<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/NCT03295721</url>
  </required_header>
  <id_info>
    <org_study_id>HTX-011-301</org_study_id>
    <nct_id>NCT03295721</nct_id>
  </id_info>
  <brief_title>Bunionectomy Study for Postoperative Analgesia (EPOCH 1)</brief_title>
  <official_title>A Phase 3, Randomized, Double Blind, Saline Placebo and Active Controlled, Multicenter Study of HTX 011 Via Local Administration for Postoperative Analgesia and Decreased Opioid Use Following Unilateral Simple Bunionectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heron Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Heron Therapeutics</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled,&#xD;
      multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via&#xD;
      local administration into the surgical site in subjects undergoing bunionectomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 24, 2017</start_date>
  <completion_date type="Actual">March 13, 2018</completion_date>
  <primary_completion_date type="Actual">January 8, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Area Under the Curve (AUC) of the Numeric Rating Scale of Pain Intensity Scores With Activity (NRS-A; Windowed Worst Observation Carried Forward) for HTX-011 Compared With Saline Placebo.</measure>
    <time_frame>72 hours</time_frame>
    <description>Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents &quot;no pain&quot; and 10 represents &quot;worst pain imaginable&quot;. NRS scores are recorded with activity (NRS-A), seated with the plantar surface of the ball of the surgically attended foot touching the floor (no weight-bearing).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean AUC of the NRS-A Pain Intensity Scores (Windowed Worst Observation Carried Forward) for HTX 011 Compared With Bupivacaine HCl.</measure>
    <time_frame>72 hours</time_frame>
    <description>Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents &quot;no pain&quot; and 10 represents &quot;worst pain imaginable&quot;. NRS scores are recorded with activity (NRS-A) seated with the plantar surface of the ball of the surgically attended foot touching the floor (no weight-bearing).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Saline Placebo.</measure>
    <time_frame>72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Who Are Opioid-free for HTX-011 Compared With Bupivacaine HCl.</measure>
    <time_frame>72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Bupivacaine HCl.</measure>
    <time_frame>72 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">412</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Treatment Group 1: HTX-011</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HTX 011 (bupivacaine/meloxicam)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Group 2: Saline Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Group 3: Bupivacaine HCI</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bupivacaine HCl</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HTX-011</intervention_name>
    <description>HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation</description>
    <arm_group_label>Treatment Group 1: HTX-011</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline Placebo</intervention_name>
    <description>Saline placebo by instillation</description>
    <arm_group_label>Treatment Group 2: Saline Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine HCl</intervention_name>
    <description>Bupivacaine HCl without epinephrine, 50 mg by injection</description>
    <arm_group_label>Treatment Group 3: Bupivacaine HCI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Luer-lock applicator</intervention_name>
    <description>Applicator for instillation</description>
    <arm_group_label>Treatment Group 1: HTX-011</arm_group_label>
    <arm_group_label>Treatment Group 2: Saline Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vial access device</intervention_name>
    <description>Device for withdrawal of drug product</description>
    <arm_group_label>Treatment Group 1: HTX-011</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Is scheduled to undergo a primary unilateral, distal, first metatarsal bunionectomy&#xD;
             with osteotomy and internal fixation under regional anesthesia.&#xD;
&#xD;
          -  Has an American Society of Anesthesiologists Physical Status of I, II, or III.&#xD;
&#xD;
          -  Female subjects are eligible only if not pregnant, not lactating, not planning to&#xD;
             become pregnant during the study, sterile; or using acceptable contraceptives.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has had a contralateral foot bunionectomy in the past 3 months.&#xD;
&#xD;
          -  Has a planned concurrent surgical procedure (eg, bilateral bunionectomy or collateral&#xD;
             procedures on the surgical foot).&#xD;
&#xD;
          -  Has other pre existing concurrent acute or chronic painful physical/restrictive&#xD;
             condition expected to require analgesic treatment in the postoperative period for&#xD;
             pain.&#xD;
&#xD;
          -  Has a contraindication or a known or suspected history of hypersensitivity or&#xD;
             clinically significant idiosyncratic reaction to required study medications.&#xD;
&#xD;
          -  Has known or suspected daily use of opioids for 7 or more consecutive days within the&#xD;
             previous 6 months.&#xD;
&#xD;
          -  Has taken any NSAIDs within at least 10 days prior to the scheduled surgery.&#xD;
&#xD;
          -  Has taken opioids within 24 hours prior to the scheduled surgery (3 days for&#xD;
             long-acting).&#xD;
&#xD;
          -  Has been administered bupivacaine within 5 days prior to the scheduled surgery.&#xD;
&#xD;
          -  Has initiated treatment with medications within 1 month prior to study drug&#xD;
             administration that can impact pain control.&#xD;
&#xD;
          -  Has been administered systemic steroids within 5 half-lives or 10 days prior to&#xD;
             administration of study drug.&#xD;
&#xD;
          -  Has a medical condition such that, in the opinion of the Investigator, participating&#xD;
             in the study would pose a health risk to the subject or confound the postoperative&#xD;
             assessments.&#xD;
&#xD;
          -  As per subject history and/or medical records, has active infection or is currently&#xD;
             undergoing treatment for Hepatitis B, Hepatitis C, or human immunodeficiency virus&#xD;
             (HIV).&#xD;
