<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/NCT02215252</url>
  </required_header>
  <id_info>
    <org_study_id>B3291026</org_study_id>
    <secondary_id>DPN NAV1.7</secondary_id>
    <nct_id>NCT02215252</nct_id>
  </id_info>
  <brief_title>A Clinical Trial To Evaluate PF-05089771 On Its Own And As An Add-On Therapy To Pregabalin (Lyrica) For The Treatment Of Pain Due To Diabetic Peripheral Neuropathy (DPN)</brief_title>
  <official_title>A Randomized Double Blind Placebo And Active Controlled Parallel Group Phase 2 Study To Evaluate PF-05089771 As A Monotherapy And As An Add-on To Pregabalin For The Treatment Of Painful Diabetic Peripheral Neuropathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and safety of PF-05089771 as a&#xD;
      monotherapy and as an add-on to pregabalin for the treatment of painful diabetic peripheral&#xD;
      neuropathy (DPN)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 10, 2014</start_date>
  <completion_date type="Actual">September 28, 2015</completion_date>
  <primary_completion_date type="Actual">July 15, 2015</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 Pain Numeric Rating Scale (NRS)</measure>
    <time_frame>Baseline, Week 1, Week 2, Week 3 and Week 4</time_frame>
    <description>The endpoint average pain score, based on the mean of the last 7 days' daily pain numeric rating scale (NRS) scores at (NRS is an 11-point scale where 0 = no pain and 10 = worst possible pain) from the daily pain diaries while receiving study medication during the treatment period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score</measure>
    <time_frame>Baseline, Week 1, Week 2, Week 3 and Week 4</time_frame>
    <description>Percentage of participants that received ≥30% improvement from baseline in mean pain response (from the daily pain diary).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score</measure>
    <time_frame>Baseline, Week 1, Week 2, Week 3, and Week 4</time_frame>
    <description>Percentage of participants that received ≥50% improvement from baseline in mean pain response (from the daily pain diary).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain</measure>
    <time_frame>Baseline, Week 2, and Week 4</time_frame>
    <description>Participants rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain</measure>
    <time_frame>Baseline, Week 2 and Week 4</time_frame>
    <description>Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain</measure>
    <time_frame>Baseline, Week 2, and Week 4</time_frame>
    <description>Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain</measure>
    <time_frame>Baseline, Week 2 and Week 4</time_frame>
    <description>Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia</measure>
    <time_frame>Baseline, Week 2 and Week 4</time_frame>
    <description>Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropathic Pain Symptom Inventory (NPSI) - Total Score</measure>
    <time_frame>Baseline, Week 2 and Week 4</time_frame>
    <description>Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's Global Impression of Change Score (PGIC).</measure>
    <time_frame>Baseline, Week 2, and Week 4</time_frame>
    <description>Participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse) at week 4. The PGIC was combined to produce a 3-point scale, &quot;Improved&quot;, &quot;No Change&quot; and &quot;Worse&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily Sleep Interference Scale Score (DSIS).</measure>
    <time_frame>Baseline, Week 1, Week 2, Week 3 and Week 4</time_frame>
    <description>Participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. This score was measured as a weekly average.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Amount of Rescue Medication Per Week</measure>
    <time_frame>Baseline, Week 1, Week 2, Week 3, and Week 4</time_frame>
    <description>Total amount of rescue medication participants take per week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days Participants Take Rescue Medication</measure>
    <time_frame>Baseline, Week 1, Week 2, Week 3 and Week 4</time_frame>
    <description>Number of days participants take rescue medication per week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs)</measure>
    <time_frame>Screening to Day 36, and Day 64</time_frame>
    <description>An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Laboratory Test Values of Potential Clinical Importance</measure>
    <time_frame>Screening, Day 1, Day 15 and Day 29</time_frame>
    <description>The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis and some other tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasted Total Cholesterol Values</measure>
    <time_frame>Baseline, Week 2 and Week 4</time_frame>
    <description>Percentage Change from Baseline in Fasted Total Cholesterol values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasted Low Density Lipoprotein (LDL) Cholesterol</measure>
    <time_frame>Baseline, Week 2 and Week 4</time_frame>
    <description>Percentage Change from Baseline in LDL cholesterol Friedewald by PEG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentration of PF-05089771</measure>
    <time_frame>Baseline, Week 2 and Week 4</time_frame>
    <description>All participants in this group were analysed. Only plasma PK concentration of PF-05089771 was analysed.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">141</enrollment>
  <condition>Diabetic Neuropathy, Painful</condition>
  <arm_group>
    <arm_group_label>PF-05089771</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Pregabalin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-05089771 + Pregabalin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-05089771 150 mg</intervention_name>
    <description>PF-05089771 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.</description>
    <arm_group_label>PF-05089771</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Matched placebo for PF-05089771 150 mg and pregabalin 300 mg</intervention_name>
    <description>Matched placebo for PF-05089771 150 mg twice daily and pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pregabalin 300 mg</intervention_name>
    <description>Pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.</description>
    <arm_group_label>Pregabalin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-05089771 150 mg + Pregabalin 300 mg</intervention_name>
    <description>PF-05089771 150 mg twice daily oral capsules with pregabalin 150 mg twice daily oral capsules. Treatment period = 4 weeks.</description>
    <arm_group_label>PF-05089771 + Pregabalin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women aged 18 years to 80 years.&#xD;
&#xD;
          -  Diagnosis of Type 2 diabetes mellitlus (T2DM) with current glycosylated hemoglobin A1c&#xD;
             (HbA1c) levels of ≤ 11% at Screening and on a stable antidiabetic medication regimen&#xD;
             for at least 30 days prior to randomization.&#xD;
&#xD;
          -  Presence of ongoing pain due to DPN for at least 6 months.&#xD;
&#xD;
          -  Willing to discontinue protocol-specified prohibited pain medications for DPN&#xD;
             throughout the duration of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Painful neuropathies or painful conditions other than DPN that may confound evaluation&#xD;
             of pain due to DPN during the study.&#xD;
&#xD;
          -  Subjects who have failed previously on pregabalin (at the recommended label dose and&#xD;
             for adequate duration) due to lack of efficacy.&#xD;
&#xD;
          -  Subjects with any clinically significant medical or psychiatric conditions or&#xD;
             clinically significant laboratory test abnormalities.&#xD;
&#xD;
          -  Pregnant women, lactating mothers, men with partners currently pregnant, women&#xD;
             suspected of being pregnant, and women who wish to be pregnant during the course of&#xD;
             the clinical study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Research Consortium Arizona</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Research Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neuro-Pain Medical Center</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridien Research</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PAB Clinical Research</name>
