<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/NCT03764072</url>
  </required_header>
  <id_info>
    <org_study_id>VX18-150-104</org_study_id>
    <nct_id>NCT03764072</nct_id>
  </id_info>
  <brief_title>A Dose-ranging Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy</brief_title>
  <official_title>A Phase 2B Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel-design Study of the Efficacy and Safety of VX-150 for Acute Pain Following Bunionectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vertex Pharmaceuticals Incorporated</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vertex Pharmaceuticals Incorporated</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the dose-response relationship and safety of VX-150 in treating&#xD;
      acute pain following bunionectomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2018</start_date>
  <completion_date type="Actual">January 25, 2019</completion_date>
  <primary_completion_date type="Actual">January 17, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <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>Time-weighted Sum of the Pain Intensity Difference as Recorded on Numeric Pain Rating Scale (NPRS) 0 to 24 Hours (SPID24) After First Dose</measure>
    <time_frame>0 to 24 Hours After First Dose</time_frame>
    <description>SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the pain intensity score at given post-dose time points from the baseline pain intensity scores (using pain rating score range: 0= no pain to 10= worst possible pain). SPID24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time-weighted Sum of Pain Intensity Difference as Recorded on NPRS 0 to 48 Hours (SPID48) After First Dose</measure>
    <time_frame>0 to 48 Hours After First Dose</time_frame>
    <description>SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the pain intensity score at given post-dose time points from the baseline pain intensity scores (using pain rating score range: 0= no pain to 10= worst possible pain). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With at Least 30 Percent (%) Reduction in NPRS at 24 Hours After First Dose of VX-150 Versus Placebo</measure>
    <time_frame>From Baseline at 24 Hours After First Dose</time_frame>
    <description>Pain intensity was recorded on 11-point ordinal NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The percentage of participants with at least 30% reduction from baseline in NPRS at 24 hours after the first dose of VX-150 or placebo were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With at Least 50% Reduction in NPRS at 24 Hours After the First Dose of VX-150 Versus Placebo</measure>
    <time_frame>From Baseline at 24 Hours After First Dose</time_frame>
    <description>Pain intensity was recorded on 11-point ordinal NPRS, score range: 0 to 10, where 0=no pain and 10=worst imaginable pain. The percentage of participants with at least 50% reduction from baseline in NPRS at 24 hours after the first dose of VX-150 or placebo were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With at Least 70% Reduction in NPRS at 24 Hours After the First Dose of VX-150 Versus Placebo</measure>
    <time_frame>From Baseline at 24 Hours After First Dose</time_frame>
    <description>Pain intensity was recorded on 11-point ordinal NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The percentage of participants with at least 70% reduction from baseline in NPRS at 24 hours after the first dose of VX-150 or placebo were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Onset of Confirmed Perceptible Pain Relief After First Dose of VX-150 Versus Placebo</measure>
    <time_frame>Up to 6 hours After the First Dose</time_frame>
    <description>Time to onset of confirmed perceptible pain relief (time to onset of perceptible pain relief [any pain relief at all after the first dose] for participants who had meaningful pain relief [relief that is meaningful to participants after the first dose] reported based on the stopwatch assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Onset of Meaningful Pain Relief After the First Dose of VX-150 Versus Placebo</measure>
    <time_frame>Up to 6 Hours After the First Dose</time_frame>
    <description>Time to onset of meaningful pain relief (relief that is meaningful to participants after the first dose) reported based on the stopwatch assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Concentration (Cmax) of VRT- 1207355 (Active Moiety) and VRT- 1268114 (Metabolite M5)</measure>
    <time_frame>Day 1 and Day 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VRT- 1207355 and VRT- 1268114</measure>
    <time_frame>Day 1 and Day 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Day 1 up to Day 10</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Acute Pain</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received placebo matched to VX-150 for 2 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VX-150 - Dose Level 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received VX-150 1500 milligrams (mg) as first dose, followed by VX-150 750 mg every 12 hours (q12h) for 2 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VX-150 - Dose Level 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received VX-150 1000 mg once daily (qd) for 2 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VX-150 - Dose Level 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received VX-150 500 mg q12h for 2 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VX-150 - Dose Level 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VX-150 - Dose Level 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received VX-150 250 mg qd for 2 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VX-150</intervention_name>
    <description>Capsules for oral administration.</description>
    <arm_group_label>VX-150 - Dose Level 1</arm_group_label>
    <arm_group_label>VX-150 - Dose Level 2</arm_group_label>
    <arm_group_label>VX-150 - Dose Level 3</arm_group_label>
    <arm_group_label>VX-150 - Dose Level 4</arm_group_label>
    <arm_group_label>VX-150 - Dose Level 5</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Capsules for oral administration.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
        Before surgery:&#xD;
&#xD;
          -  Body mass index (BMI) of 18.0 to 38.0 kilogram per meter square (kg/m^2)&#xD;
&#xD;
          -  Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair,&#xD;
             without collateral procedures, under regional anesthesia (Mayo and popliteal sciatic&#xD;
             block) not to include base wedge procedure&#xD;
&#xD;
        After surgery:&#xD;
&#xD;
          -  Subject reported pain of greater than or equal to (&gt;=) 4 on Numeric Pain Rating Scale&#xD;
             (NPRS) and moderate or severe pain on the Verbal Categorical Rating Scale (VRS) within&#xD;
             9 hours after removal of the popliteal sciatic block on Day 1&#xD;
&#xD;
          -  Subject is lucid and able to follow commands&#xD;
&#xD;
          -  All analgesic guidelines were followed during and after the bunionectomy&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
        Before surgery:&#xD;
&#xD;
