<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/NCT01688947</url>
  </required_header>
  <id_info>
    <org_study_id>VND2002</org_study_id>
    <nct_id>NCT01688947</nct_id>
  </id_info>
  <brief_title>Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Postherpetic Neuralgia (PHN)</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 Postherpetic Neuralgia (PHN)</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>No</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">April 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</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>&quot;Pain on the average in the last 24 hours&quot; score from the Modified Brief Pain Inventory - Short Form (mBPI-SF)</measure>
    <time_frame>Week 4</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>mBPI-SF severity of pain (parameters including average pain, worst pain, least pain, pain right now) and interference of pain (all parts of question 6)</measure>
    <time_frame>Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropathic Pain Symptom Inventory (NPSI)</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">105</enrollment>
  <condition>Postherpetic Neuralgia</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>Pregabalin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pregabalin 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>Pregabalin capsules</intervention_name>
    <description>1-2 capsules taken orally twice daily</description>
    <arm_group_label>Pregabalin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Pregabalin</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 chronic pain due to PHN as their primary pain condition and some degree&#xD;
             of pain every day from this condition.&#xD;
&#xD;
          2. Clinical diagnosis of PHN based on history of painful dermatomal blistering rash&#xD;
             resolving in a few weeks followed by persistent pain in the same region of ≥ 3 months&#xD;
             duration.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with chronic pain conditions other than PHN as their predominant pain&#xD;
             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 a recent history of seizure within the past 5 years.&#xD;
&#xD;
          4. Subjects who use opioids more than 4 days per week.&#xD;
&#xD;
          5. Subjects with clinically unstable medical conditions, including cardiac disease&#xD;
             (unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart&#xD;
             failure, or active myocardial ischemia); respiratory disease; biliary tract disease;&#xD;
             hypothyroidism; adrenal cortical insufficiency; or any other medical condition that in&#xD;
             the investigator's opinion is inadequately treated and precludes entry into the study.&#xD;
&#xD;
          6. Subjects with a history of suicide attempts, or subjects clinically judged by the&#xD;
             principal investigator (PI) to be at serious risk of suicide.&#xD;
&#xD;
          7. PHN-pain-condition-specific exclusions:&#xD;
&#xD;
               -  Subjects who received pain-control interventions including neurolytic blocks or&#xD;
                  neurosurgical procedures to the affected nerve or spinal cord segment, spinal&#xD;
                  cord, stimulators, or neuraxial infusion pumps.&#xD;
&#xD;
          8. Active-comparator-related exclusions:&#xD;
&#xD;
               -  Subjects who are allergic to or cannot tolerate pregabalin or acetaminophen.&#xD;
&#xD;
        Other protocol specific inclusion/exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037-7651</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>North Hollywood</city>
        <state>California</state>
        <zip>91606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Deland</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33916</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Lynn Haven</city>
        <state>Florida</state>
        <zip>32444</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>North Miami</city>
        <state>Florida</state>
        <zip>33161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Oviedo</city>
        <state>Florida</state>
        <zip>32765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Palm Beach Gardens</city>
        <state>Florida</state>
        <zip>33410</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>St. Petersburg</city>
        <state>Florida</state>
        <zip>33716</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Sunrise</city>
        <state>Florida</state>
        <zip>33351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60634</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Prairie Village</city>
        <state>Kansas</state>
        <zip>66206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>New Bedford</city>
        <state>Massachusetts</state>
        <zip>02740</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Bay City</city>
        <state>Michigan</state>
        <zip>48706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Bingham Farms</city>
        <state>Michigan</state>
        <zip>48025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Pinconning</city>
        <state>Michigan</state>
        <zip>48650</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2014</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>May 9, 2014</last_update_submitted>
  <last_update_submitted_qc>May 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pain</keyword>
  <keyword>Neuralgia, Postherpetic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
    <mesh_term>Neuralgia, Postherpetic</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>Pregabalin</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/NCT01688947
org study id: VND2002
nct id: NCT01688947
lead sponsor: 
has dmc: No
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: "Pain on the average in the last 24 hours" score from the Modified Brief Pain Inventory - Short Form (mBPI-SF)
time frame: Week 4
measure: mBPI-SF severity of pain (parameters including average pain, worst pain, least pain, pain right now) and interference of pain (all parts of question 6)
time frame: Week 4
measure: Neuropathic Pain Symptom Inventory (NPSI)
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: Pregabalin
arm group type: Active Comparator
description: Pregabalin 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: Pregabalin capsules
description: 1-2 capsules taken orally twice daily
arm group label: Pregabalin
intervention type: Drug
intervention name: Placebo
description: Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily
arm group label: Placebo
arm group label: Pregabalin
arm group label: V116517 - 30 mg
arm group label: V116517 - 50 mg
criteria: 
gender: All
minimum age: 21 Years
maximum age: 90 Years
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Neuralgia
mesh term: Neuralgia, Postherpetic
mesh term: Chronic Pain
mesh term: Pregabalin