      <address>
        <city>Brandon</city>
        <state>Florida</state>
        <zip>33511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmonary Associates of Brandon (PAB)</name>
      <address>
        <city>Brandon</city>
        <state>Florida</state>
        <zip>33511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridien Research</name>
      <address>
        <city>Brooksville</city>
        <state>Florida</state>
        <zip>34601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Physiology Associates</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Clinical</name>
      <address>
        <city>Hallandale</city>
        <state>Florida</state>
        <zip>33009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridien Research</name>
      <address>
        <city>Lakeland</city>
        <state>Florida</state>
        <zip>33805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family Care Specialists</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34471</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renstar Medical Research</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34471</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oviedo Medical Research, LLC</name>
      <address>
        <city>Oviedo</city>
        <state>Florida</state>
        <zip>32765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridien Research</name>
      <address>
        <city>St. Petersburg</city>
        <state>Florida</state>
        <zip>33709</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridien Research</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33634</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metabolic Research Institute, Inc</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbus Regional Research Institute</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Advantage, Inc</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novex Clinical Research, LLC</name>
      <address>
        <city>New Bedford</city>
        <state>Massachusetts</state>
        <zip>02740</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beacon Clinical Research, LLC</name>
      <address>
        <city>Quincy</city>
        <state>Massachusetts</state>
        <zip>02169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan Head Pain and Neurological Institute</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Consortium</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Medical Research Network, LLC</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Phase Research and Development</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37919</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Internal Medicine Associates</name>
      <address>
        <city>Tullahoma</city>
        <state>Tennessee</state>
        <zip>37388</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trinity Clinical Research, LLC</name>
      <address>
        <city>Tullahoma</city>
        <state>Tennessee</state>
        <zip>37388</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KRK Medical Research</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nerve and Muscle Center of Texas</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Clinical Research - Norfolk, Inc</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Virginia Medical School</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rainier Clinical Research Center, Inc</name>
      <address>
        <city>Renton</city>
        <state>Washington</state>
        <zip>98057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3291026&amp;StudyName=A%20Clinical%20Trial%20To%20Evaluate%20PF-05089771%20On%20Its%20Own%20And%20As%20An%20Add-On%20Therapy%20To%20Pregabalin%20%28Lyrica%29%20For%20The%20Treatment%20Of%20Pain%20</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <results_first_submitted>July 12, 2016</results_first_submitted>
  <results_first_submitted_qc>March 26, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 5, 2017</results_first_posted>
  <last_update_submitted>March 26, 2017</last_update_submitted>
  <last_update_submitted_qc>March 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
    <mesh_term>Diabetic Neuropathies</mesh_term>
    <mesh_term>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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Information relating to our policy on data sharing and the process for requesting data can be found at the following link:&#xD;
http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Eligibility included healthy male and/or female participants of non childbearing potential between the ages of 18 and 80 years, inclusive, and a diagnosis of painful diabetic peripheral neuropathy and type II diabetes.&#xD;
Following the interim analysis, the study was stopped. No participants were dosed with PF-05089771 150mg BID + pregabalin.</recruitment_details>
      <pre_assignment_details>A number of 141 participants were the anticipated to be enrolled based on a discontinuation rate calculated from previous Pfizer DPN studies.&#xD;
The study discontinuation rate was lower than anticipated, hence fewer participants were randomized.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>PF-05089771 150 mg BID</title>
          <description>Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Pregabalin</title>
          <description>Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Participants received matched placebo oral capsule for 4 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="46"/>
                <participants group_id="P3" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="38"/>
                <participants group_id="P3" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Does not Meet Entrance Criteria</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </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="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The safety analysis set consisted of all participants who received at least one dose of study medication.</population>
      <group_list>
        <group group_id="B1">
          <title>PF-05089771 150 mg BID</title>
          <description>Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Pregabalin</title>
          <description>Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Participants received matched placebo oral capsule for 4 weeks.</description>
        </group>
        <group group_id="B4">
          <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="44"/>
            <count group_id="B2" value="46"/>
            <count group_id="B3" value="45"/>
            <count group_id="B4" value="135"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.3" spread="9.4"/>
                    <measurement group_id="B2" value="58.1" spread="11.3"/>
                    <measurement group_id="B3" value="59.2" spread="10.9"/>
                    <measurement group_id="B4" value="58.9" spread="10.5"/>
                  </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="17"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Daily Pain Numeric Rating Scale (NRS)</title>
        <description>The endpoint average pain score, based on the mean of the last 7 days' daily pain numeric rating scale (NRS) scores at (NRS is an 11-point scale where 0 = no pain and 10 = worst possible pain) from the daily pain diaries while receiving study medication during the treatment period.</description>
        <time_frame>Baseline, Week 1, Week 2, Week 3 and Week 4</time_frame>
        <population>The full analysis set included all randomized participants who received at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05089771 150 mg BID</title>
            <description>Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin</title>
            <description>Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matched placebo oral capsule for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Daily Pain Numeric Rating Scale (NRS)</title>
