naproxen 500 mg taken orally twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>To match V120083 and/or naproxen taken orally twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score</title>
          <description>The mBPI-SF is a self-administered questionnaire. The pain interference subscale of the mBPI-SF consists of Question 6 which has 7 parts, all of which ask the subjects to rate the impact/interference of their pain on various functions, ie, general activity, mood, walking, normal work, relations with others, sleep, and enjoyment of life on a 0 to 10 NRS where 0 = does not interfere and 10 = completely interferes. The mean interference of pain scores could range from 0 to 10.</description>
          <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.618" spread="0.2717"/>
                    <measurement group_id="O2" value="4.348" spread="0.2573"/>
                    <measurement group_id="O3" value="4.718" spread="0.2186"/>
                    <measurement group_id="O4" value="4.278" spread="0.2721"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.847" spread="0.2925"/>
                    <measurement group_id="O2" value="2.679" spread="0.2961"/>
                    <measurement group_id="O3" value="2.070" spread="0.2377"/>
                    <measurement group_id="O4" value="2.634" spread="0.3049"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Responder to Treatment (Calculated as the Percentage Reduction of &quot;Average Pain Over the Last 24 Hours&quot;) at Week 4</title>
        <description>A subject's response to treatment was defined as the percentage reduction from the baseline &quot;average pain over the last 24 hours&quot; score to the week 4 pain score from the mBPI-SF pain severity subscale. Responders were defined as having &gt; 0 % reduction; non-responders were defined as having ≤ 0% reduction.</description>
        <time_frame>Week 4</time_frame>
        <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>V120083 30 mg</title>
            <description>V120083 30 mg taken orally twice daily</description>
          </group>
          <group group_id="O2">
            <title>V120083 60 mg</title>
            <description>V120083 60 mg taken orally twice daily</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Naproxen 500 mg taken orally twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>To match V120083 and/or naproxen taken orally twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Responder to Treatment (Calculated as the Percentage Reduction of &quot;Average Pain Over the Last 24 Hours&quot;) at Week 4</title>
          <description>A subject's response to treatment was defined as the percentage reduction from the baseline &quot;average pain over the last 24 hours&quot; score to the week 4 pain score from the mBPI-SF pain severity subscale. Responders were defined as having &gt; 0 % reduction; non-responders were defined as having ≤ 0% reduction.</description>
          <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Responder - Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="42"/>
                    <measurement group_id="O3" value="57"/>
                    <measurement group_id="O4" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Responder - No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="19"/>
                    <measurement group_id="O4" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary</title>
        <description>The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH).&#xD;
The Physical Component Summary is derived from 4 of the 8 health dimensions (aggregate of PF, RP, BP, and GH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state.</description>
        <time_frame>4 Weeks</time_frame>
        <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>V120083 30 mg</title>
            <description>V120083 30 mg taken orally twice daily</description>
          </group>
          <group group_id="O2">
            <title>V120083 60 mg</title>
            <description>V120083 60 mg taken orally twice daily</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Naproxen 500 mg taken orally twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>To match V120083 and/or naproxen taken orally twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary</title>
          <description>The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH).&#xD;
The Physical Component Summary is derived from 4 of the 8 health dimensions (aggregate of PF, RP, BP, and GH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state.</description>
          <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.689" spread="0.9696"/>
                    <measurement group_id="O2" value="31.629" spread="0.9146"/>
                    <measurement group_id="O3" value="32.348" spread="1.0737"/>
                    <measurement group_id="O4" value="33.762" spread="1.0315"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.515" spread="1.3008"/>
                    <measurement group_id="O2" value="36.277" spread="1.3584"/>
                    <measurement group_id="O3" value="39.372" spread="1.2486"/>
                    <measurement group_id="O4" value="37.826" spread="1.1440"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Medical Outcomes Study Short Form-36 (SF-36) - Mental Component Summary</title>
        <description>The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH).&#xD;
The Mental Component Summary is derived from 4 of the 8 health dimensions,(aggregate of VT, SF, RE, and MH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state.</description>
        <time_frame>4 Weeks</time_frame>