&#xD;
          -  Has uncontrolled anxiety, psychiatric, or neurological disorder.&#xD;
&#xD;
          -  Had a malignancy in the last year, with the exception of nonmetastatic basal cell or&#xD;
             squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.&#xD;
&#xD;
          -  Has a known or suspected history of drug abuse, a positive drug screen on the day of&#xD;
             surgery, or a recent history of alcohol abuse. Note: Subjects with a positive drug&#xD;
             screen who are taking an allowed, prescribed medication that is known to result in a&#xD;
             positive drug test (eg, amphetamine and dextroamphetamine for attention&#xD;
             deficit/hyperactivity disorder, benzodiazepine for anxiety disorder) may be eligible&#xD;
             for participation in the study. Subjects taking medical marijuana are not allowed to&#xD;
             participate in the study.&#xD;
&#xD;
          -  Received an investigational product or device in a clinical trial within 30 days or&#xD;
             within 5 elimination half lives.&#xD;
&#xD;
          -  Has undergone 3 or more surgeries within 12 months.&#xD;
&#xD;
          -  Has a body mass index (BMI) &gt;39 kg/m2.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Springhill Medical Center</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopaedic Specialists of North America, PLLC</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Research Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85059</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anaheim Clinical Trials, LLC</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trovare Clinical Research, Inc.</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance Research Centers</name>
      <address>
        <city>Laguna Hills</city>
        <state>California</state>
        <zip>92653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chesapeake Research Group, LLC</name>
      <address>
        <city>Pasadena</city>
        <state>Maryland</state>
        <zip>21122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Optimal Research , LLC</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hermann Drive Surgical Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westside Surgical Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Futuro Clinical Trials, LLC</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Plano Surgical Hospital</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</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>EPIC Medical Research, LLC</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jean Brown Research</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <results_first_submitted>June 11, 2021</results_first_submitted>
  <results_first_submitted_qc>September 29, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 27, 2021</results_first_posted>
  <disposition_first_submitted>June 8, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>September 29, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">October 27, 2021</disposition_first_posted>
  <last_update_submitted>September 29, 2021</last_update_submitted>
  <last_update_submitted_qc>September 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bunion</keyword>
  <keyword>bunionectomy</keyword>
  <keyword>bunion surgery</keyword>
  <keyword>postoperative pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_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 24, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT03295721/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>October 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT03295721/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Treatment Group 1: HTX-011</title>
          <description>HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation.</description>
        </group>
        <group group_id="P2">
          <title>Treatment Group 2: Saline Placebo</title>
          <description>Saline placebo by instillation.</description>
        </group>
        <group group_id="P3">
          <title>Treatment Group 3: Bupivacaine HCI</title>
          <description>Bupivacaine HCl without epinephrine, 50 mg by injection.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="157"/>
                <participants group_id="P2" count="100"/>
                <participants group_id="P3" count="155"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="154"/>
                <participants group_id="P2" count="99"/>
                <participants group_id="P3" count="152"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treatment Group 1: HTX-011</title>
          <description>HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation.</description>
        </group>
        <group group_id="B2">
          <title>Treatment Group 2: Saline Placebo</title>
          <description>Saline placebo by instillation.</description>
        </group>
        <group group_id="B3">
          <title>Treatment Group 3: Bupivacaine HCI</title>
          <description>Bupivacaine HCl without epinephrine, 50 mg by injection.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="157"/>
            <count group_id="B2" value="100"/>
            <count group_id="B3" value="155"/>
            <count group_id="B4" value="412"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="133"/>
                    <measurement group_id="B2" value="92"/>
                    <measurement group_id="B3" value="139"/>
                    <measurement group_id="B4" value="364"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="48.0" spread="14.47"/>
                    <measurement group_id="B2" value="47.3" spread="12.83"/>
                    <measurement group_id="B3" value="45.5" spread="14.79"/>
                    <measurement group_id="B4" value="46.9" spread="14.22"/>
                  </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="138"/>
                    <measurement group_id="B2" value="86"/>
                    <measurement group_id="B3" value="132"/>
                    <measurement group_id="B4" value="356"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="56"/>
                  </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="47"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="49"/>
                    <measurement group_id="B4" value="128"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="110"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="106"/>
                    <measurement group_id="B4" value="284"/>