          <description>The endpoint average pain score, based on the mean of the last 7 days' daily pain numeric rating scale (NRS) scores at (NRS is an 11-point scale where 0 = no pain and 10 = worst possible pain) from the daily pain diaries while receiving study medication during the treatment period.</description>
          <population>The full analysis set included all randomized participants who received at least one dose of study medication.</population>
          <units>Unit on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n = 44, 46, 45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.17" spread="1.164"/>
                    <measurement group_id="O2" value="6.62" spread="1.420"/>
                    <measurement group_id="O3" value="6.35" spread="1.170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1 (n = 44, 46, 44)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.45" spread="1.372"/>
                    <measurement group_id="O2" value="5.87" spread="1.872"/>
                    <measurement group_id="O3" value="6.07" spread="1.454"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n = 43, 44, 40)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.14" spread="1.762"/>
                    <measurement group_id="O2" value="5.26" spread="2.302"/>
                    <measurement group_id="O3" value="6.10" spread="1.504"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 (n = 38, 40, 41)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.01" spread="1.820"/>
                    <measurement group_id="O2" value="5.36" spread="2.386"/>
                    <measurement group_id="O3" value="5.76" spread="1.540"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n = 41, 38, 39)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.83" spread="1.595"/>
                    <measurement group_id="O2" value="5.14" spread="2.508"/>
                    <measurement group_id="O3" value="5.61" spread="1.820"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for week 4. Mixed Models Repeated Measures analysis including all data up to Week 4 ,incorporating Bayesian priors separately on the placebo response and pregabalin effect.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.41</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.355</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.00</ci_lower_limit>
            <ci_upper_limit>0.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for week 4. Mixed Models Repeated Measures analysis including all data up to Week 4 ,incorporating Bayesian priors separately on the placebo response and pregabalin effect.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.53</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.230</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.91</ci_lower_limit>
            <ci_upper_limit>-0.20</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score</title>
        <description>Percentage of participants that received ≥30% improvement from baseline in mean pain response (from the daily pain diary).</description>
        <time_frame>Baseline, Week 1, Week 2, Week 3 and Week 4</time_frame>
        <population>The full analysis set included all randomized participants who received at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05089771 150 mg BID</title>
            <description>Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin</title>
            <description>Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matched placebo oral capsule for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score</title>
          <description>Percentage of participants that received ≥30% improvement from baseline in mean pain response (from the daily pain diary).</description>
          <population>The full analysis set included all randomized participants who received at least one dose of study medication.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 (n = 44, 46, 45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.09"/>
                    <measurement group_id="O2" value="15.22"/>
                    <measurement group_id="O3" value="4.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n = 44, 45, 44)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.73"/>
                    <measurement group_id="O2" value="31.11"/>
                    <measurement group_id="O3" value="9.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 (n = 42, 42, 43)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.81"/>
                    <measurement group_id="O2" value="26.19"/>
                    <measurement group_id="O3" value="11.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n = 42, 38, 43)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.57"/>
                    <measurement group_id="O2" value="31.58"/>
                    <measurement group_id="O3" value="16.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.91</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.78</ci_lower_limit>
            <ci_upper_limit>4.69</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.63</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.06</ci_lower_limit>
            <ci_upper_limit>6.56</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score</title>
        <description>Percentage of participants that received ≥50% improvement from baseline in mean pain response (from the daily pain diary).</description>
        <time_frame>Baseline, Week 1, Week 2, Week 3, and Week 4</time_frame>
        <population>The full analysis set included all randomized participants who received at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05089771 150 mg BID</title>
            <description>Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin</title>
            <description>Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matched placebo oral capsule for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score</title>
          <description>Percentage of participants that received ≥50% improvement from baseline in mean pain response (from the daily pain diary).</description>
          <population>The full analysis set included all randomized participants who received at least one dose of study medication.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 (n = 44, 46, 45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4.35"/>
                    <measurement group_id="O3" value="4.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n = 44, 45, 44)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.36"/>
                    <measurement group_id="O2" value="15.56"/>
                    <measurement group_id="O3" value="2.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 (n = 42, 42, 43)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.14"/>
                    <measurement group_id="O2" value="19.05"/>
                    <measurement group_id="O3" value="2.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n = 42, 38, 43)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.52"/>
                    <measurement group_id="O2" value="23.68"/>
                    <measurement group_id="O3" value="6.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.25</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.33</ci_lower_limit>
            <ci_upper_limit>4.74</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>4.75</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.43</ci_lower_limit>
            <ci_upper_limit>15.81</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain</title>
        <description>Participants rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.</description>
        <time_frame>Baseline, Week 2, and Week 4</time_frame>
        <population>The full analysis set included all randomized participants who received at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05089771 150 mg BID</title>
            <description>Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin</title>
            <description>Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matched placebo oral capsule for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain</title>
          <description>Participants rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.</description>
          <population>The full analysis set included all randomized participants who received at least one dose of study medication.</population>
