<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/NCT01660243</url>
  </required_header>
  <id_info>
    <org_study_id>MT-9938-A01</org_study_id>
    <nct_id>NCT01660243</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of MT-9938 for Treatment of Uremic Pruritus in Subjects With End-stage Renal Disease Receiving Hemodialysis</brief_title>
  <official_title>A Phase 2, Randomized, Double-blind, Placebo-controlled, Fixed-dose, Parallel-group, Multicenter, Efficacy, and Safety Study of MT-9938 for Treatment of Uremic Pruritus in Subjects With End-stage Renal Disease Receiving Hemodialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Toray Industries, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Toray Industries, Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being conducted to investigate the efficacy of MT-9938 compared with placebo&#xD;
      after 2 weeks, to continue to evaluate efficacy for an additional 6 weeks, and to explore the&#xD;
      effect of a reduction in itching intensity on health-related Quality of Life(QoL) domains,&#xD;
      especially those which recent research suggests have a positive correlation with overall&#xD;
      survival for this patient group. The study will consist of the following phases: Screening (1&#xD;
      to 2 weeks), Run in (1 week), double-blind Treatment (8 weeks), Washout (1 week) culminating&#xD;
      in a Follow-up Visit (1 week after the last dose).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study has been terminated because of insufficient patient recruitment. There were no&#xD;
      safety concerns.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    This study has been terminated because of insufficient patient recruitment.&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Worst-itching 11-point Numerical Rating Scale (NRS)</measure>
    <time_frame>2 weeks, 4 weeks and 8 week</time_frame>
    <description>The subject indicated the number on the line from left (0:no itching) to right (10:worst itch I have ever experienced). Assessments was made twice daily using an electronic Patient Reported Outcomes (ePRO) device from the Screening Visit to the Follow-up Visit (Week 9). The 2 daily assessments was separated by 12 h, at approximately 8 am and at approximately 8 pm. Subjects selected the number that best described the worst itch during the day (assessed at approximately 8 pm) or during the night (assessed at approximately 8 am). The day or night score, whichever was greater, was used to calculate the weekly average score and changes from baseline (average over the Run-in Phase [Days -7 to -1]) score in weekly average at 2, 4 and 8 weeks as specified in the protocol are reported. Amount of change score of plus indicates worsening, and minus indicates improvement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Worst-itching Visual Analog Scale (VAS)</measure>
    <time_frame>2 weeks, 4 weeks and 8 weeks</time_frame>
    <description>The subject placed a single vertical mark on the line of a VAS corresponding to degree of itching intensity from left (no itching) to right (worst itch I have ever experienced). The VAS represents a 100 mm line. It consists of 101 selectable regions and the subject's score on the VAS will correspond to the region (0 to 100) selected on the line. Assessments was made twice daily using an ePRO device from the Screening Visit to the Follow-up Visit (Week 9). The 2 daily assessments was separated by 12 h, in the morning at approximately 8 am and in the night at approximately 8 pm. Subjects put a single vertical mark on the line to show the intensity of your worst itching during the day or during the night. The day or night score, whichever was greater, was used to calculate the weekly average score and changes from baseline in weekly average at 2, 4 and 8 weeks as specified in the protocol are reported. Amount of change score of plus indicates worsening, and minus indicates improvement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Itch Severity Score</measure>
    <time_frame>2 weeks, 4 weeks and 8 weeks</time_frame>
    <description>The subject performed an assessment on day and nighttime symptoms of itch and effect of itch on sleep using a 5-point ordinal scale of itchiness (0 = none, 1 = mild, 2 = Moderate, 3=Severe, 4 = very severe). Assessments was made during each dialysis treatment (3x/week) and recorded on paper from the Screening Visit to the Follow-up Visit (Week 9). Change from Baseline (average over the Run-in Phase [Days -7 to -1]) in Weekly Averages of Itch Severity Score were assessed and score at 2, 4 and 8 weeks as specified in the protocol are reported. Amount of change score of plus indicates worsening, and minus indicates improvement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Sleep Quality Assessment</measure>
    <time_frame>2 weeks, 4 weeks and 8 weeks</time_frame>
    <description>The PSQI has a minimum possible score of 0 (better sleep quality) and a maximum possible score of 10 (worse sleep quality). Subjects was asked to rate their sleep experience during the previous week. Pittsburgh Sleep Quality Index (PSQI) modified assessment was made during the dialysis treatment 1x/week every week and recorded on paper from the Screening Visit to the Follow-up Visit (Week 9).Change from Baseline (the Run-in Phase [Days -7 to -1]) were assessed and score at 2, 4 and 8 weeks as specified in the protocol are reported. Amount of change score of plus indicates worsening, and minus indicates improvement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in QoL Assessment (Skindex-10)</measure>
    <time_frame>2 weeks, 4 weeks and 8 weeks</time_frame>