        <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>V120083 30 mg</title>
            <description>V120083 30 mg taken orally twice daily</description>
          </group>
          <group group_id="O2">
            <title>V120083 60 mg</title>
            <description>V120083 60 mg taken orally twice daily</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Naproxen 500 mg taken orally twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>To match V120083 and/or naproxen taken orally twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Medical Outcomes Study Short Form-36 (SF-36) - Mental Component Summary</title>
          <description>The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH).&#xD;
The Mental Component Summary is derived from 4 of the 8 health dimensions,(aggregate of VT, SF, RE, and MH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state.</description>
          <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.248" spread="0.9688"/>
                    <measurement group_id="O2" value="59.766" spread="1.1498"/>
                    <measurement group_id="O3" value="60.450" spread="0.8714"/>
                    <measurement group_id="O4" value="59.450" spread="1.0132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.596" spread="0.9615"/>
                    <measurement group_id="O2" value="59.560" spread="1.0785"/>
                    <measurement group_id="O3" value="60.921" spread="0.7819"/>
                    <measurement group_id="O4" value="60.948" spread="0.8835"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>European Quality of Life Scale - 5 Dimensions (EQ-5D-5L) to Measure Health Status</title>
        <description>EQ-5D-5L is a standardized generic measure of health status for clinical and economic appraisal based on a descriptive system that defines health in terms of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It includes a visual analogue scale (VAS) with scores ranging from 0 (&quot;worst imaginable health state&quot;) to 100 (&quot;best imaginable health state&quot;).</description>
        <time_frame>4 Weeks</time_frame>
        <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>V120083 30 mg</title>
            <description>V120083 30 mg taken orally twice daily</description>
          </group>
          <group group_id="O2">
            <title>V120083 60 mg</title>
            <description>V120083 60 mg taken orally twice daily</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Naproxen 500 mg taken orally twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>To match V120083 and/or naproxen taken orally twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>European Quality of Life Scale - 5 Dimensions (EQ-5D-5L) to Measure Health Status</title>
          <description>EQ-5D-5L is a standardized generic measure of health status for clinical and economic appraisal based on a descriptive system that defines health in terms of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It includes a visual analogue scale (VAS) with scores ranging from 0 (&quot;worst imaginable health state&quot;) to 100 (&quot;best imaginable health state&quot;).</description>
          <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline VAS Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.2" spread="2.04"/>
                    <measurement group_id="O2" value="72.9" spread="1.94"/>
                    <measurement group_id="O3" value="75.4" spread="1.88"/>
                    <measurement group_id="O4" value="74.6" spread="1.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 VAS Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.0" spread="2.17"/>
                    <measurement group_id="O2" value="77.4" spread="2.42"/>
                    <measurement group_id="O3" value="83.7" spread="1.37"/>
                    <measurement group_id="O4" value="81.4" spread="1.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Global Impression of Change (PGIC)</title>
        <description>The PGIC is an ordinal scale which assesses the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse), where 1 = very much improved and 7 = very much worse. The number of subjects responding &quot;very much improved&quot; and &quot;much improved&quot; was summarized by treatment group.</description>
        <time_frame>4 Weeks</time_frame>
        <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>V120083 30 mg</title>
            <description>V120083 30 mg taken orally twice daily</description>
          </group>
          <group group_id="O2">
            <title>V120083 60 mg</title>
            <description>V120083 60 mg taken orally twice daily</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Naproxen 500 mg taken orally twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>To match V120083 and/or naproxen taken orally twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Impression of Change (PGIC)</title>
          <description>The PGIC is an ordinal scale which assesses the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse), where 1 = very much improved and 7 = very much worse. The number of subjects responding &quot;very much improved&quot; and &quot;much improved&quot; was summarized by treatment group.</description>
          <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Subjects Completing PGIC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="65"/>
                    <measurement group_id="O3" value="76"/>
                    <measurement group_id="O4" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects Responding 'Very Much' / 'Much' Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="38"/>