          <units>Unit on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n = 44, 46, 45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" spread="2.71"/>
                    <measurement group_id="O2" value="5.3" spread="2.49"/>
                    <measurement group_id="O3" value="4.8" spread="2.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n = 42, 41, 43)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread="2.94"/>
                    <measurement group_id="O2" value="4.3" spread="3.06"/>
                    <measurement group_id="O3" value="4.2" spread="2.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n = 42, 38, 42)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="3.04"/>
                    <measurement group_id="O2" value="4.3" spread="2.80"/>
                    <measurement group_id="O3" value="4.5" spread="2.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.43</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.75</ci_lower_limit>
            <ci_upper_limit>-0.32</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.69</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.44</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.43</ci_lower_limit>
            <ci_upper_limit>0.04</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain</title>
        <description>Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.</description>
        <time_frame>Baseline, Week 2 and Week 4</time_frame>
        <population>The full analysis set included all randomized participants who received at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05089771 150 mg BID</title>
            <description>Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin</title>
            <description>Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matched placebo oral capsule for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain</title>
          <description>Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.</description>
          <population>The full analysis set included all randomized participants who received at least one dose of study medication.</population>
          <units>Unit on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n = 44, 46, 45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="2.48"/>
                    <measurement group_id="O2" value="4.9" spread="2.21"/>
                    <measurement group_id="O3" value="4.5" spread="2.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n = 42, 41, 43)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="2.51"/>
                    <measurement group_id="O2" value="4.4" spread="2.83"/>
                    <measurement group_id="O3" value="4.2" spread="2.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n = 42, 38, 42)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="2.67"/>
                    <measurement group_id="O2" value="3.9" spread="3.08"/>
                    <measurement group_id="O3" value="4.0" spread="2.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.22</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.39</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.86</ci_lower_limit>
            <ci_upper_limit>0.43</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.66</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.40</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.33</ci_lower_limit>
            <ci_upper_limit>0.00</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain</title>
        <description>Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.</description>
        <time_frame>Baseline, Week 2, and Week 4</time_frame>
        <population>The full analysis set included all randomized participants who received at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05089771 150 mg BID</title>
            <description>Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin</title>
            <description>Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matched placebo oral capsule for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain</title>
          <description>Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.</description>
          <population>The full analysis set included all randomized participants who received at least one dose of study medication.</population>
          <units>Unit on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n = 44, 46, 45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="2.36"/>
                    <measurement group_id="O2" value="5.8" spread="2.18"/>
                    <measurement group_id="O3" value="5.6" spread="2.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n = 42, 41, 43)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" spread="2.61"/>
                    <measurement group_id="O2" value="4.7" spread="2.98"/>
                    <measurement group_id="O3" value="4.9" spread="2.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n = 42, 38, 42）</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="2.87"/>
                    <measurement group_id="O2" value="4.6" spread="2.83"/>
                    <measurement group_id="O3" value="4.8" spread="2.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.10</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.46</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.87</ci_lower_limit>
            <ci_upper_limit>0.67</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.58</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.47</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.36</ci_lower_limit>
            <ci_upper_limit>0.20</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain</title>
        <description>Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.</description>
        <time_frame>Baseline, Week 2 and Week 4</time_frame>
        <population>The full analysis set included all randomized participants who received at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05089771 150 mg BID</title>
            <description>Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin</title>
            <description>Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matched placebo oral capsule for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain</title>
          <description>Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.</description>
          <population>The full analysis set included all randomized participants who received at least one dose of study medication.</population>
          <units>Unit on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n = 44, 45, 45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="2.38"/>
                    <measurement group_id="O2" value="5.0" spread="2.51"/>
                    <measurement group_id="O3" value="4.2" spread="2.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n = 42, 40, 43)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="1.92"/>
                    <measurement group_id="O2" value="4.0" spread="2.67"/>
                    <measurement group_id="O3" value="3.5" spread="2.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n = 42, 37, 42)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="2.24"/>
                    <measurement group_id="O2" value="3.8" spread="3.07"/>
                    <measurement group_id="O3" value="3.6" spread="2.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.09</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.35</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.49</ci_lower_limit>
            <ci_upper_limit>0.67</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.46</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.36</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.05</ci_lower_limit>
            <ci_upper_limit>0.13</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia</title>
        <description>Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.</description>
        <time_frame>Baseline, Week 2 and Week 4</time_frame>
        <population>The full analysis set included all randomized participants who received at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05089771 150 mg BID</title>