                  </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_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="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="11"/>
                  </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="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="123"/>
                    <measurement group_id="B2" value="86"/>
                    <measurement group_id="B3" value="128"/>
                    <measurement group_id="B4" value="337"/>
                  </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="2"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="157"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="155"/>
                    <measurement group_id="B4" value="412"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Area Under the Curve (AUC) of the Numeric Rating Scale of Pain Intensity Scores With Activity (NRS-A; Windowed Worst Observation Carried Forward) for HTX-011 Compared With Saline Placebo.</title>
        <description>Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents &quot;no pain&quot; and 10 represents &quot;worst pain imaginable&quot;. NRS scores are recorded with activity (NRS-A), seated with the plantar surface of the ball of the surgically attended foot touching the floor (no weight-bearing).</description>
        <time_frame>72 hours</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group 1: HTX-011</title>
            <description>HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Group 2: Saline Placebo</title>
            <description>Saline placebo by instillation.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Area Under the Curve (AUC) of the Numeric Rating Scale of Pain Intensity Scores With Activity (NRS-A; Windowed Worst Observation Carried Forward) for HTX-011 Compared With Saline Placebo.</title>
          <description>Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents &quot;no pain&quot; and 10 represents &quot;worst pain imaginable&quot;. NRS scores are recorded with activity (NRS-A), seated with the plantar surface of the ball of the surgically attended foot touching the floor (no weight-bearing).</description>
          <population>ITT Population</population>
          <units>pain intensity score*hr</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="157"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="323.29" spread="182.641"/>
                    <measurement group_id="O2" value="445.34" spread="155.792"/>
                  </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>&lt; 0.0001</p_value>
            <method>ANOVA</method>
            <param_type>Least Squares Mean Difference (LSMD)</param_type>
            <param_value>-122.05</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>21.217</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-163.76</ci_lower_limit>
            <ci_upper_limit>-80.34</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean AUC of the NRS-A Pain Intensity Scores (Windowed Worst Observation Carried Forward) for HTX 011 Compared With Bupivacaine HCl.</title>
        <description>Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents &quot;no pain&quot; and 10 represents &quot;worst pain imaginable&quot;. NRS scores are recorded with activity (NRS-A) seated with the plantar surface of the ball of the surgically attended foot touching the floor (no weight-bearing).</description>
        <time_frame>72 hours</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group 1: HTX-011</title>
            <description>HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Group 3: Bupivacaine HCI</title>
            <description>Bupivacaine HCl without epinephrine, 50 mg by injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean AUC of the NRS-A Pain Intensity Scores (Windowed Worst Observation Carried Forward) for HTX 011 Compared With Bupivacaine HCl.</title>
          <description>Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents &quot;no pain&quot; and 10 represents &quot;worst pain imaginable&quot;. NRS scores are recorded with activity (NRS-A) seated with the plantar surface of the ball of the surgically attended foot touching the floor (no weight-bearing).</description>
          <population>ITT Population</population>
          <units>pain intensity score*hr</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="157"/>
                <count group_id="O2" value="155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="323.29" spread="182.641"/>
                    <measurement group_id="O2" value="393.45" spread="153.756"/>
                  </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>= 0.0002</p_value>
            <method>ANOVA</method>
            <param_type>Least Squares Mean Difference (LSMD)</param_type>
            <param_value>-70.16</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>18.777</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-107.07</ci_lower_limit>
            <ci_upper_limit>-33.25</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Saline Placebo.</title>
        <time_frame>72 hours</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group 1: HTX-011</title>
            <description>HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Group 2: Saline Placebo</title>
            <description>Saline placebo by instillation.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Saline Placebo.</title>
          <population>ITT Population</population>
          <units>IV milligram morphine equivalent (MME)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="157"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.80" spread="19.801"/>
                    <measurement group_id="O2" value="30.06" spread="21.016"/>
                  </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>&lt; 0.0001</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Who Are Opioid-free for HTX-011 Compared With Bupivacaine HCl.</title>
        <time_frame>72 hours</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group 1: HTX-011</title>
            <description>HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Group 3: Bupivacaine HCI</title>
            <description>Bupivacaine HCl without epinephrine, 50 mg by injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Who Are Opioid-free for HTX-011 Compared With Bupivacaine HCl.</title>
          <population>ITT Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="157"/>
                <count group_id="O2" value="155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="17"/>
