<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/NCT03281577</url>
  </required_header>
  <id_info>
    <org_study_id>TAK-954-2003</org_study_id>
    <secondary_id>U1111-1200-9396</secondary_id>
    <nct_id>NCT03281577</nct_id>
  </id_info>
  <brief_title>Effect of TAK-954 on Gastrointestinal and Colonic Transit in Diabetic or Idiopathic Gastroparesis Participants</brief_title>
  <official_title>A Dose-Ranging, Randomized, Parallel, Placebo-Controlled Study to Assess the Effect of TAK-954 on Gastrointestinal and Colonic Transit in Patients With Diabetic or Idiopathic Gastroparesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the dose-dependent effects of TAK-954 on gastric&#xD;
      emptying time of solids in participants with diabetic or idiopathic gastroparesis assessed by&#xD;
      scintigraphy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The drug being tested in this study is called TAK-954. TAK-954 is a serotonin (5 HT4)&#xD;
      receptor agonist and is being tested to treat people who have diabetic or idiopathic&#xD;
      gastroparesis and who previously reported delay in stomach emptying. This study will look at&#xD;
      the gastric emptying time of solids in people who take TAK-954 or placebo.&#xD;
&#xD;
      The study will enroll approximately 41 patients. Participants will be randomly assigned (by&#xD;
      chance, like flipping a coin) to one of the four treatment groups-which will remain&#xD;
      undisclosed to the participant and study doctor during the study (unless there is an urgent&#xD;
      medical need):&#xD;
&#xD;
        -  TAK-954 0.1 mg&#xD;
&#xD;
        -  TAK-954 0.3 mg&#xD;
&#xD;
        -  TAK-954 1 mg&#xD;
&#xD;
        -  Placebo (dummy inactive solution) - this is a solution that looks like the study drug&#xD;
           but has no active ingredient.&#xD;
&#xD;
      This single center trial will be conducted in the United States. The duration of treatment is&#xD;
      3 days and the overall period of evaluation is up to 28 days. The participants will be&#xD;
      contacted by telephone (Days 10 to 14) for follow-up assessment. There will be another&#xD;
      follow-up phone call for women of childbearing potential (Days 38 to 43).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2018</start_date>
  <completion_date type="Actual">July 12, 2019</completion_date>
  <primary_completion_date type="Actual">June 7, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Change From Baseline in Half-emptying Time (T1/2) of Gastric Solids</measure>
    <time_frame>Predose and at multiple time-points post-dose (up to 9 hours) on Day 2</time_frame>
    <description>Half-emptying time (t1/2) of gastric solids is the time for half of the ingested solids or liquids to leave the stomach. Scintigraphy assessments were used to evaluate the gastric emptying of solids following a radio-labelled meal. A negative percent change from baseline indicated improvement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Colonic Geometric Center</measure>
    <time_frame>4, 24, and 48 hours post-radiolabeled meal on Day 2</time_frame>
    <description>The scintigraphic method was used to measure colonic geometric center following a radio-labelled meal. The geometric center (GC) was the weighted average of counts in the different colonic regions, where 0= no radioactivity in the colon and if radioactivity was detected in the colon, 1=all isotope was in the ascending colon and 5=all isotope was in the stool; a high GC indicated faster colonic transit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Colonic Filling at Hour 6</measure>
    <time_frame>6 hours post-radiolabel meal on Day 2</time_frame>
    <description>Colonic filling was estimated as percentage of the radio-labelled meal that reached the colon at Hour 6.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Half-emptying Time (T1/2) of Ascending Colon</measure>
    <time_frame>Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3</time_frame>
    <description>T1/2 of ascending colon emptying was estimated by analysis of proportionate emptying over time of counts from the colon. Scintigraphy assessments were used to evaluate the emptying of solids or liquids from ascending colon following a radio-labelled meal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCtau: Area Under the Plasma Concentration-Time Curve From Time 0 to t for TAK-954</measure>
    <time_frame>Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax: Maximum Observed Plasma Concentration for TAK-954</measure>
    <time_frame>Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ctrough: Observed Plasma Concentration at the End of a Dosing Interval</measure>
    <time_frame>At multiple time-points post-dose, up to 9 hours on Day 2 and up to 25 hours on Day 3</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Diabetic Gastroparesis</condition>
  <condition>Idiopathic Gastroparesis</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>TAK-954 placebo-matching, 60-minute infusion, intravenously (IV), once daily on Days 1 to 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAK-954 0.1 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAK-954 0.3 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-954 1 mg, 60-minute infusion, IV, once daily for up to 3 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAK-954 1 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAK-954</intervention_name>
    <description>TAK-954 IV infusion.</description>
    <arm_group_label>TAK-954 0.1 mg</arm_group_label>
    <arm_group_label>TAK-954 0.3 mg</arm_group_label>
    <arm_group_label>TAK-954 1 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>TAK-954 placebo-matching IV infusion.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Has diabetes mellitus with symptoms of gastroparesis and previously documented gastric&#xD;