                    <measurement group_id="O4" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Supplemental Analgesic Medication Use</title>
        <description>The average daily number of tablets of supplemental pain medication used during the double-blind period was summarized by treatment group.</description>
        <time_frame>Up to 28 days</time_frame>
        <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>V120083 30 mg</title>
            <description>V120083 30 mg taken orally twice daily</description>
          </group>
          <group group_id="O2">
            <title>V120083 60 mg</title>
            <description>V120083 60 mg taken orally twice daily</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Naproxen 500 mg taken orally twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>To match V120083 and/or naproxen taken orally twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Supplemental Analgesic Medication Use</title>
          <description>The average daily number of tablets of supplemental pain medication used during the double-blind period was summarized by treatment group.</description>
          <population>The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.</population>
          <units>Supplemental Analgesic Tablets</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="35"/>
                <count group_id="O3" value="34"/>
                <count group_id="O4" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.779" spread="0.1471"/>
                    <measurement group_id="O2" value="0.686" spread="0.1187"/>
                    <measurement group_id="O3" value="0.378" spread="0.0712"/>
                    <measurement group_id="O4" value="0.670" spread="0.1205"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS)</title>
        <description>Suicidality was monitored throughout the study using the C-SSRS. The C-SSRS involves a series of probing questions to inquire about possible suicidal thinking and behavior. The composite endpoints (Suicidal Ideation, Suicidal Behavior, Suicidal Ideation or Behavior) included subjects who experienced any one of the events at least once during treatment.</description>
        <time_frame>Baseline up to 4 Weeks</time_frame>
        <population>The safety population (N = 291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>V120083 30 mg</title>
            <description>V120083 30 mg taken orally twice daily</description>
          </group>
          <group group_id="O2">
            <title>V120083 60 mg</title>
            <description>V120083 60 mg taken orally twice daily</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Naproxen 500 mg taken orally twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>To match V120083 and/or naproxen taken orally twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS)</title>
          <description>Suicidality was monitored throughout the study using the C-SSRS. The C-SSRS involves a series of probing questions to inquire about possible suicidal thinking and behavior. The composite endpoints (Suicidal Ideation, Suicidal Behavior, Suicidal Ideation or Behavior) included subjects who experienced any one of the events at least once during treatment.</description>
          <population>The safety population (N = 291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Suicidal ideation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Suicidal behavior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Suicidal ideation or behavior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self-injurious behavior without suicidal intent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 4 in Hospital Anxiety and Depression Scale (HADS) Score</title>
        <description>Safety assessment to evaluate the impact of V120083 on mood (anxiety [HADS-A] and depression [HADS-D]). The score for each subscale ranges from 0 (no anxiety or depression) to 21, with a score of 11 or higher indicating the probable presence of the mood disorder.</description>
        <time_frame>Week 4</time_frame>
        <population>The safety population (N = 291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>V120083 30 mg</title>
            <description>V120083 30 mg taken orally twice daily</description>
          </group>
          <group group_id="O2">
            <title>V120083 60 mg</title>
            <description>V120083 60 mg taken orally twice daily</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Naproxen 500 mg taken orally twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>To match V120083 and/or naproxen taken orally twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 4 in Hospital Anxiety and Depression Scale (HADS) Score</title>
          <description>Safety assessment to evaluate the impact of V120083 on mood (anxiety [HADS-A] and depression [HADS-D]). The score for each subscale ranges from 0 (no anxiety or depression) to 21, with a score of 11 or higher indicating the probable presence of the mood disorder.</description>
          <population>The safety population (N = 291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4 change from baseline - HADS-A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="0.26"/>
                    <measurement group_id="O2" value="-0.3" spread="0.26"/>
                    <measurement group_id="O3" value="-0.4" spread="0.30"/>
                    <measurement group_id="O4" value="-0.6" spread="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 change from baseline - HADS-D</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.25"/>
                    <measurement group_id="O2" value="0.6" spread="0.31"/>
                    <measurement group_id="O3" value="-0.2" spread="0.29"/>