          -  History in the past 10 years of malignancy, except for squamous cell skin cancer,&#xD;
             basal cell skin cancer, and Stage 0 cervical carcinoma in situ&#xD;
&#xD;
          -  History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)&#xD;
&#xD;
          -  History of abnormal laboratory results &gt;=2.5*upper limit of normal (ULN)&#xD;
&#xD;
          -  History of peripheral neuropathy&#xD;
&#xD;
          -  A known or clinically suspected infection with human immunodeficiency virus or&#xD;
             hepatitis B or C viruses&#xD;
&#xD;
          -  Prior medical history of bunionectomy or other foot surgery on the index foot&#xD;
&#xD;
          -  History of peptic ulcer disease, or intolerance or unwillingness to receive ibuprofen&#xD;
&#xD;
        After surgery:&#xD;
&#xD;
          -  Subject had a type 3 deformity requiring a base wedge osteotomy or concomitant surgery&#xD;
&#xD;
        Other protocol defined inclusion/exclusion criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Arizona Research Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85053</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anaheim Clinical Trials</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lotus Clinical Research</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chesapeake Research Group</name>
      <address>
        <city>Pasadena</city>
        <state>Maryland</state>
        <zip>21122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endeavor Clinical Trials</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JBR Clinical Research</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <results_first_submitted>January 13, 2022</results_first_submitted>
  <results_first_submitted_qc>January 13, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 9, 2022</results_first_posted>
  <disposition_first_submitted>January 17, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>January 17, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">January 27, 2020</disposition_first_posted>
  <last_update_submitted>January 13, 2022</last_update_submitted>
  <last_update_submitted_qc>January 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2022</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>Acute Pain</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 26, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT03764072/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 5, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT03764072/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received placebo matched to VX-150 for 2 days.</description>
        </group>
        <group group_id="P2">
          <title>VX-150 - Dose Level 1</title>
          <description>Participants received VX-150 1500 milligrams (mg) as first dose, followed by VX-150 750 mg every 12 hours (q12h) for 2 days.</description>
        </group>
        <group group_id="P3">
          <title>VX-150 - Dose Level 2</title>
          <description>Participants received VX-150 1000 mg once daily (qd) for 2 days.</description>
        </group>
        <group group_id="P4">
          <title>VX-150 - Dose Level 3</title>
          <description>Participants received VX-150 500 mg q12h for 2 days.</description>
        </group>
        <group group_id="P5">
          <title>VX-150 - Dose Level 4</title>
          <description>Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.</description>
        </group>
        <group group_id="P6">
          <title>VX-150 - Dose Level 5</title>
          <description>Participants received VX-150 250 mg qd for 2 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="42"/>
                <participants group_id="P3" count="44"/>
                <participants group_id="P4" count="45"/>
                <participants group_id="P5" count="46"/>
                <participants group_id="P6" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="42"/>
                <participants group_id="P3" count="43"/>
                <participants group_id="P4" count="45"/>
                <participants group_id="P5" count="45"/>
                <participants group_id="P6" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal of consent (due to lack of efficacy)</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal of consent (for other reason)</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
              </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="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received placebo matched to VX-150 for 2 days.</description>
        </group>
        <group group_id="B2">
          <title>VX-150 - Dose Level 1</title>
          <description>Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.</description>
        </group>
        <group group_id="B3">
          <title>VX-150 - Dose Level 2</title>
          <description>Participants received VX-150 1000 mg qd for 2 days.</description>
        </group>
        <group group_id="B4">
          <title>VX-150 - Dose Level 3</title>
          <description>Participants received VX-150 500 mg q12h for 2 days.</description>
        </group>
        <group group_id="B5">
          <title>VX-150 - Dose Level 4</title>
          <description>Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.</description>
        </group>
        <group group_id="B6">
          <title>VX-150 - Dose Level 5</title>
          <description>Participants received VX-150 250 mg qd for 2 days.</description>
        </group>
        <group group_id="B7">
          <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="46"/>
            <count group_id="B2" value="42"/>
            <count group_id="B3" value="44"/>
            <count group_id="B4" value="45"/>
            <count group_id="B5" value="46"/>
            <count group_id="B6" value="27"/>
            <count group_id="B7" value="250"/>
          </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="46.5" spread="14.21"/>
                    <measurement group_id="B2" value="44.6" spread="13.03"/>
                    <measurement group_id="B3" value="44.7" spread="13.23"/>
                    <measurement group_id="B4" value="46.4" spread="12.18"/>
                    <measurement group_id="B5" value="47.2" spread="11.51"/>
                    <measurement group_id="B6" value="48.7" spread="12.92"/>
                    <measurement group_id="B7" value="46.2" spread="12.81"/>
                  </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="40"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="40"/>
                    <measurement group_id="B4" value="39"/>
                    <measurement group_id="B5" value="40"/>
                    <measurement group_id="B6" value="21"/>
                    <measurement group_id="B7" value="217"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="16"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="82"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="29"/>
                    <measurement group_id="B4" value="32"/>
                    <measurement group_id="B5" value="30"/>
                    <measurement group_id="B6" value="19"/>
                    <measurement group_id="B7" value="168"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="31"/>