             emptying delay or previously documented idiopathic gastroparesis in the last 5 years.&#xD;
&#xD;
          2. Has a body mass index (BMI) greater than or equal to (&gt;=) 16 and less than or equal to&#xD;
             (&lt;=) 40 kilogram per square meter (kg/m^2) at the Screening Visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has glycosylated hemoglobin (HbA1c) greater than (&gt;) 12 percent (%).&#xD;
&#xD;
          2. Has other structural diseases/conditions that affect the gastrointestinal (GI) system.&#xD;
&#xD;
          3. Are unable to withdraw drugs known to alter GI transit 48 hours prior to the study.&#xD;
&#xD;
          4. Has clinically significant abnormal baseline safety laboratory values.&#xD;
&#xD;
          5. Has preexisting hepatic disease that meets Child-Pugh Class B (moderate; total score 7&#xD;
             to 9 points) or C (severe; total score 10 to 15 points).&#xD;
&#xD;
          6. Are without known preexisting hepatic disease who have 1 or more of the following:&#xD;
&#xD;
               -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) &gt;2 times the&#xD;
                  upper limit of normal (ULN).&#xD;
&#xD;
               -  Bilirubin &gt;1.5 times the ULN unless due to Gilbert's syndrome.&#xD;
&#xD;
               -  International normalized ratio (INR) &gt;1.5 unless on anticoagulation therapy.&#xD;
&#xD;
          7. Has QT intervals with Fridericia correction method (QTcF) interval (&gt;=) 460&#xD;
             millisecond (msec) or with other factors that increase the risk of QT prolongation or&#xD;
             arrhythmic events at screening. Note: Participants with bundle branch block and a&#xD;
             prolonged QTc interval, or with QTcF between 450 and 460 msec, should be reviewed by&#xD;
             the Medical Monitor for potential inclusion.&#xD;
&#xD;
          8. Has second or third degree atrioventricular (AV) block; AV disassociation; &gt;5 beats of&#xD;
             non-sustained VT at a rate &gt;120 beats per minute (bpm); Electrocardiogram (ECG)&#xD;
             changes consistent with acute myocardial ischemia or infarction.&#xD;
&#xD;
          9. Has cardiac history that includes conditions requiring heart rate control (example,&#xD;
             atrial fibrillation, atrial flutter, ventricular tachycardia, or other&#xD;
             tachyarrhythmias).&#xD;
&#xD;
         10. Has clinical evidence (including physical examination, ECG, clinical laboratory value&#xD;
             and review of the medical history) of significant cardiovascular, respiratory,&#xD;
             moderate or severe renal insufficiency (creatinine clearance &lt;=60 mL/min),&#xD;
             hematological, neurological, or psychiatric disease, or other disease that interferes&#xD;
             with the objectives of the study.&#xD;
&#xD;
         11. If female, are pregnant or lactating or intending to become pregnant before&#xD;
             participating in this study, during the study, and 4 to 5 days (5 half-lives) PLUS 30&#xD;
             days after last dose of the study drug; or intending to donate ova during such time&#xD;
             period.&#xD;
&#xD;
         12. Are considered by the investigator to be alcoholics not in remission or known&#xD;
             substance abusers. Have a history of alcohol consumption exceeding 2 standard drinks&#xD;
             per day on average (1 glass is approximately equivalent to: beer [354 milliliter per&#xD;
             [mL/] 12 ounces], wine [118 mL/4 ounces], or distilled spirits [29.5 mL/1 ounce] per&#xD;
             day).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director Clinical Science</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <results_first_submitted>May 28, 2020</results_first_submitted>
  <results_first_submitted_qc>July 13, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 15, 2020</results_first_posted>
  <last_update_submitted>December 16, 2020</last_update_submitted>
  <last_update_submitted_qc>December 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroparesis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_access_criteria>IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/takeda/</ipd_url>
  </patient_data>
  <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>December 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT03281577/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>September 25, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT03281577/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 1 investigative site in the United States from 02 January 2018 to 12 July 2019.</recruitment_details>
      <pre_assignment_details>Participants with a diagnosis of diabetic or idiopathic gastroparesis were enrolled and randomized in 1:1:1:1 ratio to receive TAK-954 0.1 mg, 0.3 mg, 1 mg or placebo.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>TAK-954 placebo-matching, 60-minute infusion, intravenously (IV), once daily on Days 1 to 3.</description>
        </group>
        <group group_id="P2">
          <title>TAK-954 0.1 mg</title>
          <description>TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
        </group>
        <group group_id="P3">
          <title>TAK-954 0.3 mg</title>
          <description>TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
        </group>
        <group group_id="P4">
          <title>TAK-954 1 mg</title>
          <description>TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</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="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="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety analysis set included all subjects who receive at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>TAK-954 placebo-matching, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