                    <measurement group_id="O4" value="-0.1" spread="0.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.</time_frame>
      <desc>AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.</desc>
      <group_list>
        <group group_id="E1">
          <title>V120083 30 mg</title>
          <description>V120083 30 mg taken orally twice daily</description>
        </group>
        <group group_id="E2">
          <title>V120083 60 mg</title>
          <description>V120083 60 mg taken orally twice daily</description>
        </group>
        <group group_id="E3">
          <title>Naproxen</title>
          <description>Naproxen 500 mg taken orally twice daily</description>
        </group>
        <group group_id="E4">
          <title>Placebo</title>
          <description>To match V120083 and/or naproxen taken orally twice daily</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (19.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delerium tremens</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (19.1)</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="18" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="67"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="76"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="67"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="76"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="76"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="67"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="67"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="67"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="76"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="74"/>
              </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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Leader</name_or_title>
      <organization>Purdue Pharma L.P.</organization>
      <phone>1-800-733-1333</phone>
      <email>steven.ripa@pharma.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/NCT03028870
org study id: VAN2001
nct id: NCT03028870
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the analgesic efficacy of V120083 twice daily
      compared to placebo in subjects with moderate to severe chronic pain due to OA of the knee.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Daily "Average Pain Over the Last 24 Hours" Score at Week 4
time frame: Week 4
description: At week 4, subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.
measure: Weekly Change From Baseline Score of "Average Pain Over the Last 24 Hours" From the mBPI-SF Pain Severity Subscale
time frame: Weeks 1, 2 and 4
description: Subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.
measure: Average Daily "Pain Right Now" Score Collected by e-Diary
time frame: 4 Weeks
description: Subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.
measure: Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale
time frame: 4 Weeks
description: The pain subscale consisted of 5 items: walking; stair climbing; nocturnal; at rest; weight bearing. The score for each item ranged from 0 (none) to 4 (extreme). The pain subscale score was obtained by adding the responses to the 5 items which could range from 0 to 20.
measure: Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale
time frame: 4 Weeks
description: The stiffness subscale consisted of 2 items; morning stiffness and stiffness occurring later in the day. The score for each item ranged from 0 (none) to 4 (extreme) and the stiffness subscale score was obtained by adding the responses to the 2 items which could range from 0 - 8.
measure: Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale
time frame: 4 Weeks
description: The physical function subscale consisted of 17 items: descending stairs; ascending stairs; rising from sitting; standing; bending to floor; walking on flat surface; getting into or out of car; going shopping; putting on socks; rising from bed; taking off socks; lying in bed; sitting; getting into or out of the bathtub; getting on or off the toilet; heavy domestic duties; light domestic duties. The score for each item ranged from 0 (none) to 4 (extreme) and the physical function subscale score was obtained by adding the responses to the 17 items which could range from 0 to 68.
measure: Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score
time frame: 4 Weeks
description: The total score of the WOMAC consisted of 24 items (5 items from the pain subscale, 2 items from the stiffness subscale, and 17 items from the physical function subscale). The total score was obtained by adding the scores from these 3 subscales and could range from 0 to 96.
measure: Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Score (All Parts of 6 Questions)
time frame: 4 Weeks
description: The mBPI-SF consists of 6 questions and is a self-administered questionnaire used to assess the severity of pain, and the interference of pain on daily functions. Subjects rated their severity of pain / interference of pain on a 0 (no pain / does not interfere) to 10 (as bad as you can imagine / completely interferes) numerical rating scale (NRS) The total score is the sum of all parts of the 6 questions and the total score range is 0 - 110.
measure: Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score
time frame: 4 Weeks
description: The mBPI-SF is a self-administered questionnaire. The pain severity subscale of the mBPI-SF consists of 4 questions which ask the subjects to rate their severity of pain on a 0 to 10 NRS for worst pain, least pain, average pain, and current pain. The severity of pain was computed as the mean of questions 1-4. The mean severity of pain scores could range from 0 to 10.
