<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/NCT01688934</url>
  </required_header>
  <id_info>
    <org_study_id>VND2001</org_study_id>
    <nct_id>NCT01688934</nct_id>
  </id_info>
  <brief_title>Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis (OA) of the Knee</brief_title>
  <official_title>A Phase 2, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Study Evaluating the Analgesic Efficacy and Safety of V116517 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>
  </sponsors>
  <source>Purdue Pharma LP</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of&#xD;
      V116517 versus placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</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>Western Ontario and McMaster OA Index (WOMAC) Pain Score</measure>
    <time_frame>Week 4</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>WOMAC Physical Function Score</measure>
    <time_frame>Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WOMAC Stiffness Score</measure>
    <time_frame>Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Brief Pain Inventory - Short Form (mBPI-SF) Severity of Pain and Interference of Pain</measure>
    <time_frame>Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change (PGIC)</measure>
    <time_frame>Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Supplemental Analgesic Medication Use</measure>
    <time_frame>Over 4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">230</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>V116517 - 50 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>V116517 50-mg tablets</description>
  </arm_group>
  <arm_group>
    <arm_group_label>V116517 - 30 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>V116517 30-mg tablets</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Naproxen 500 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Naproxen 500-mg capsules</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>V116517 50-mg tablets</intervention_name>
    <description>Taken orally twice daily</description>
    <arm_group_label>V116517 - 50 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>V116517 30-mg tablets</intervention_name>
    <description>Taken orally twice daily</description>
    <arm_group_label>V116517 - 30 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Naproxen 500-mg capsules</intervention_name>
    <description>Taken orally twice daily</description>
    <arm_group_label>Naproxen 500 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Tablets to match V116517 and/or placebo capsules to match naproxen taken orally twice daily</description>
    <arm_group_label>Naproxen 500 mg</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>V116517 - 30 mg</arm_group_label>
    <arm_group_label>V116517 - 50 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          1. Subjects with moderate pain due to OA of the knee as their primary pain condition.&#xD;
&#xD;
          2. Subjects with diagnostic criteria for primary pain condition (American college of&#xD;
             Rheumatology [ACR] clinical and radiographic criteria):&#xD;
&#xD;
               -  At least 1 of the following in addition to knee pain: age &gt;50, stiffness &lt;30 min,&#xD;
                  crepitus on active motion, and&#xD;
&#xD;
               -  Kellgren-Lawrence (K-L) grade ≥ 2 radiographic evidence within the past 2 years.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with chronic pain conditions other than OA of the knee as their predominant&#xD;
             pain condition, including gout, pseudo gout, 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;
          2. Subjects who cannot or will not agree to stop all concomitant analgesic medications,&#xD;
             apart from specified protocol supplemental analgesic medications.&#xD;
&#xD;
          3. Subjects with history of seizures within the past 5 years.&#xD;
&#xD;
          4. Subjects who use opioids more than 4 days per week.&#xD;
&#xD;
          5. Pain-condition-specific exclusions:&#xD;
&#xD;
               -  Subjects who received local pain-control procedures, including intra- articular&#xD;
                  steroid injection in the study knee or intramuscular steroid injection at any&#xD;
                  site within 6 weeks of entering the study or hyaluronate injection in the study&#xD;
                  knee within 12 weeks of entering the study.&#xD;
&#xD;
          6. 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;
          7. Active-comparator-related exclusions:&#xD;
&#xD;
               -  Subjects who are allergic to or cannot tolerate naproxen or acetaminophen,&#xD;
                  including history of NSAID-induced asthma, or nasal polyps;&#xD;
&#xD;
               -  Subjects with history of bleeding disorders or history of documented&#xD;
                  gastrointestinal ulcer disease.&#xD;
&#xD;
        Other protocol specific inclusion/exclusion criteria may apply.&#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>Genova Clinical Research, Inc.</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopedic Research Institute</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33472</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avail Clinical Research, LLC</name>
      <address>
        <city>Deland</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westside Center for Clinical Research</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jacksonville Center for Clinical Research</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Awareness, Inc.</name>
      <address>
        <city>Jupiter</city>
        <state>Florida</state>
        <zip>33458</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Compass Research, LLC</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Compass Research East, LLC</name>
      <address>
        <city>Oviedo</city>
        <state>Florida</state>
        <zip>32765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Indiana Center for Clinical Research</name>
      <address>
        <city>Valparaiso</city>
        <state>Indiana</state>
        <zip>46383</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Analgesic Solutions</name>
      <address>
        <city>Natick</city>
        <state>Massachusetts</state>
        <zip>01760</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Research Group, Inc.</name>
      <address>
        <city>Bay City</city>
        <state>Michigan</state>
        <zip>48706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Charlotte, LLC.</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Raleigh, LLC</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27609</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>LION Research</name>
      <address>
        <city>Norman</city>
        <state>Oklahoma</state>
        <zip>73069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altoona Center for Clinical Research</name>
      <address>
        <city>Duncansville</city>
        <state>Pennsylvania</state>
        <zip>16635</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Center of Reading, LLP</name>
      <address>
        <city>Wyomissing</city>
        <state>Pennsylvania</state>
        <zip>19610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Bristol</name>
      <address>
        <city>Bristol</city>
        <state>Tennessee</state>
        <zip>37620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <last_update_submitted>December 4, 2013</last_update_submitted>
  <last_update_submitted_qc>December 4, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 5, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pain</keyword>
  <keyword>Osteoarthritis</keyword>
  <keyword>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>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Naproxen</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01688934
org study id: VND2001
nct id: NCT01688934
lead sponsor: 
has dmc: Yes
The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of
      V116517 versus placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Western Ontario and McMaster OA Index (WOMAC) Pain Score
time frame: Week 4
measure: WOMAC Physical Function Score
time frame: Week 4
measure: WOMAC Stiffness Score
time frame: Week 4
measure: Modified Brief Pain Inventory - Short Form (mBPI-SF) Severity of Pain and Interference of Pain
time frame: Week 4
measure: Patient Global Impression of Change (PGIC)
time frame: Week 4
measure: Supplemental Analgesic Medication Use
time frame: Over 4 weeks
arm group label: V116517 - 50 mg
arm group type: Experimental
description: V116517 50-mg tablets
arm group label: V116517 - 30 mg
arm group type: Experimental
description: V116517 30-mg tablets
arm group label: Naproxen 500 mg
arm group type: Active Comparator
description: Naproxen 500-mg capsules
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: V116517 50-mg tablets
description: Taken orally twice daily
arm group label: V116517 - 50 mg
intervention type: Drug
intervention name: V116517 30-mg tablets
description: Taken orally twice daily
arm group label: V116517 - 30 mg
intervention type: Drug
intervention name: Naproxen 500-mg capsules
description: Taken orally twice daily
arm group label: Naproxen 500 mg
intervention type: Drug
intervention name: Placebo
description: Tablets to match V116517 and/or placebo capsules to match naproxen taken orally twice daily
arm group label: Naproxen 500 mg
arm group label: Placebo
arm group label: V116517 - 30 mg
arm group label: V116517 - 50 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: Chronic Pain
mesh term: Naproxen