        </group>
        <group group_id="B2">
          <title>TAK-954 0.1 mg</title>
          <description>TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
        </group>
        <group group_id="B3">
          <title>TAK-954 0.3 mg</title>
          <description>TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
        </group>
        <group group_id="B4">
          <title>TAK-954 1 mg</title>
          <description>TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
        </group>
        <group group_id="B5">
          <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="10"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="9"/>
            <count group_id="B4" value="7"/>
            <count group_id="B5" value="36"/>
          </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="46.2" spread="15.67"/>
                    <measurement group_id="B2" value="46.8" spread="12.45"/>
                    <measurement group_id="B3" value="42.3" spread="11.82"/>
                    <measurement group_id="B4" value="40.3" spread="8.75"/>
                    <measurement group_id="B5" value="44.3" spread="12.45"/>
                  </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="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="6"/>
                  </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="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_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Disease History</title>
          <description>Participants were categorized based on whether they have idiopathic gastroparesis or diabetic gastroparesis.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Idiopathic Gastroparesis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Diabetic Gastroparesis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.3" spread="15.05"/>
                    <measurement group_id="B2" value="73.4" spread="14.57"/>
                    <measurement group_id="B3" value="76.5" spread="17.97"/>
                    <measurement group_id="B4" value="62.5" spread="9.22"/>
                    <measurement group_id="B5" value="70.6" spread="15.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="166.2" spread="9.37"/>
                    <measurement group_id="B2" value="160.7" spread="7.27"/>
                    <measurement group_id="B3" value="165.7" spread="5.92"/>
                    <measurement group_id="B4" value="166.3" spread="7.57"/>
                    <measurement group_id="B5" value="164.6" spread="7.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <description>BMI=weight (kg)/height (m)^2</description>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.8" spread="4.88"/>
                    <measurement group_id="B2" value="28.4" spread="5.50"/>
                    <measurement group_id="B3" value="27.7" spread="5.44"/>
                    <measurement group_id="B4" value="22.6" spread="3.15"/>
                    <measurement group_id="B5" value="26.1" spread="5.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Half-emptying Time (T1/2) of Gastric Solids</title>
        <description>Half-emptying time (t1/2) of gastric solids is the time for half of the ingested solids or liquids to leave the stomach. Scintigraphy assessments were used to evaluate the gastric emptying of solids following a radio-labelled meal. A negative percent change from baseline indicated improvement.</description>
        <time_frame>Predose and at multiple time-points post-dose (up to 9 hours) on Day 2</time_frame>
        <population>Full analysis set included all randomized participants who received at least 1 dose of study drug. Overall number of participants analyzed is number of participants with data available for analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>TAK-954 placebo-matching, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
          </group>
          <group group_id="O2">
            <title>TAK-954 0.1 mg</title>
            <description>TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
          </group>
          <group group_id="O3">
            <title>TAK-954 0.3 mg</title>
            <description>TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
          </group>
          <group group_id="O4">
            <title>TAK-954 1 mg</title>
            <description>TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Half-emptying Time (T1/2) of Gastric Solids</title>
          <description>Half-emptying time (t1/2) of gastric solids is the time for half of the ingested solids or liquids to leave the stomach. Scintigraphy assessments were used to evaluate the gastric emptying of solids following a radio-labelled meal. A negative percent change from baseline indicated improvement.</description>
          <population>Full analysis set included all randomized participants who received at least 1 dose of study drug. Overall number of participants analyzed is number of participants with data available for analyses.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="23.71"/>
                    <measurement group_id="O2" value="-19.8" spread="14.43"/>
                    <measurement group_id="O3" value="-25.4" spread="20.90"/>
                    <measurement group_id="O4" value="-25.7" spread="23.56"/>
                  </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>0.0012</p_value>
            <p_value_desc>Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% confidence interval (CI) are presented.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Differences</param_type>
            <param_value>-25.81</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-41.757</ci_lower_limit>