                    <measurement group_id="B5" value="34"/>
                    <measurement group_id="B6" value="23"/>
                    <measurement group_id="B7" value="188"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pain Intensity at Baseline (at 0 hours) as Recorded on Numeric Pain Rating Scale (NPRS)</title>
          <description>Pain intensity was recorded on 11-point ordinal NPRS, score range: 0 to 10, where 0=no pain and 10=worst imaginable pain.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.5" spread="1.8"/>
                    <measurement group_id="B2" value="7.0" spread="2.0"/>
                    <measurement group_id="B3" value="6.5" spread="1.8"/>
                    <measurement group_id="B4" value="6.6" spread="1.7"/>
                    <measurement group_id="B5" value="5.9" spread="1.3"/>
                    <measurement group_id="B6" value="6.9" spread="1.6"/>
                    <measurement group_id="B7" value="6.5" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time-weighted Sum of the Pain Intensity Difference as Recorded on Numeric Pain Rating Scale (NPRS) 0 to 24 Hours (SPID24) After First Dose</title>
        <description>SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the pain intensity score at given post-dose time points from the baseline pain intensity scores (using pain rating score range: 0= no pain to 10= worst possible pain). SPID24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score).</description>
        <time_frame>0 to 24 Hours After First Dose</time_frame>
        <population>Full analysis set (FAS) included all randomized participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to VX-150 for 2 days.</description>
          </group>
          <group group_id="O2">
            <title>VX-150 - Dose Level 1</title>
            <description>Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.</description>
          </group>
          <group group_id="O3">
            <title>VX-150 - Dose Level 2</title>
            <description>Participants received VX-150 1000 mg qd for 2 days.</description>
          </group>
          <group group_id="O4">
            <title>VX-150 - Dose Level 3</title>
            <description>Participants received VX-150 500 mg q12h for 2 days.</description>
          </group>
          <group group_id="O5">
            <title>VX-150 - Dose Level 4</title>
            <description>Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.</description>
          </group>
          <group group_id="O6">
            <title>VX-150 - Dose Level 5</title>
            <description>Participants received VX-150 250 mg qd for 2 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Time-weighted Sum of the Pain Intensity Difference as Recorded on Numeric Pain Rating Scale (NPRS) 0 to 24 Hours (SPID24) After First Dose</title>
          <description>SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the pain intensity score at given post-dose time points from the baseline pain intensity scores (using pain rating score range: 0= no pain to 10= worst possible pain). SPID24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score).</description>
          <population>Full analysis set (FAS) included all randomized participants who received at least 1 dose of study drug.</population>
          <units>units 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="46"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="45"/>
                <count group_id="O5" value="46"/>
                <count group_id="O6" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.1" spread="49.7"/>
                    <measurement group_id="O2" value="37.3" spread="45.6"/>
                    <measurement group_id="O3" value="32.3" spread="51.2"/>
                    <measurement group_id="O4" value="30.5" spread="46.9"/>
                    <measurement group_id="O5" value="27.5" spread="37.8"/>
                    <measurement group_id="O6" value="28.3" spread="43.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2107</p_value>
            <p_value_desc>Dose response Model - Linear</p_value_desc>
            <method>Multiple Comparison Procedure-Modelling</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0766</p_value>
            <p_value_desc>Dose response Model - Emax</p_value_desc>
            <method>Multiple Comparison Procedure-Modelling</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0989</p_value>
            <p_value_desc>Dose response Model - Logistic</p_value_desc>
            <method>Multiple Comparison Procedure-Modelling</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0927</p_value>
            <p_value_desc>Dose-response Model - Sigmoid Emax</p_value_desc>
            <method>Multiple Comparison Procedure-Modelling</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time-weighted Sum of Pain Intensity Difference as Recorded on NPRS 0 to 48 Hours (SPID48) After First Dose</title>
        <description>SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the pain intensity score at given post-dose time points from the baseline pain intensity scores (using pain rating score range: 0= no pain to 10= worst possible pain). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).</description>
        <time_frame>0 to 48 Hours After First Dose</time_frame>
        <population>FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to VX-150 for 2 days.</description>
          </group>
          <group group_id="O2">
            <title>VX-150 - Dose Level 1</title>
            <description>Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.</description>
          </group>
          <group group_id="O3">
            <title>VX-150 - Dose Level 2</title>
            <description>Participants received VX-150 1000 mg qd for 2 days.</description>
          </group>
          <group group_id="O4">
            <title>VX-150 - Dose Level 3</title>
            <description>Participants received VX-150 500 mg q12h for 2 days.</description>
          </group>
          <group group_id="O5">
            <title>VX-150 - Dose Level 4</title>
            <description>Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.</description>
          </group>
          <group group_id="O6">
            <title>VX-150 - Dose Level 5</title>
            <description>Participants received VX-150 250 mg qd for 2 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Time-weighted Sum of Pain Intensity Difference as Recorded on NPRS 0 to 48 Hours (SPID48) After First Dose</title>
          <description>SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the pain intensity score at given post-dose time points from the baseline pain intensity scores (using pain rating score range: 0= no pain to 10= worst possible pain). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).</description>
          <population>FAS.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="45"/>
                <count group_id="O5" value="46"/>
                <count group_id="O6" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.4" spread="105.2"/>
                    <measurement group_id="O2" value="112.5" spread="88.4"/>
                    <measurement group_id="O3" value="106.1" spread="109.6"/>