            <description>Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin</title>
            <description>Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matched placebo oral capsule for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia</title>
          <description>Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.</description>
          <population>The full analysis set included all randomized participants who received at least one dose of study medication.</population>
          <units>Unit on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n = 44, 46, 45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" spread="2.02"/>
                    <measurement group_id="O2" value="6.1" spread="2.35"/>
                    <measurement group_id="O3" value="6.6" spread="1.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n = 42, 41, 43)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="2.45"/>
                    <measurement group_id="O2" value="5.3" spread="2.83"/>
                    <measurement group_id="O3" value="5.9" spread="2.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n = 42, 38, 42)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="2.34"/>
                    <measurement group_id="O2" value="5.4" spread="2.84"/>
                    <measurement group_id="O3" value="5.9" spread="2.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.35</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.45</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.09</ci_lower_limit>
            <ci_upper_limit>0.39</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.24</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.45</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.00</ci_lower_limit>
            <ci_upper_limit>0.51</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Neuropathic Pain Symptom Inventory (NPSI) - Total Score</title>
        <description>Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.</description>
        <time_frame>Baseline, Week 2 and Week 4</time_frame>
        <population>The full analysis set included all randomized participants who received at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05089771 150 mg BID</title>
            <description>Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin</title>
            <description>Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matched placebo oral capsule for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Neuropathic Pain Symptom Inventory (NPSI) - Total Score</title>
          <description>Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.</description>
          <population>The full analysis set included all randomized participants who received at least one dose of study medication.</population>
          <units>Unit on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n = 44, 45, 45）</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.6" spread="17.33"/>
                    <measurement group_id="O2" value="53.4" spread="19.35"/>
                    <measurement group_id="O3" value="50.7" spread="16.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n = 42, 40, 34)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.2" spread="17.39"/>
                    <measurement group_id="O2" value="44.6" spread="24.64"/>
                    <measurement group_id="O3" value="44.7" spread="18.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n = 42, 37, 42)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.7" spread="19.40"/>
                    <measurement group_id="O2" value="42.7" spread="27.23"/>
                    <measurement group_id="O3" value="44.5" spread="20.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.27</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.92</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.12</ci_lower_limit>
            <ci_upper_limit>4.57</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-5.61</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.99</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.57</ci_lower_limit>
            <ci_upper_limit>-0.66</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient's Global Impression of Change Score (PGIC).</title>
        <description>Participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse) at week 4. The PGIC was combined to produce a 3-point scale, &quot;Improved&quot;, &quot;No Change&quot; and &quot;Worse&quot;.</description>
        <time_frame>Baseline, Week 2, and Week 4</time_frame>
        <population>The full analysis set included all randomized participants who received at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05089771 150 mg BID</title>
            <description>Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin</title>
            <description>Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matched placebo oral capsule for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient's Global Impression of Change Score (PGIC).</title>
          <description>Participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse) at week 4. The PGIC was combined to produce a 3-point scale, &quot;Improved&quot;, &quot;No Change&quot; and &quot;Worse&quot;.</description>
          <population>The full analysis set included all randomized participants who received at least one dose of study medication.</population>
          <units>Number of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improved (Baseline, n = 43, 46, 45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Improved (Week 2, n = 42, 41, 43)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Improved (Week 4, n = 42, 38, 42)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No change (Baseline, n = 43, 46, 45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No change (Week 2, n = 42, 41, 43)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No change (Week 4, n = 42, 38, 42)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Worse (Baseline, n = 43, 46, 35)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Worse (Week 2, n = 42, 41, 43)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Worse (Week 4, n = 42, 38, 42)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for Week 4. Proportional Odds Logistic Regression including all data up to week 4.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.70</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.34</ci_lower_limit>
            <ci_upper_limit>1.45</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for Week 4. Proportional Odds Logistic Regression including all data up to week 4.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.50</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.24</ci_lower_limit>
            <ci_upper_limit>1.07</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Daily Sleep Interference Scale Score (DSIS).</title>
        <description>Participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. This score was measured as a weekly average.</description>
        <time_frame>Baseline, Week 1, Week 2, Week 3 and Week 4</time_frame>
        <population>The full analysis set included all randomized participants who received at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05089771 150 mg BID</title>
            <description>Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin</title>
            <description>Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matched placebo oral capsule for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Daily Sleep Interference Scale Score (DSIS).</title>
          <description>Participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. This score was measured as a weekly average.</description>
          <population>The full analysis set included all randomized participants who received at least one dose of study medication.</population>
          <units>number on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n = 44, 46, 45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" spread="2.42"/>
                    <measurement group_id="O2" value="5.6" spread="2.38"/>
                    <measurement group_id="O3" value="4.9" spread="2.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1 (n= 44, 46, 44)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" spread="2.29"/>