            <ci_upper_limit>-9.858</ci_upper_limit>
            <estimate_desc>Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as covariate.</estimate_desc>
          </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>0.0018</p_value>
            <p_value_desc>Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Differences</param_type>
            <param_value>-27.52</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-45.224</ci_lower_limit>
            <ci_upper_limit>-9.813</ci_upper_limit>
            <estimate_desc>Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate.</estimate_desc>
          </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>&lt;.0001</p_value>
            <p_value_desc>Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Differences</param_type>
            <param_value>-41.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-59.616</ci_lower_limit>
            <ci_upper_limit>-23.902</ci_upper_limit>
            <estimate_desc>Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Colonic Geometric Center</title>
        <description>The scintigraphic method was used to measure colonic geometric center following a radio-labelled meal. The geometric center (GC) was the weighted average of counts in the different colonic regions, where 0= no radioactivity in the colon and if radioactivity was detected in the colon, 1=all isotope was in the ascending colon and 5=all isotope was in the stool; a high GC indicated faster colonic transit.</description>
        <time_frame>4, 24, and 48 hours post-radiolabeled meal on Day 2</time_frame>
        <population>Full analysis set included all randomized participants who received at least 1 dose of study drug. Number analyzed is the number of participants with evaluable data at the given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>TAK-954 placebo-matching, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
          </group>
          <group group_id="O2">
            <title>TAK-954 0.1 mg</title>
            <description>TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
          </group>
          <group group_id="O3">
            <title>TAK-954 0.3 mg</title>
            <description>TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
          </group>
          <group group_id="O4">
            <title>TAK-954 1 mg</title>
            <description>TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Colonic Geometric Center</title>
          <description>The scintigraphic method was used to measure colonic geometric center following a radio-labelled meal. The geometric center (GC) was the weighted average of counts in the different colonic regions, where 0= no radioactivity in the colon and if radioactivity was detected in the colon, 1=all isotope was in the ascending colon and 5=all isotope was in the stool; a high GC indicated faster colonic transit.</description>
          <population>Full analysis set included all randomized participants who received at least 1 dose of study drug. Number analyzed is the number of participants with evaluable data at the given time point.</population>
          <units>score 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="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Colonic Transit at 4 Hours, Day 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.539" spread="0.6809"/>
                    <measurement group_id="O2" value="1.190" spread="0.9083"/>
                    <measurement group_id="O3" value="1.737" spread="1.0302"/>
                    <measurement group_id="O4" value="1.148" spread="0.4138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Colonic Transit at 24 Hours, Day 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.965" spread="1.2964"/>
                    <measurement group_id="O2" value="3.792" spread="1.1441"/>
                    <measurement group_id="O3" value="3.468" spread="1.3252"/>
                    <measurement group_id="O4" value="2.978" spread="1.1382"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Colonic Transit at 48 Hours, Day 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.323" spread="1.2948"/>
                    <measurement group_id="O2" value="4.406" spread="1.1169"/>
                    <measurement group_id="O3" value="4.550" spread="0.9004"/>
                    <measurement group_id="O4" value="3.792" spread="1.0382"/>
                  </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>
            <groups_desc>Colonic Transit at 4 Hours, Day 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2590</p_value>
            <p_value_desc>Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Differences</param_type>
            <param_value>0.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.364</ci_lower_limit>
            <ci_upper_limit>1.795</ci_upper_limit>
            <estimate_desc>Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Colonic Transit at 4 Hours, Day 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0280</p_value>
            <p_value_desc>Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Differences</param_type>
            <param_value>1.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.119</ci_lower_limit>
            <ci_upper_limit>2.418</ci_upper_limit>
            <estimate_desc>Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Colonic Transit at 4 Hours, Day 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6882</p_value>
            <p_value_desc>Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Differences</param_type>
            <param_value>0.45</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.757</ci_lower_limit>
            <ci_upper_limit>1.660</ci_upper_limit>