                    <measurement group_id="O4" value="101.5" spread="103.2"/>
                    <measurement group_id="O5" value="90.9" spread="81.9"/>
                    <measurement group_id="O6" value="100.0" spread="102.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With at Least 30 Percent (%) Reduction in NPRS at 24 Hours After First Dose of VX-150 Versus Placebo</title>
        <description>Pain intensity was recorded on 11-point ordinal NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The percentage of participants with at least 30% reduction from baseline in NPRS at 24 hours after the first dose of VX-150 or placebo were reported.</description>
        <time_frame>From Baseline at 24 Hours After First Dose</time_frame>
        <population>FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to VX-150 for 2 days.</description>
          </group>
          <group group_id="O2">
            <title>VX-150 - Dose Level 1</title>
            <description>Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.</description>
          </group>
          <group group_id="O3">
            <title>VX-150 - Dose Level 2</title>
            <description>Participants received VX-150 1000 mg qd for 2 days.</description>
          </group>
          <group group_id="O4">
            <title>VX-150 - Dose Level 3</title>
            <description>Participants received VX-150 500 mg q12h for 2 days.</description>
          </group>
          <group group_id="O5">
            <title>VX-150 - Dose Level 4</title>
            <description>Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.</description>
          </group>
          <group group_id="O6">
            <title>VX-150 - Dose Level 5</title>
            <description>Participants received VX-150 250 mg qd for 2 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With at Least 30 Percent (%) Reduction in NPRS at 24 Hours After First Dose of VX-150 Versus Placebo</title>
          <description>Pain intensity was recorded on 11-point ordinal NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The percentage of participants with at least 30% reduction from baseline in NPRS at 24 hours after the first dose of VX-150 or placebo were reported.</description>
          <population>FAS.</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="46"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="45"/>
                <count group_id="O5" value="46"/>
                <count group_id="O6" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="59.5"/>
                    <measurement group_id="O3" value="56.8"/>
                    <measurement group_id="O4" value="55.6"/>
                    <measurement group_id="O5" value="63.0"/>
                    <measurement group_id="O6" value="51.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3162</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4613</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4095</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1570</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9843</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With at Least 50% Reduction in NPRS at 24 Hours After the First Dose of VX-150 Versus Placebo</title>
        <description>Pain intensity was recorded on 11-point ordinal NPRS, score range: 0 to 10, where 0=no pain and 10=worst imaginable pain. The percentage of participants with at least 50% reduction from baseline in NPRS at 24 hours after the first dose of VX-150 or placebo were reported.</description>
        <time_frame>From Baseline at 24 Hours After First Dose</time_frame>
        <population>FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to VX-150 for 2 days.</description>
          </group>
          <group group_id="O2">
            <title>VX-150 - Dose Level 1</title>
            <description>Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.</description>
          </group>
          <group group_id="O3">
            <title>VX-150 - Dose Level 2</title>
            <description>Participants received VX-150 1000 mg qd for 2 days.</description>
          </group>
          <group group_id="O4">
            <title>VX-150 - Dose Level 3</title>
            <description>Participants received VX-150 500 mg q12h for 2 days.</description>
          </group>
          <group group_id="O5">
            <title>VX-150 - Dose Level 4</title>
            <description>Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.</description>
          </group>
          <group group_id="O6">
            <title>VX-150 - Dose Level 5</title>
            <description>Participants received VX-150 250 mg qd for 2 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With at Least 50% Reduction in NPRS at 24 Hours After the First Dose of VX-150 Versus Placebo</title>
          <description>Pain intensity was recorded on 11-point ordinal NPRS, score range: 0 to 10, where 0=no pain and 10=worst imaginable pain. The percentage of participants with at least 50% reduction from baseline in NPRS at 24 hours after the first dose of VX-150 or placebo were reported.</description>
          <population>FAS.</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="46"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="45"/>
                <count group_id="O5" value="46"/>
                <count group_id="O6" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.3"/>
                    <measurement group_id="O2" value="38.1"/>
                    <measurement group_id="O3" value="45.5"/>
                    <measurement group_id="O4" value="44.4"/>
                    <measurement group_id="O5" value="45.7"/>
                    <measurement group_id="O6" value="40.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8714</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5815</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4308</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4434</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8550</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With at Least 70% Reduction in NPRS at 24 Hours After the First Dose of VX-150 Versus Placebo</title>
        <description>Pain intensity was recorded on 11-point ordinal NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The percentage of participants with at least 70% reduction from baseline in NPRS at 24 hours after the first dose of VX-150 or placebo were reported.</description>
        <time_frame>From Baseline at 24 Hours After First Dose</time_frame>
        <population>FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to VX-150 for 2 days.</description>
          </group>
          <group group_id="O2">
            <title>VX-150 - Dose Level 1</title>
            <description>Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.</description>
          </group>
          <group group_id="O3">
            <title>VX-150 - Dose Level 2</title>
            <description>Participants received VX-150 1000 mg qd for 2 days.</description>
          </group>
          <group group_id="O4">
            <title>VX-150 - Dose Level 3</title>
            <description>Participants received VX-150 500 mg q12h for 2 days.</description>
          </group>