    <description>The Skindex-10 has a minimum possible score of 0 (itching not bothersome) and a maximum possible score of 60 (itching very bothersome). The Skindex-10 is a self-administered questionnaire used to evaluate the health-related QoL in UP. It is comprised of 10 questions, adopted for pruritus from the Skindex-16, a widely used instrument for a variety of skin disease. Subjects was asked to identify on paper at Baseline and Weeks 2, 4, and 8 (EOT) what has bothered them most during the past week by marking along a scale 0 to 6 boxes from &quot;never bothered&quot; to &quot;always bothered. Change from Baseline (the Run-in Phase [Days -7 to -1]) were assessed. Amount of change score of plus indicates worsening, and minus indicates improvement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Mean Value in Treatment Satisfaction (Patient's Global Impression of Change )</measure>
    <time_frame>2 weeks, 4 weeks and 8 weeks</time_frame>
    <description>The PGIC has a minimum possible score of 1 (very much improved) and a maximum possible score of 7 (very much worse). Subjects was asked to use a categorical scale with 7 categories to describe their global impression of change (PGIC) with study drug treatment. Subjects recorded their impression of change on paper at Weeks 2, 4, and 8 (EOT).&#xD;
Although the change from baseline (run-in phase [Days -7 to -1]) was specified as an outcome in this study, it was not calculated because the target enrollment was not met and no meaningful statistical analysis could be expected. Therefore, the mean value of patients at each point is shown instead.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in QoL Assessment (5-D-Itch Scale)</measure>
    <time_frame>2 weeks, 4 weeks and 8 weeks</time_frame>
    <description>The 5-D-Itch scale has a minimum possible score of 5 (better) and a maximum possible score of 25 (worse). Subjects was asked to assess QoL by means of the 5D-Itch-Scale at Baseline, Weeks 2, 4, and 8 (EOT). The 5D-Itch Scale is a 5-item (duration, degree, direction, disability, and distribution) multidimensional measure of pruritus itch. Change from Baseline (the Run-in Phase [Days -7 to -1]) were assessed. Amount of change score of plus indicates worsening, and minus indicates improvement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Number of Patients in Excoriation</measure>
    <time_frame>2 weeks, 4 weeks and 8 weeks</time_frame>
    <description>Investigator and/or the designated medically qualified staff assessed the subject's excoriation at Baseline, and weekly thereafter, by completing the subject's answers to the following questions:&#xD;
Excoriation present? Yes/No If yes, please rate the severity: Mild/Moderate/Severe&#xD;
Although the change from baseline (run-in phase [Days -7 to -1]) was specified as an outcome in this study, it was not calculated because the target enrollment was not met and no meaningful statistical analysis could be expected. Therefore, the number of patients at each point is shown instead.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>8 weeks</time_frame>
    <description>The number of subjects with at least 1 treatment-emergent adverse event (TEAE). Please see the adverse event table for specific.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Uremic Pruritus</condition>
  <arm_group>
    <arm_group_label>MT-9938 2.5μg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>MT-9938 5μg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>MT-9938 10μg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nalfurafine hydrochloride(MT-9938) 2.5μg</intervention_name>
    <description>2.5 μg (2capsules) once daily for 8 weeks</description>
    <arm_group_label>MT-9938 2.5μg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nalfurafine hydrochloride(MT-9938) 5μg</intervention_name>
    <description>5 μg (2capsules) once daily for 8 weeks</description>
    <arm_group_label>MT-9938 5μg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nalfurafine hydrochloride(MT-9938) 10μg</intervention_name>
    <description>10 μg (2capsules) once daily for 8 weeks</description>
    <arm_group_label>MT-9938 10μg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo (2capsules) once daily for 8 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  On stable hemodialysis for at least 3 months&#xD;
&#xD;
          -  Has stable functioning arteriovenous fistula, graft or other venous access&#xD;
&#xD;
          -  Has continued (uncontrolled) uremic pruritus despite standard of care in the&#xD;
             institution&#xD;
&#xD;
          -  Has severe pruritus, as determined by a qualifying score of ≥3 on the Itch Severity&#xD;
             Score Scale (0 to 4) either day or night during the week prior to Screening Visit&#xD;
&#xD;
          -  Has no known drug addiction to any prescription, nonprescription, herbal or natural&#xD;
             drugs, and successfully passes a drug screen test&#xD;
&#xD;
          -  Women and men whose partners are of childbearing potential agree to practice the&#xD;
             medically acceptable methods of birth control and agree to continue with the regimen&#xD;
             throughout the duration of the study&#xD;
&#xD;
          -  Capable of understanding and responding to the subject questionnaires, understands the&#xD;
             purpose and risks of the study, and has given written informed consent&#xD;
&#xD;
          -  Has rated his/her NRS score each day for at least 5 days out of the 7 days of the&#xD;
             Run-in Phase&#xD;
&#xD;
          -  Has severe pruritus, as determined by qualifying mean worst NRS score in a day of ≥5&#xD;
             (on 11 point NRS) at the end of the 1-week Run-in Phase&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current, clinically significant medical comorbidities&#xD;