            <estimate_desc>Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Colonic Transit at 24 Hours, Day 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0062</p_value>
            <p_value_desc>Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Differences</param_type>
            <param_value>1.87</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.493</ci_lower_limit>
            <ci_upper_limit>3.250</ci_upper_limit>
            <estimate_desc>Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Colonic Transit at 24 Hours, Day 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1490</p_value>
            <p_value_desc>Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Differences</param_type>
            <param_value>1.19</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.327</ci_lower_limit>
            <ci_upper_limit>2.717</ci_upper_limit>
            <estimate_desc>Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Colonic Transit at 24 Hours, Day 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6285</p_value>
            <p_value_desc>Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Differences</param_type>
            <param_value>0.63</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.931</ci_lower_limit>
            <ci_upper_limit>2.200</ci_upper_limit>
            <estimate_desc>Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Colonic Transit at 48 Hours, Day 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0358</p_value>
            <p_value_desc>Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Differences</param_type>
            <param_value>1.29</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.073</ci_lower_limit>
            <ci_upper_limit>2.501</ci_upper_limit>
            <estimate_desc>Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Colonic Transit at 48 Hours, Day 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0430</p_value>
            <p_value_desc>Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Differences</param_type>
            <param_value>1.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.035</ci_lower_limit>
            <ci_upper_limit>2.621</ci_upper_limit>
            <estimate_desc>Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Colonic Transit at 48 Hours, Day 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9419</p_value>
            <p_value_desc>Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Differences</param_type>
            <param_value>0.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.107</ci_lower_limit>
            <ci_upper_limit>1.611</ci_upper_limit>
            <estimate_desc>Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Colonic Filling at Hour 6</title>
        <description>Colonic filling was estimated as percentage of the radio-labelled meal that reached the colon at Hour 6.</description>
        <time_frame>6 hours post-radiolabel meal on Day 2</time_frame>
        <population>Full analysis set included all randomized participants who received at least 1 dose of study drug. Overall number of participants analyzed is number of participants with data available for analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>TAK-954 placebo-matching, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
          </group>
          <group group_id="O2">
            <title>TAK-954 0.1 mg</title>
            <description>TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
          </group>
          <group group_id="O3">
            <title>TAK-954 0.3 mg</title>
            <description>TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
          </group>
          <group group_id="O4">
            <title>TAK-954 1 mg</title>
            <description>TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Colonic Filling at Hour 6</title>
          <description>Colonic filling was estimated as percentage of the radio-labelled meal that reached the colon at Hour 6.</description>
          <population>Full analysis set included all randomized participants who received at least 1 dose of study drug. Overall number of participants analyzed is number of participants with data available for analyses.</population>
          <units>percentage of radio-labelled food</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.3" spread="25.38"/>
                    <measurement group_id="O2" value="55.6" spread="31.31"/>
                    <measurement group_id="O3" value="86.4" spread="19.76"/>
                    <measurement group_id="O4" value="75.3" spread="31.70"/>
                  </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>0.0436</p_value>
            <p_value_desc>Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Differences</param_type>
            <param_value>33.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.799</ci_lower_limit>
            <ci_upper_limit>65.439</ci_upper_limit>
            <estimate_desc>Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate.</estimate_desc>
          </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>0.0007</p_value>
            <p_value_desc>Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Differences</param_type>
            <param_value>57.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>23.555</ci_lower_limit>
            <ci_upper_limit>92.396</ci_upper_limit>
            <estimate_desc>Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate.</estimate_desc>
          </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>0.0134</p_value>
            <p_value_desc>Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Differences</param_type>
            <param_value>44.44</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.249</ci_lower_limit>
            <ci_upper_limit>80.629</ci_upper_limit>