          <group group_id="O5">
            <title>VX-150 - Dose Level 4</title>
            <description>Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.</description>
          </group>
          <group group_id="O6">
            <title>VX-150 - Dose Level 5</title>
            <description>Participants received VX-150 250 mg qd for 2 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With at Least 70% Reduction in NPRS at 24 Hours After the First Dose of VX-150 Versus Placebo</title>
          <description>Pain intensity was recorded on 11-point ordinal NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The percentage of participants with at least 70% reduction from baseline in NPRS at 24 hours after the first dose of VX-150 or placebo were reported.</description>
          <population>FAS.</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="46"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="45"/>
                <count group_id="O5" value="46"/>
                <count group_id="O6" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.7"/>
                    <measurement group_id="O2" value="21.4"/>
                    <measurement group_id="O3" value="34.1"/>
                    <measurement group_id="O4" value="22.2"/>
                    <measurement group_id="O5" value="30.4"/>
                    <measurement group_id="O6" value="18.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6870</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1515</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6030</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1361</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5640</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Onset of Confirmed Perceptible Pain Relief After First Dose of VX-150 Versus Placebo</title>
        <description>Time to onset of confirmed perceptible pain relief (time to onset of perceptible pain relief [any pain relief at all after the first dose] for participants who had meaningful pain relief [relief that is meaningful to participants after the first dose] reported based on the stopwatch assessment.</description>
        <time_frame>Up to 6 hours After the First Dose</time_frame>
        <population>FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to VX-150 for 2 days.</description>
          </group>
          <group group_id="O2">
            <title>VX-150 - Dose Level 1</title>
            <description>Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.</description>
          </group>
          <group group_id="O3">
            <title>VX-150 - Dose Level 2</title>
            <description>Participants received VX-150 1000 mg qd for 2 days.</description>
          </group>
          <group group_id="O4">
            <title>VX-150 - Dose Level 3</title>
            <description>Participants received VX-150 500 mg q12h for 2 days.</description>
          </group>
          <group group_id="O5">
            <title>VX-150 - Dose Level 4</title>
            <description>Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.</description>
          </group>
          <group group_id="O6">
            <title>VX-150 - Dose Level 5</title>
            <description>Participants received VX-150 250 mg qd for 2 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Onset of Confirmed Perceptible Pain Relief After First Dose of VX-150 Versus Placebo</title>
          <description>Time to onset of confirmed perceptible pain relief (time to onset of perceptible pain relief [any pain relief at all after the first dose] for participants who had meaningful pain relief [relief that is meaningful to participants after the first dose] reported based on the stopwatch assessment.</description>
          <population>FAS.</population>
          <units>minutes</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="45"/>
                <count group_id="O5" value="46"/>
                <count group_id="O6" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.4" lower_limit="6" upper_limit="67"/>
                    <measurement group_id="O2" value="29.6" lower_limit="6" upper_limit="115"/>
                    <measurement group_id="O3" value="23.8" lower_limit="11" upper_limit="92"/>
                    <measurement group_id="O4" value="20.2" lower_limit="7" upper_limit="103"/>
                    <measurement group_id="O5" value="35.6" lower_limit="2" upper_limit="112"/>
                    <measurement group_id="O6" value="25.2" lower_limit="17" upper_limit="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5405</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.60</ci_lower_limit>
            <ci_upper_limit>2.67</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9011</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.49</ci_lower_limit>
            <ci_upper_limit>2.27</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9127</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.48</ci_lower_limit>
            <ci_upper_limit>2.26</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5619</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.60</ci_lower_limit>
            <ci_upper_limit>2.56</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7090</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.50</ci_lower_limit>
            <ci_upper_limit>2.79</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Onset of Meaningful Pain Relief After the First Dose of VX-150 Versus Placebo</title>
        <description>Time to onset of meaningful pain relief (relief that is meaningful to participants after the first dose) reported based on the stopwatch assessment.</description>
        <time_frame>Up to 6 Hours After the First Dose</time_frame>
        <population>FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to VX-150 for 2 days.</description>
          </group>
          <group group_id="O2">
            <title>VX-150 - Dose Level 1</title>
            <description>Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.</description>
          </group>
          <group group_id="O3">
            <title>VX-150 - Dose Level 2</title>
            <description>Participants received VX-150 1000 mg qd for 2 days.</description>
          </group>
          <group group_id="O4">
            <title>VX-150 - Dose Level 3</title>
            <description>Participants received VX-150 500 mg q12h for 2 days.</description>
          </group>
          <group group_id="O5">
            <title>VX-150 - Dose Level 4</title>
            <description>Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.</description>
          </group>
          <group group_id="O6">
            <title>VX-150 - Dose Level 5</title>
            <description>Participants received VX-150 250 mg qd for 2 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Onset of Meaningful Pain Relief After the First Dose of VX-150 Versus Placebo</title>
          <description>Time to onset of meaningful pain relief (relief that is meaningful to participants after the first dose) reported based on the stopwatch assessment.</description>
          <population>FAS.</population>
          <units>minutes</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="45"/>