&#xD;
          -  Abnormal liver dysfunction&#xD;
&#xD;
          -  Pruritus attributed mainly to any disease unrelated to kidney disease&#xD;
&#xD;
          -  Calcium x phosphorus product &gt;80 mg2/dL2 or hemoglobin &lt;7 g/dL or parathyroid hormone&#xD;
             levels &gt;1000 pg/mL at Screening&#xD;
&#xD;
          -  Received ultraviolet B treatment within 30 days prior to Screening&#xD;
&#xD;
          -  Started or changed psychotropic medication within 14 days prior to Screening&#xD;
&#xD;
          -  Is receiving opioid antagonists or opioid agonists within 7 days prior to Screening&#xD;
             and not willing to abstain from these medications during the study.&#xD;
&#xD;
          -  Started or changed medications, creams or emollients including over-the-counter oil&#xD;
             bath treatment for relief of pruritus within 7 days prior to Screening&#xD;
&#xD;
          -  Has known hypersensitivity to opioids or the study drug ingredients&#xD;
&#xD;
          -  Is currently participating in an investigational drug or device clinical study or was&#xD;
             participating in such a study within 30 days prior to the start of Screening&#xD;
&#xD;
          -  Female subject who is known to be pregnant or nursing&#xD;
&#xD;
          -  Is considered not suitable for inclusion in the study in the opinion of Investigator&#xD;
&#xD;
          -  Has current suicidal ideation with some intent to act or with specific plan and intent&#xD;
             or had suicidal behavior at any time in subject's life&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rosedale</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>August 2, 2012</study_first_submitted>
  <study_first_submitted_qc>August 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2012</study_first_posted>
  <results_first_submitted>August 31, 2021</results_first_submitted>
  <results_first_submitted_qc>January 12, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 9, 2022</results_first_posted>
  <disposition_first_submitted>October 20, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>February 18, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">March 17, 2016</disposition_first_posted>
  <last_update_submitted>January 12, 2022</last_update_submitted>
  <last_update_submitted_qc>January 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pruritus</keyword>
  <keyword>Renal dialysis</keyword>
  <keyword>Receptors, Opioid, kappa</keyword>
  <keyword>Sleep Disorders</keyword>
  <keyword>Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Pruritus</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Subjects who remained eligible entered the 1-week Run-in Phase. The NRS, VAS, and Itch Severity Score were averaged and formed the Baseline itch-intensity scores.&#xD;
After the Run-in, subjects who met additional inclusion criteria (having an NRS score for at least 5 days out of the 7 days and a mean worst NRS score ≥5) entered the Double-blind Treatment Phase (8 weeks) and were randomized to 1 of 4 study treatments.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>MT-9938 2.5μg</title>
          <description>Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks</description>
        </group>
        <group group_id="P2">
          <title>MT-9938 5μg</title>
          <description>Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks</description>
        </group>
        <group group_id="P3">
          <title>MT-9938 10μg</title>
          <description>Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks</description>
        </group>
        <group group_id="P4">
          <title>Placebo</title>
          <description>Placebo: Placebo (2capsules) once daily for 8 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <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="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unable to visit clinic to obtain study drug due to hospitalization</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>
              <title>Subject was noncompliant with study drug after experiencing AEs; was not discontinued due to the AEs</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomization error</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_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>ITT</population>
      <group_list>
        <group group_id="B1">
          <title>MT-9938 2.5μg</title>
          <description>Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks</description>
        </group>
        <group group_id="B2">
          <title>MT-9938 5μg</title>
          <description>Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks</description>
        </group>
        <group group_id="B3">
          <title>MT-9938 10μg</title>
          <description>Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks</description>
        </group>
        <group group_id="B4">
          <title>Placebo</title>
          <description>Placebo: Placebo (2capsules) once daily for 8 weeks</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="13"/>
            <count group_id="B3" value="11"/>
            <count group_id="B4" value="11"/>
            <count group_id="B5" value="45"/>
          </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="58.5" spread="10.62"/>
                    <measurement group_id="B2" value="54.6" spread="12.78"/>
                    <measurement group_id="B3" value="55.3" spread="13.64"/>
                    <measurement group_id="B4" value="55.2" spread="12.94"/>
                    <measurement group_id="B5" value="55.8" spread="12.25"/>