            <estimate_desc>Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Half-emptying Time (T1/2) of Ascending Colon</title>
        <description>T1/2 of ascending colon emptying was estimated by analysis of proportionate emptying over time of counts from the colon. Scintigraphy assessments were used to evaluate the emptying of solids or liquids from ascending colon following a radio-labelled meal.</description>
        <time_frame>Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3</time_frame>
        <population>Full analysis set included all randomized participants who received at least 1 dose of study drug. Overall number of participants analyzed is the number of participants with data available for analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>TAK-954 placebo-matching, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
          </group>
          <group group_id="O2">
            <title>TAK-954 0.1 mg</title>
            <description>TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
          </group>
          <group group_id="O3">
            <title>TAK-954 0.3 mg</title>
            <description>TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
          </group>
          <group group_id="O4">
            <title>TAK-954 1 mg</title>
            <description>TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Half-emptying Time (T1/2) of Ascending Colon</title>
          <description>T1/2 of ascending colon emptying was estimated by analysis of proportionate emptying over time of counts from the colon. Scintigraphy assessments were used to evaluate the emptying of solids or liquids from ascending colon following a radio-labelled meal.</description>
          <population>Full analysis set included all randomized participants who received at least 1 dose of study drug. Overall number of participants analyzed is the number of participants with data available for analyses.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.1" lower_limit="2.6" upper_limit="36.0"/>
                    <measurement group_id="O2" value="5.4" lower_limit="1.9" upper_limit="28.8"/>
                    <measurement group_id="O3" value="6.3" lower_limit="0.6" upper_limit="11.0"/>
                    <measurement group_id="O4" value="7.4" lower_limit="0.9" upper_limit="13.6"/>
                  </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_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0789</p_value>
            <p_value_desc>Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Differences</param_type>
            <param_value>-10.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-21.507</ci_lower_limit>
            <ci_upper_limit>0.960</ci_upper_limit>
            <estimate_desc>Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate.</estimate_desc>
          </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>0.0270</p_value>
            <p_value_desc>Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Differences</param_type>
            <param_value>-13.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-25.242</ci_lower_limit>
            <ci_upper_limit>-1.314</ci_upper_limit>
            <estimate_desc>Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate.</estimate_desc>
          </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>0.0750</p_value>
            <p_value_desc>Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Differences</param_type>
            <param_value>-11.63</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-24.206</ci_lower_limit>
            <ci_upper_limit>0.952</ci_upper_limit>
            <estimate_desc>Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUCtau: Area Under the Plasma Concentration-Time Curve From Time 0 to t for TAK-954</title>
        <time_frame>Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3</time_frame>
        <population>Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of study drug and had sufficient blood sampling to allow for PK evaluation. Number analyzed is the number of participants with evaluable data at the given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>TAK-954 0.1 mg</title>
            <description>TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
          </group>
          <group group_id="O2">
            <title>TAK-954 0.3 mg</title>
            <description>TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
          </group>
          <group group_id="O3">
            <title>TAK-954 1 mg</title>
            <description>TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
          </group>
        </group_list>
        <measure>
          <title>AUCtau: Area Under the Plasma Concentration-Time Curve From Time 0 to t for TAK-954</title>
          <population>Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of study drug and had sufficient blood sampling to allow for PK evaluation. Number analyzed is the number of participants with evaluable data at the given time point.</population>
          <units>h*ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.99" spread="2.110"/>
                    <measurement group_id="O2" value="25.79" spread="8.340"/>
                    <measurement group_id="O3" value="83.75" spread="25.453"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.16" spread="3.033"/>
                    <measurement group_id="O2" value="33.94" spread="9.249"/>
                    <measurement group_id="O3" value="109.86" spread="31.009"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.72" spread="3.387"/>
                    <measurement group_id="O2" value="39.34" spread="12.699"/>
                    <measurement group_id="O3" value="125.88" spread="34.586"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cmax: Maximum Observed Plasma Concentration for TAK-954</title>