                  </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>0.0001</p_value>
            <method>Fisher Exact</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>.177</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>.085</ci_lower_limit>
            <ci_upper_limit>.265</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Bupivacaine HCl.</title>
        <time_frame>72 hours</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group 1: HTX-011</title>
            <description>HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Group 3: Bupivacaine HCl</title>
            <description>Bupivacaine HCl without epinephrine, 50 mg by injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Bupivacaine HCl.</title>
          <population>ITT Population</population>
          <units>IV milligram morphine equivalent (MME)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="157"/>
                <count group_id="O2" value="155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.80" spread="19.801"/>
                    <measurement group_id="O2" value="25.09" spread="21.553"/>
                  </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>= 0.0022</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>42 days.</time_frame>
      <desc>For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.</desc>
      <group_list>
        <group group_id="E1">
          <title>Treatment Group 1: HTX-011</title>
          <description>HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation.</description>
        </group>
        <group group_id="E2">
          <title>Treatment Group 2: Saline Placebo</title>
          <description>Saline placebo by instillation.&#xD;
1 subject was randomized to bupivacaine HCl, but received saline placebo. (Ie, ITT = 100 and Safety population = 101).</description>
        </group>
        <group group_id="E3">
          <title>Treatment Group 3: Bupivacaine HCl</title>
          <description>Bupivacaine HCl without epinephrine, 50 mg by injection.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Intestinal perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct stone</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Thoracic vertebral fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Venous thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis postoperative</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="111" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="70" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="112" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Sinus arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="59" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="44" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="70" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="33" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Impaired healing</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Incision site oedema</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="22" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Incision site erythema</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Post procedural contusion</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle twitching</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="36" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="20" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Pruritus generalised</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Vice President, Clinical Operations</name_or_title>
      <organization>Heron Therapeutics, Inc.</organization>
      <phone>855-251-7232</phone>
      <email>svisonneau@herontx.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/NCT03295721
org study id: HTX-011-301
nct id: NCT03295721
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: Yes
is us export: Yes
This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled,
      multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via
      local administration into the surgical site in subjects undergoing bunionectomy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Mean Area Under the Curve (AUC) of the Numeric Rating Scale of Pain Intensity Scores With Activity (NRS-A; Windowed Worst Observation Carried Forward) for HTX-011 Compared With Saline Placebo.
time frame: 72 hours
description: Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". NRS scores are recorded with activity (NRS-A), seated with the plantar surface of the ball of the surgically attended foot touching the floor (no weight-bearing).
measure: Mean AUC of the NRS-A Pain Intensity Scores (Windowed Worst Observation Carried Forward) for HTX 011 Compared With Bupivacaine HCl.
time frame: 72 hours
description: Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". NRS scores are recorded with activity (NRS-A) seated with the plantar surface of the ball of the surgically attended foot touching the floor (no weight-bearing).
measure: Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Saline Placebo.
time frame: 72 hours
measure: Percentage of Subjects Who Are Opioid-free for HTX-011 Compared With Bupivacaine HCl.
time frame: 72 hours
measure: Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Bupivacaine HCl.
time frame: 72 hours
arm group label: Treatment Group 1: HTX-011
arm group type: Experimental
description: HTX 011 (bupivacaine/meloxicam)
arm group label: Treatment Group 2: Saline Placebo
arm group type: Placebo Comparator
description: Saline placebo
arm group label: Treatment Group 3: Bupivacaine HCI
arm group type: Active Comparator
description: Bupivacaine HCl
intervention type: Drug
intervention name: HTX-011
description: HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation
arm group label: Treatment Group 1: HTX-011
intervention type: Drug
intervention name: Saline Placebo
description: Saline placebo by instillation
arm group label: Treatment Group 2: Saline Placebo
intervention type: Drug
intervention name: Bupivacaine HCl
description: Bupivacaine HCl without epinephrine, 50 mg by injection
arm group label: Treatment Group 3: Bupivacaine HCI
intervention type: Device
intervention name: Luer-lock applicator
description: Applicator for instillation
arm group label: Treatment Group 1: HTX-011
arm group label: Treatment Group 2: Saline Placebo
intervention type: Device
intervention name: Vial access device
description: Device for withdrawal of drug product
arm group label: Treatment Group 1: HTX-011
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Bupivacaine
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 