                    <measurement group_id="O2" value="4.7" spread="2.55"/>
                    <measurement group_id="O3" value="4.7" spread="2.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n = 43, 44, 40)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="2.33"/>
                    <measurement group_id="O2" value="4.1" spread="2.74"/>
                    <measurement group_id="O3" value="4.7" spread="2.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 (n = 38, 40, 41)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="2.28"/>
                    <measurement group_id="O2" value="4.4" spread="2.71"/>
                    <measurement group_id="O3" value="4.3" spread="2.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n = 41, 38, 39)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="2.13"/>
                    <measurement group_id="O2" value="4.2" spread="2.82"/>
                    <measurement group_id="O3" value="4.3" spread="2.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.59</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.34</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.16</ci_lower_limit>
            <ci_upper_limit>-0.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.00</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.34</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.57</ci_lower_limit>
            <ci_upper_limit>-0.43</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Amount of Rescue Medication Per Week</title>
        <description>Total amount of rescue medication participants take per week</description>
        <time_frame>Baseline, Week 1, Week 2, Week 3, and Week 4</time_frame>
        <population>The full analysis set included all randomized participants who received at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05089771 150 mg BID</title>
            <description>Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin</title>
            <description>Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matched placebo oral capsule for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Amount of Rescue Medication Per Week</title>
          <description>Total amount of rescue medication participants take per week</description>
          <population>The full analysis set included all randomized participants who received at least one dose of study medication.</population>
          <units>mg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n = 44, 46, 45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2726" spread="4310"/>
                    <measurement group_id="O2" value="3398" spread="5723"/>
                    <measurement group_id="O3" value="1863" spread="3684"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1 (n = 44, 46, 45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2272" spread="4043"/>
                    <measurement group_id="O2" value="2897" spread="5605"/>
                    <measurement group_id="O3" value="1694" spread="3425"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n = 44, 45, 44)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1669" spread="3248"/>
                    <measurement group_id="O2" value="2952" spread="5488"/>
                    <measurement group_id="O3" value="1391" spread="3238"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 (n = 42, 42, 43)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1851" spread="3228"/>
                    <measurement group_id="O2" value="1885" spread="4918"/>
                    <measurement group_id="O3" value="1306" spread="3308"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n = 42, 38, 43)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1617" spread="2945"/>
                    <measurement group_id="O2" value="2328" spread="5256"/>
                    <measurement group_id="O3" value="1372" spread="3307"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>192</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>816</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1161</ci_lower_limit>
            <ci_upper_limit>1544</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>611</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>812</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-735</ci_lower_limit>
            <ci_upper_limit>1956</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days Participants Take Rescue Medication</title>
        <description>Number of days participants take rescue medication per week.</description>
        <time_frame>Baseline, Week 1, Week 2, Week 3 and Week 4</time_frame>
        <population>The full analysis set included all randomized participants who received at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05089771 150 mg BID</title>
            <description>Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin</title>
            <description>Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matched placebo oral capsule for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days Participants Take Rescue Medication</title>
          <description>Number of days participants take rescue medication per week.</description>
          <population>The full analysis set included all randomized participants who received at least one dose of study medication.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n = 44, 46, 45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="3.49"/>
                    <measurement group_id="O2" value="2.1" spread="3.02"/>
                    <measurement group_id="O3" value="1.6" spread="2.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1 (n = 44, 46, 45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="3.16"/>
                    <measurement group_id="O2" value="1.8" spread="2.74"/>
                    <measurement group_id="O3" value="1.5" spread="2.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n = 44, 45, 44)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="3.08"/>
                    <measurement group_id="O2" value="1.7" spread="2.63"/>
                    <measurement group_id="O3" value="1.2" spread="2.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 (n = 42, 42, 43)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="3.00"/>
                    <measurement group_id="O2" value="1.2" spread="2.35"/>
                    <measurement group_id="O3" value="1.0" spread="2.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n = 42, 38, 43)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="2.80"/>
                    <measurement group_id="O2" value="1.6" spread="2.55"/>
                    <measurement group_id="O3" value="1.1" spread="2.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs)</title>
        <description>An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect.</description>
        <time_frame>Screening to Day 36, and Day 64</time_frame>
        <population>The safety analysis set included all participants who receive at least 1 dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05089771 150 mg BID</title>
            <description>Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin</title>
            <description>Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matched placebo oral capsule for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs)</title>
          <description>An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect.</description>
          <population>The safety analysis set included all participants who receive at least 1 dose of study medication.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Withdrawals due to AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Laboratory Test Values of Potential Clinical Importance</title>
        <description>The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis and some other tests.</description>
        <time_frame>Screening, Day 1, Day 15 and Day 29</time_frame>
        <population>The safety analysis set included all participants who receive at least 1 dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05089771 150 mg BID</title>
            <description>Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin</title>