                <count group_id="O5" value="46"/>
                <count group_id="O6" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.4" lower_limit="19" upper_limit="102"/>
                    <measurement group_id="O2" value="58.7" lower_limit="16" upper_limit="175"/>
                    <measurement group_id="O3" value="68.6" lower_limit="15" upper_limit="255"/>
                    <measurement group_id="O4" value="49.9" lower_limit="20" upper_limit="355"/>
                    <measurement group_id="O5" value="61.5" lower_limit="10" upper_limit="294"/>
                    <measurement group_id="O6" value="64.5" lower_limit="30" upper_limit="162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5141</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.61</ci_lower_limit>
            <ci_upper_limit>2.72</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9614</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.45</ci_lower_limit>
            <ci_upper_limit>2.12</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9756</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.46</ci_lower_limit>
            <ci_upper_limit>2.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5582</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.60</ci_lower_limit>
            <ci_upper_limit>2.57</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7543</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.49</ci_lower_limit>
            <ci_upper_limit>2.71</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Concentration (Cmax) of VRT- 1207355 (Active Moiety) and VRT- 1268114 (Metabolite M5)</title>
        <time_frame>Day 1 and Day 2</time_frame>
        <population>Pharmacokinetic (PK) set included all randomized participants who received at least 1 dose of study drug. Here, &quot;number analyzed&quot; signifies those participants who were evaluable at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>VX-150 - Dose Level 1</title>
            <description>Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.</description>
          </group>
          <group group_id="O2">
            <title>VX-150 - Dose Level 2</title>
            <description>Participants received VX-150 1000 mg qd for 2 days.</description>
          </group>
          <group group_id="O3">
            <title>VX-150 - Dose Level 3</title>
            <description>Participants received VX-150 500 mg q12h for 2 days.</description>
          </group>
          <group group_id="O4">
            <title>VX-150 - Dose Level 4</title>
            <description>Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.</description>
          </group>
          <group group_id="O5">
            <title>VX-150 - Dose Level 5</title>
            <description>Participants received VX-150 250 mg qd for 2 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Concentration (Cmax) of VRT- 1207355 (Active Moiety) and VRT- 1268114 (Metabolite M5)</title>
          <population>Pharmacokinetic (PK) set included all randomized participants who received at least 1 dose of study drug. Here, &quot;number analyzed&quot; signifies those participants who were evaluable at specified time points.</population>
          <units>micrograms per milliliter (mcg/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="42"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="45"/>
                <count group_id="O4" value="46"/>
                <count group_id="O5" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>VRT- 1207355: Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="40"/>
                    <count group_id="O3" value="43"/>
                    <count group_id="O4" value="43"/>
                    <count group_id="O5" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.97" spread="1.67"/>
                    <measurement group_id="O2" value="3.27" spread="1.35"/>
                    <measurement group_id="O3" value="1.71" spread="0.536"/>
                    <measurement group_id="O4" value="1.89" spread="0.641"/>
                    <measurement group_id="O5" value="0.794" spread="0.241"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VRT- 1207355: Day 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="42"/>
                    <count group_id="O4" value="44"/>
                    <count group_id="O5" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.93" spread="1.38"/>
                    <measurement group_id="O2" value="4.17" spread="1.53"/>
                    <measurement group_id="O3" value="3.00" spread="0.979"/>
                    <measurement group_id="O4" value="1.95" spread="0.708"/>
                    <measurement group_id="O5" value="0.974" spread="0.305"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VRT- 1268114: Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="43"/>
                    <count group_id="O4" value="43"/>
                    <count group_id="O5" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.79" spread="0.637"/>
                    <measurement group_id="O2" value="1.31" spread="0.602"/>
                    <measurement group_id="O3" value="0.699" spread="0.261"/>
                    <measurement group_id="O4" value="0.719" spread="0.341"/>
                    <measurement group_id="O5" value="0.295" spread="0.128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VRT- 1268114: Day 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="42"/>
                    <count group_id="O4" value="44"/>
                    <count group_id="O5" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.68" spread="0.944"/>
                    <measurement group_id="O2" value="1.87" spread="0.779"/>
                    <measurement group_id="O3" value="1.65" spread="0.544"/>
                    <measurement group_id="O4" value="1.11" spread="0.437"/>
                    <measurement group_id="O5" value="0.408" spread="0.153"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VRT- 1207355 and VRT- 1268114</title>
        <time_frame>Day 1 and Day 2</time_frame>
        <population>PK set. Here, &quot;number analyzed&quot; signifies those participants who were evaluable at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>VX-150 - Dose Level 1</title>
            <description>Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.</description>
          </group>
          <group group_id="O2">
            <title>VX-150 - Dose Level 2</title>
            <description>Participants received VX-150 1000 mg qd for 2 days.</description>
          </group>
          <group group_id="O3">
            <title>VX-150 - Dose Level 3</title>
            <description>Participants received VX-150 500 mg q12h for 2 days.</description>
          </group>
          <group group_id="O4">
            <title>VX-150 - Dose Level 4</title>
            <description>Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.</description>
          </group>
          <group group_id="O5">
            <title>VX-150 - Dose Level 5</title>
            <description>Participants received VX-150 250 mg qd for 2 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VRT- 1207355 and VRT- 1268114</title>
          <population>PK set. Here, &quot;number analyzed&quot; signifies those participants who were evaluable at specified time points.</population>