        <time_frame>Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3</time_frame>
        <population>PK analysis set included all participants who received at least 1 dose of study drug and had sufficient blood sampling to allow for PK evaluation. Number analyzed is the number of participants with evaluable data at the given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>TAK-954 0.1 mg</title>
            <description>TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
          </group>
          <group group_id="O2">
            <title>TAK-954 0.3 mg</title>
            <description>TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
          </group>
          <group group_id="O3">
            <title>TAK-954 1 mg</title>
            <description>TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax: Maximum Observed Plasma Concentration for TAK-954</title>
          <population>PK analysis set included all participants who received at least 1 dose of study drug and had sufficient blood sampling to allow for PK evaluation. Number analyzed is the number of participants with evaluable data at the given time point.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.637" spread="0.3918"/>
                    <measurement group_id="O2" value="5.346" spread="1.5797"/>
                    <measurement group_id="O3" value="16.029" spread="2.9239"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.687" spread="0.4227"/>
                    <measurement group_id="O2" value="5.821" spread="1.9447"/>
                    <measurement group_id="O3" value="15.517" spread="3.7070"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.705" spread="0.3297"/>
                    <measurement group_id="O2" value="5.056" spread="1.5430"/>
                    <measurement group_id="O3" value="17.700" spread="7.1544"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ctrough: Observed Plasma Concentration at the End of a Dosing Interval</title>
        <time_frame>At multiple time-points post-dose, up to 9 hours on Day 2 and up to 25 hours on Day 3</time_frame>
        <population>PK analysis set included all participants who received at least 1 dose of study drug and had sufficient blood sampling to allow for PK evaluation. Number analyzed is the number of participants with evaluable data at the given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>TAK-954 0.1 mg</title>
            <description>TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
          </group>
          <group group_id="O2">
            <title>TAK-954 0.3 mg</title>
            <description>TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
          </group>
          <group group_id="O3">
            <title>TAK-954 1 mg</title>
            <description>TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Ctrough: Observed Plasma Concentration at the End of a Dosing Interval</title>
          <population>PK analysis set included all participants who received at least 1 dose of study drug and had sufficient blood sampling to allow for PK evaluation. Number analyzed is the number of participants with evaluable data at the given time point.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1969" spread="0.05406"/>
                    <measurement group_id="O2" value="0.4364" spread="0.20371"/>
                    <measurement group_id="O3" value="1.6817" spread="0.47072"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2854" spread="0.10319"/>
                    <measurement group_id="O2" value="0.6392" spread="0.26371"/>
                    <measurement group_id="O3" value="2.2620" spread="0.40493"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose up to 30 days post last dose (Up to 46 days)</time_frame>
      <desc>At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>TAK-954 placebo-matching, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
        </group>
        <group group_id="E2">
          <title>TAK-954 0.1 mg</title>
          <description>TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
        </group>
        <group group_id="E3">
          <title>TAK-954 0.3 mg</title>
          <description>TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
        </group>
        <group group_id="E4">
          <title>TAK-954 1 mg</title>
          <description>TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 22.0</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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Pancreatic enzymes increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 22.0</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="6" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Sensation of foreign body</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Infusion site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Drug withdrawal syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="7"/>
              </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="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Cold sweat</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="7"/>
              </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>The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi-site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Director</name_or_title>
      <organization>Takeda</organization>
      <phone>+1-877-825-3327</phone>
      <email>takedadisclosures@takeda.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/NCT03281577
org study id: TAK-954-2003
secondary id: U1111-1200-9396
nct id: NCT03281577
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the dose-dependent effects of TAK-954 on gastric
      emptying time of solids in participants with diabetic or idiopathic gastroparesis assessed by
      scintigraphy.