            <description>Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matched placebo oral capsule for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Laboratory Test Values of Potential Clinical Importance</title>
          <description>The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis and some other tests.</description>
          <population>The safety analysis set included all participants who receive at least 1 dose of study medication.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="35"/>
                    <measurement group_id="O3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fasted Total Cholesterol Values</title>
        <description>Percentage Change from Baseline in Fasted Total Cholesterol values</description>
        <time_frame>Baseline, Week 2 and Week 4</time_frame>
        <population>The safety analysis set included all participants who receive at least 1 dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05089771 150 mg BID</title>
            <description>Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin</title>
            <description>Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matched placebo oral capsule for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Fasted Total Cholesterol Values</title>
          <description>Percentage Change from Baseline in Fasted Total Cholesterol values</description>
          <population>The safety analysis set included all participants who receive at least 1 dose of study medication.</population>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2 (n = 41, 37, 41)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.46" spread="12.279"/>
                    <measurement group_id="O2" value="-1.45" spread="10.242"/>
                    <measurement group_id="O3" value="-0.43" spread="14.271"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n = 40, 33, 39)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.59" spread="15.618"/>
                    <measurement group_id="O2" value="-0.11" spread="10.023"/>
                    <measurement group_id="O3" value="-1.71" spread="14.242"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>7.99</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.03</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.98</ci_lower_limit>
            <ci_upper_limit>13.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.75</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.14</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.46</ci_lower_limit>
            <ci_upper_limit>5.95</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fasted Low Density Lipoprotein (LDL) Cholesterol</title>
        <description>Percentage Change from Baseline in LDL cholesterol Friedewald by PEG</description>
        <time_frame>Baseline, Week 2 and Week 4</time_frame>
        <population>The safety analysis set included all participants who receive at least 1 dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05089771 150 mg BID</title>
            <description>Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin</title>
            <description>Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matched placebo oral capsule for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Fasted Low Density Lipoprotein (LDL) Cholesterol</title>
          <description>Percentage Change from Baseline in LDL cholesterol Friedewald by PEG</description>
          <population>The safety analysis set included all participants who receive at least 1 dose of study medication.</population>
          <units>Perecent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2 (n = 38, 34, 39)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.17" spread="23.849"/>
                    <measurement group_id="O2" value="-1.73" spread="14.496"/>
                    <measurement group_id="O3" value="0.81" spread="22.900"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n = 37, 31, 36)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.61" spread="29.729"/>
                    <measurement group_id="O2" value="0.85" spread="13.512"/>
                    <measurement group_id="O3" value="1.48" spread="19.804"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>11.55</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.19</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.94</ci_lower_limit>
            <ci_upper_limit>20.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.42</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.40</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.38</ci_lower_limit>
            <ci_upper_limit>6.54</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Concentration of PF-05089771</title>
        <description>All participants in this group were analysed. Only plasma PK concentration of PF-05089771 was analysed.</description>
        <time_frame>Baseline, Week 2 and Week 4</time_frame>
        <population>The PK concentration analysis set included all randomized participants who received at least one dose of study medication and who had at least 1 measurable concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05089771 150 mg BID</title>
            <description>Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of PF-05089771</title>
          <description>All participants in this group were analysed. Only plasma PK concentration of PF-05089771 was analysed.</description>
          <population>The PK concentration analysis set included all randomized participants who received at least one dose of study medication and who had at least 1 measurable concentration.</population>
          <units>ng/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n = 43)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">No Mean/SD at baseline. No subject had PK concentration value above lower limit of quantification at baseline in both groups. Summary statistics are not presented.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n = 41)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7673" spread="4861"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n = 41)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8784" spread="5749"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of placebo run-in until 28 days after last dose of placebo run-out, an average of 3 months.</time_frame>
      <desc>The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.</desc>
      <group_list>
        <group group_id="E1">
          <title>PF-05089771 150 mg BID</title>
          <description>Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Pregabalin</title>
          <description>Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Participants received matched placebo oral capsule for 4 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 18.1</default_vocab>
        <default_assessment>Non-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="3" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="46"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="46"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Vulvovaginal pruritus</sub_title>
                <description>AE specific to female participants. Hence the number of participants at risk refers to number of female participants.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
              </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>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer, Inc</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.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/NCT02215252
org study id: B3291026
secondary id: DPN NAV1.7
nct id: NCT02215252
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the efficacy and safety of PF-05089771 as a
      monotherapy and as an add-on to pregabalin for the treatment of painful diabetic peripheral
      neuropathy (DPN)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Daily Pain Numeric Rating Scale (NRS)
time frame: Baseline, Week 1, Week 2, Week 3 and Week 4
description: The endpoint average pain score, based on the mean of the last 7 days' daily pain numeric rating scale (NRS) scores at (NRS is an 11-point scale where 0 = no pain and 10 = worst possible pain) from the daily pain diaries while receiving study medication during the treatment period.