measure: Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score
time frame: 4 Weeks
description: The mBPI-SF is a self-administered questionnaire. The pain interference subscale of the mBPI-SF consists of Question 6 which has 7 parts, all of which ask the subjects to rate the impact/interference of their pain on various functions, ie, general activity, mood, walking, normal work, relations with others, sleep, and enjoyment of life on a 0 to 10 NRS where 0 = does not interfere and 10 = completely interferes. The mean interference of pain scores could range from 0 to 10.
measure: Responder to Treatment (Calculated as the Percentage Reduction of "Average Pain Over the Last 24 Hours") at Week 4
time frame: Week 4
description: A subject's response to treatment was defined as the percentage reduction from the baseline "average pain over the last 24 hours" score to the week 4 pain score from the mBPI-SF pain severity subscale. Responders were defined as having > 0 % reduction; non-responders were defined as having ≤ 0% reduction.
measure: Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary
time frame: 4 Weeks
description: The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH).
The Physical Component Summary is derived from 4 of the 8 health dimensions (aggregate of PF, RP, BP, and GH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state.
measure: Medical Outcomes Study Short Form-36 (SF-36) - Mental Component Summary
time frame: 4 Weeks
description: The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH).
The Mental Component Summary is derived from 4 of the 8 health dimensions,(aggregate of VT, SF, RE, and MH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state.
measure: European Quality of Life Scale - 5 Dimensions (EQ-5D-5L) to Measure Health Status
time frame: 4 Weeks
description: EQ-5D-5L is a standardized generic measure of health status for clinical and economic appraisal based on a descriptive system that defines health in terms of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It includes a visual analogue scale (VAS) with scores ranging from 0 ("worst imaginable health state") to 100 ("best imaginable health state").
measure: Patient Global Impression of Change (PGIC)
time frame: 4 Weeks
description: The PGIC is an ordinal scale which assesses the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse), where 1 = very much improved and 7 = very much worse. The number of subjects responding "very much improved" and "much improved" was summarized by treatment group.
measure: Supplemental Analgesic Medication Use
time frame: Up to 28 days
description: The average daily number of tablets of supplemental pain medication used during the double-blind period was summarized by treatment group.
measure: Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS)
time frame: Baseline up to 4 Weeks
description: Suicidality was monitored throughout the study using the C-SSRS. The C-SSRS involves a series of probing questions to inquire about possible suicidal thinking and behavior. The composite endpoints (Suicidal Ideation, Suicidal Behavior, Suicidal Ideation or Behavior) included subjects who experienced any one of the events at least once during treatment.
measure: Change From Baseline to Week 4 in Hospital Anxiety and Depression Scale (HADS) Score
time frame: Week 4
description: Safety assessment to evaluate the impact of V120083 on mood (anxiety [HADS-A] and depression [HADS-D]). The score for each subscale ranges from 0 (no anxiety or depression) to 21, with a score of 11 or higher indicating the probable presence of the mood disorder.
arm group label: V120083 30 mg
arm group type: Experimental
description: V120083 30-mg capsules taken orally twice daily
arm group label: V120083 60 mg
arm group type: Experimental
description: V120083 60-mg (2 x 30 mg) capsules taken orally twice daily
arm group label: Naproxen
arm group type: Active Comparator
description: Naproxen 500-mg capsules taken orally twice daily
arm group label: Placebo
arm group type: Placebo Comparator
description: Capsules to match V120083 and/or naproxen taken orally twice daily
intervention type: Drug
intervention name: V120083
description: Capsules
arm group label: V120083 30 mg
arm group label: V120083 60 mg
intervention type: Drug
intervention name: Naproxen
description: Capsules
arm group label: Naproxen
intervention type: Drug
intervention name: Placebo
description: Capsules to match V120083 and/or naproxen
arm group label: Naproxen
arm group label: Placebo
arm group label: V120083 30 mg
arm group label: V120083 60 mg
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Naproxen
sharing ipd: No
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