The drug being tested in this study is called TAK-954. TAK-954 is a serotonin (5 HT4)
      receptor agonist and is being tested to treat people who have diabetic or idiopathic
      gastroparesis and who previously reported delay in stomach emptying. This study will look at
      the gastric emptying time of solids in people who take TAK-954 or placebo.

      The study will enroll approximately 41 patients. Participants will be randomly assigned (by
      chance, like flipping a coin) to one of the four treatment groups-which will remain
      undisclosed to the participant and study doctor during the study (unless there is an urgent
      medical need):

        -  TAK-954 0.1 mg

        -  TAK-954 0.3 mg

        -  TAK-954 1 mg

        -  Placebo (dummy inactive solution) - this is a solution that looks like the study drug
           but has no active ingredient.

      This single center trial will be conducted in the United States. The duration of treatment is
      3 days and the overall period of evaluation is up to 28 days. The participants will be
      contacted by telephone (Days 10 to 14) for follow-up assessment. There will be another
      follow-up phone call for women of childbearing potential (Days 38 to 43).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percent Change From Baseline in Half-emptying Time (T1/2) of Gastric Solids
time frame: Predose and at multiple time-points post-dose (up to 9 hours) on Day 2
description: Half-emptying time (t1/2) of gastric solids is the time for half of the ingested solids or liquids to leave the stomach. Scintigraphy assessments were used to evaluate the gastric emptying of solids following a radio-labelled meal. A negative percent change from baseline indicated improvement.
measure: Colonic Geometric Center
time frame: 4, 24, and 48 hours post-radiolabeled meal on Day 2
description: The scintigraphic method was used to measure colonic geometric center following a radio-labelled meal. The geometric center (GC) was the weighted average of counts in the different colonic regions, where 0= no radioactivity in the colon and if radioactivity was detected in the colon, 1=all isotope was in the ascending colon and 5=all isotope was in the stool; a high GC indicated faster colonic transit.
measure: Colonic Filling at Hour 6
time frame: 6 hours post-radiolabel meal on Day 2
description: Colonic filling was estimated as percentage of the radio-labelled meal that reached the colon at Hour 6.
measure: Half-emptying Time (T1/2) of Ascending Colon
time frame: Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3
description: T1/2 of ascending colon emptying was estimated by analysis of proportionate emptying over time of counts from the colon. Scintigraphy assessments were used to evaluate the emptying of solids or liquids from ascending colon following a radio-labelled meal.
measure: AUCtau: Area Under the Plasma Concentration-Time Curve From Time 0 to t for TAK-954
time frame: Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3
measure: Cmax: Maximum Observed Plasma Concentration for TAK-954
time frame: Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3
measure: Ctrough: Observed Plasma Concentration at the End of a Dosing Interval
time frame: At multiple time-points post-dose, up to 9 hours on Day 2 and up to 25 hours on Day 3
arm group label: Placebo
arm group type: Placebo Comparator
description: TAK-954 placebo-matching, 60-minute infusion, intravenously (IV), once daily on Days 1 to 3.
arm group label: TAK-954 0.1 mg
arm group type: Experimental
description: TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
arm group label: TAK-954 0.3 mg
arm group type: Experimental
description: TAK-954 1 mg, 60-minute infusion, IV, once daily for up to 3 days.
arm group label: TAK-954 1 mg
arm group type: Experimental
description: TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
intervention type: Drug
intervention name: TAK-954
description: TAK-954 IV infusion.
arm group label: TAK-954 0.1 mg
arm group label: TAK-954 0.3 mg
arm group label: TAK-954 1 mg
intervention type: Drug
intervention name: Placebo
description: TAK-954 placebo-matching IV infusion.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Medical Director Clinical Science
role: Study Director
affiliation: Takeda
facility: 
country: United States
responsible party type: Sponsor
mesh term: Gastroparesis
sharing ipd: Yes
ipd description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
ipd url: https://vivli.org/ourmember/takeda/
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 