measure: Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score
time frame: Baseline, Week 1, Week 2, Week 3 and Week 4
description: Percentage of participants that received ≥30% improvement from baseline in mean pain response (from the daily pain diary).
measure: Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score
time frame: Baseline, Week 1, Week 2, Week 3, and Week 4
description: Percentage of participants that received ≥50% improvement from baseline in mean pain response (from the daily pain diary).
measure: Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain
time frame: Baseline, Week 2, and Week 4
description: Participants rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
measure: Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain
time frame: Baseline, Week 2 and Week 4
description: Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
measure: Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain
time frame: Baseline, Week 2, and Week 4
description: Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
measure: Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain
time frame: Baseline, Week 2 and Week 4
description: Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
measure: Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia
time frame: Baseline, Week 2 and Week 4
description: Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
measure: Neuropathic Pain Symptom Inventory (NPSI) - Total Score
time frame: Baseline, Week 2 and Week 4
description: Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
measure: Patient's Global Impression of Change Score (PGIC).
time frame: Baseline, Week 2, and Week 4
description: Participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse) at week 4. The PGIC was combined to produce a 3-point scale, "Improved", "No Change" and "Worse".
measure: Daily Sleep Interference Scale Score (DSIS).
time frame: Baseline, Week 1, Week 2, Week 3 and Week 4
description: Participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. This score was measured as a weekly average.
measure: Total Amount of Rescue Medication Per Week
time frame: Baseline, Week 1, Week 2, Week 3, and Week 4
description: Total amount of rescue medication participants take per week
measure: Number of Days Participants Take Rescue Medication
time frame: Baseline, Week 1, Week 2, Week 3 and Week 4
description: Number of days participants take rescue medication per week.
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs)
time frame: Screening to Day 36, and Day 64
description: An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect.
measure: Number of Participants With Laboratory Test Values of Potential Clinical Importance
time frame: Screening, Day 1, Day 15 and Day 29
description: The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis and some other tests.
measure: Fasted Total Cholesterol Values
time frame: Baseline, Week 2 and Week 4
description: Percentage Change from Baseline in Fasted Total Cholesterol values
measure: Fasted Low Density Lipoprotein (LDL) Cholesterol
time frame: Baseline, Week 2 and Week 4
description: Percentage Change from Baseline in LDL cholesterol Friedewald by PEG
measure: Plasma Concentration of PF-05089771
time frame: Baseline, Week 2 and Week 4
description: All participants in this group were analysed. Only plasma PK concentration of PF-05089771 was analysed.
arm group label: PF-05089771
arm group type: Experimental
arm group label: Placebo
arm group type: Experimental
arm group label: Pregabalin
arm group type: Experimental
arm group label: PF-05089771 + Pregabalin
arm group type: Experimental
intervention type: Drug
intervention name: PF-05089771 150 mg
description: PF-05089771 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
arm group label: PF-05089771
intervention type: Drug
intervention name: Matched placebo for PF-05089771 150 mg and pregabalin 300 mg
description: Matched placebo for PF-05089771 150 mg twice daily and pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
arm group label: Placebo
intervention type: Drug
intervention name: Pregabalin 300 mg
description: Pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
arm group label: Pregabalin
intervention type: Drug
intervention name: PF-05089771 150 mg + Pregabalin 300 mg
description: PF-05089771 150 mg twice daily oral capsules with pregabalin 150 mg twice daily oral capsules. Treatment period = 4 weeks.
arm group label: PF-05089771 + Pregabalin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: United States
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3291026&StudyName=A%20Clinical%20Trial%20To%20Evaluate%20PF-05089771%20On%20Its%20Own%20And%20As%20An%20Add-On%20Therapy%20To%20Pregabalin%20%28Lyrica%29%20For%20The%20Treatment%20Of%20Pain%20
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Peripheral Nervous System Diseases
mesh term: Diabetic Neuropathies
mesh term: Pain
mesh term: Pregabalin
sharing ipd: Yes
ipd description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link:
http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 