          <units>microgram*hour per milliliter (mcg*h/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="42"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="45"/>
                <count group_id="O4" value="46"/>
                <count group_id="O5" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>VRT- 1207355: Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="40"/>
                    <count group_id="O3" value="42"/>
                    <count group_id="O4" value="43"/>
                    <count group_id="O5" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.7" spread="13.4"/>
                    <measurement group_id="O2" value="25.7" spread="11.0"/>
                    <measurement group_id="O3" value="13.6" spread="4.60"/>
                    <measurement group_id="O4" value="14.6" spread="4.73"/>
                    <measurement group_id="O5" value="5.99" spread="1.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VRT- 1207355: Day 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="42"/>
                    <count group_id="O4" value="44"/>
                    <count group_id="O5" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.1" spread="14.0"/>
                    <measurement group_id="O2" value="36.1" spread="12.8"/>
                    <measurement group_id="O3" value="27.1" spread="8.40"/>
                    <measurement group_id="O4" value="17.7" spread="6.01"/>
                    <measurement group_id="O5" value="8.24" spread="2.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VRT- 1268114: Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="42"/>
                    <count group_id="O4" value="43"/>
                    <count group_id="O5" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.7" spread="4.40"/>
                    <measurement group_id="O2" value="10.2" spread="4.84"/>
                    <measurement group_id="O3" value="5.55" spread="2.04"/>
                    <measurement group_id="O4" value="5.48" spread="2.58"/>
                    <measurement group_id="O5" value="2.27" spread="1.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VRT- 1268114: Day 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="42"/>
                    <count group_id="O4" value="44"/>
                    <count group_id="O5" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.8" spread="9.60"/>
                    <measurement group_id="O2" value="17.6" spread="7.33"/>
                    <measurement group_id="O3" value="16.2" spread="4.72"/>
                    <measurement group_id="O4" value="10.8" spread="4.19"/>
                    <measurement group_id="O5" value="3.84" spread="1.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
        <time_frame>Day 1 up to Day 10</time_frame>
        <population>Safety set included all participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to VX-150 for 2 days.</description>
          </group>
          <group group_id="O2">
            <title>VX-150 - Dose Level 1</title>
            <description>Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.</description>
          </group>
          <group group_id="O3">
            <title>VX-150 - Dose Level 2</title>
            <description>Participants received VX-150 1000 mg qd for 2 days.</description>
          </group>
          <group group_id="O4">
            <title>VX-150 - Dose Level 3</title>
            <description>Participants received VX-150 500 mg q12h for 2 days.</description>
          </group>
          <group group_id="O5">
            <title>VX-150 - Dose Level 4</title>
            <description>Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.</description>
          </group>
          <group group_id="O6">
            <title>VX-150 - Dose Level 5</title>
            <description>Participants received VX-150 250 mg qd for 2 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
          <population>Safety set included all participants who received at least 1 dose of study drug.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="45"/>
                <count group_id="O5" value="46"/>
                <count group_id="O6" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants With AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="19"/>
                    <measurement group_id="O4" value="18"/>
                    <measurement group_id="O5" value="19"/>
                    <measurement group_id="O6" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants With SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Day 1 up to Day 10</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants received placebo matched to VX-150 for 2 days.</description>
        </group>
        <group group_id="E2">
          <title>VX-150 - Dose Level 1</title>
          <description>Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.</description>
        </group>
        <group group_id="E3">
          <title>VX-150 - Dose Level 2</title>
          <description>Participants received VX-150 1000 mg qd for 2 days.</description>
        </group>
        <group group_id="E4">
          <title>VX-150 - Dose Level 3</title>
          <description>Participants received VX-150 500 mg q12h for 2 days.</description>
        </group>
        <group group_id="E5">
          <title>VX-150 - Dose Level 4</title>
          <description>Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.</description>
        </group>
        <group group_id="E6">
          <title>VX-150 - Dose Level 5</title>
          <description>Participants received VX-150 250 mg qd for 2 days.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="44"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="45"/>
                <counts group_id="E5" subjects_affected="12" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="44"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="45"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="44"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="45"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="27"/>
              </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>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Monitor</name_or_title>
      <organization>Vertex Pharmaceuticals Incorporated</organization>
      <phone>617-341-6777</phone>
      <email>medicalinfo@vrtx.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/NCT03764072
org study id: VX18-150-104
nct id: NCT03764072
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study will evaluate the dose-response relationship and safety of VX-150 in treating
      acute pain following bunionectomy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Time-weighted Sum of the Pain Intensity Difference as Recorded on Numeric Pain Rating Scale (NPRS) 0 to 24 Hours (SPID24) After First Dose
time frame: 0 to 24 Hours After First Dose
description: SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the pain intensity score at given post-dose time points from the baseline pain intensity scores (using pain rating score range: 0= no pain to 10= worst possible pain). SPID24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score).
measure: Time-weighted Sum of Pain Intensity Difference as Recorded on NPRS 0 to 48 Hours (SPID48) After First Dose
time frame: 0 to 48 Hours After First Dose
description: SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the pain intensity score at given post-dose time points from the baseline pain intensity scores (using pain rating score range: 0= no pain to 10= worst possible pain). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).
measure: Proportion of Participants With at Least 30 Percent (%) Reduction in NPRS at 24 Hours After First Dose of VX-150 Versus Placebo
time frame: From Baseline at 24 Hours After First Dose
description: Pain intensity was recorded on 11-point ordinal NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The percentage of participants with at least 30% reduction from baseline in NPRS at 24 hours after the first dose of VX-150 or placebo were reported.
measure: Proportion of Participants With at Least 50% Reduction in NPRS at 24 Hours After the First Dose of VX-150 Versus Placebo
time frame: From Baseline at 24 Hours After First Dose
description: Pain intensity was recorded on 11-point ordinal NPRS, score range: 0 to 10, where 0=no pain and 10=worst imaginable pain. The percentage of participants with at least 50% reduction from baseline in NPRS at 24 hours after the first dose of VX-150 or placebo were reported.
measure: Proportion of Participants With at Least 70% Reduction in NPRS at 24 Hours After the First Dose of VX-150 Versus Placebo
time frame: From Baseline at 24 Hours After First Dose
description: Pain intensity was recorded on 11-point ordinal NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The percentage of participants with at least 70% reduction from baseline in NPRS at 24 hours after the first dose of VX-150 or placebo were reported.
measure: Time to Onset of Confirmed Perceptible Pain Relief After First Dose of VX-150 Versus Placebo
time frame: Up to 6 hours After the First Dose
description: Time to onset of confirmed perceptible pain relief (time to onset of perceptible pain relief [any pain relief at all after the first dose] for participants who had meaningful pain relief [relief that is meaningful to participants after the first dose] reported based on the stopwatch assessment.
measure: Time to Onset of Meaningful Pain Relief After the First Dose of VX-150 Versus Placebo
time frame: Up to 6 Hours After the First Dose
description: Time to onset of meaningful pain relief (relief that is meaningful to participants after the first dose) reported based on the stopwatch assessment.
measure: Maximum Observed Concentration (Cmax) of VRT- 1207355 (Active Moiety) and VRT- 1268114 (Metabolite M5)
time frame: Day 1 and Day 2
measure: Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VRT- 1207355 and VRT- 1268114
time frame: Day 1 and Day 2
measure: Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: Day 1 up to Day 10
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants received placebo matched to VX-150 for 2 days.
arm group label: VX-150 - Dose Level 1
arm group type: Experimental
description: Participants received VX-150 1500 milligrams (mg) as first dose, followed by VX-150 750 mg every 12 hours (q12h) for 2 days.
arm group label: VX-150 - Dose Level 2
arm group type: Experimental
description: Participants received VX-150 1000 mg once daily (qd) for 2 days.
arm group label: VX-150 - Dose Level 3
arm group type: Experimental
description: Participants received VX-150 500 mg q12h for 2 days.
arm group label: VX-150 - Dose Level 4
arm group type: Experimental
description: Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.
arm group label: VX-150 - Dose Level 5
arm group type: Experimental
description: Participants received VX-150 250 mg qd for 2 days.
intervention type: Drug
intervention name: VX-150
description: Capsules for oral administration.
arm group label: VX-150 - Dose Level 1
arm group label: VX-150 - Dose Level 2
arm group label: VX-150 - Dose Level 3
arm group label: VX-150 - Dose Level 4
arm group label: VX-150 - Dose Level 5
intervention type: Drug
intervention name: Placebo
description: Capsules for oral administration.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acute Pain
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 