                  </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="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Worst-itching 11-point Numerical Rating Scale (NRS)</title>
        <description>The subject indicated the number on the line from left (0:no itching) to right (10:worst itch I have ever experienced). Assessments was made twice daily using an electronic Patient Reported Outcomes (ePRO) device from the Screening Visit to the Follow-up Visit (Week 9). The 2 daily assessments was separated by 12 h, at approximately 8 am and at approximately 8 pm. Subjects selected the number that best described the worst itch during the day (assessed at approximately 8 pm) or during the night (assessed at approximately 8 am). The day or night score, whichever was greater, was used to calculate the weekly average score and changes from baseline (average over the Run-in Phase [Days -7 to -1]) score in weekly average at 2, 4 and 8 weeks as specified in the protocol are reported. Amount of change score of plus indicates worsening, and minus indicates improvement.</description>
        <time_frame>2 weeks, 4 weeks and 8 week</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>MT-9938 2.5μg</title>
            <description>Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>MT-9938 5μg</title>
            <description>Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks</description>
          </group>
          <group group_id="O3">
            <title>MT-9938 10μg</title>
            <description>Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo (2capsules) once daily for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Worst-itching 11-point Numerical Rating Scale (NRS)</title>
          <description>The subject indicated the number on the line from left (0:no itching) to right (10:worst itch I have ever experienced). Assessments was made twice daily using an electronic Patient Reported Outcomes (ePRO) device from the Screening Visit to the Follow-up Visit (Week 9). The 2 daily assessments was separated by 12 h, at approximately 8 am and at approximately 8 pm. Subjects selected the number that best described the worst itch during the day (assessed at approximately 8 pm) or during the night (assessed at approximately 8 am). The day or night score, whichever was greater, was used to calculate the weekly average score and changes from baseline (average over the Run-in Phase [Days -7 to -1]) score in weekly average at 2, 4 and 8 weeks as specified in the protocol are reported. Amount of change score of plus indicates worsening, and minus indicates improvement.</description>
          <population>ITT</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="13"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At 2 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.11" spread="1.224"/>
                    <measurement group_id="O2" value="-1.19" spread="1.177"/>
                    <measurement group_id="O3" value="-1.12" spread="0.828"/>
                    <measurement group_id="O4" value="-2.27" spread="2.774"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 4 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.41" spread="2.032"/>
                    <measurement group_id="O2" value="-2.12" spread="2.527"/>
                    <measurement group_id="O3" value="-1.85" spread="1.392"/>
                    <measurement group_id="O4" value="-2.25" spread="3.114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 8 weeks (EOT)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.33" spread="2.269"/>
                    <measurement group_id="O2" value="-3.13" spread="2.833"/>
                    <measurement group_id="O3" value="-3.42" spread="2.262"/>
                    <measurement group_id="O4" value="-3.39" spread="3.614"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Worst-itching Visual Analog Scale (VAS)</title>
        <description>The subject placed a single vertical mark on the line of a VAS corresponding to degree of itching intensity from left (no itching) to right (worst itch I have ever experienced). The VAS represents a 100 mm line. It consists of 101 selectable regions and the subject's score on the VAS will correspond to the region (0 to 100) selected on the line. Assessments was made twice daily using an ePRO device from the Screening Visit to the Follow-up Visit (Week 9). The 2 daily assessments was separated by 12 h, in the morning at approximately 8 am and in the night at approximately 8 pm. Subjects put a single vertical mark on the line to show the intensity of your worst itching during the day or during the night. The day or night score, whichever was greater, was used to calculate the weekly average score and changes from baseline in weekly average at 2, 4 and 8 weeks as specified in the protocol are reported. Amount of change score of plus indicates worsening, and minus indicates improvement.</description>
        <time_frame>2 weeks, 4 weeks and 8 weeks</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>MT-9938 2.5μg</title>
            <description>Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>MT-9938 5μg</title>
            <description>Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks</description>
          </group>
          <group group_id="O3">
            <title>MT-9938 10μg</title>
            <description>Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo (2capsules) once daily for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Worst-itching Visual Analog Scale (VAS)</title>
          <description>The subject placed a single vertical mark on the line of a VAS corresponding to degree of itching intensity from left (no itching) to right (worst itch I have ever experienced). The VAS represents a 100 mm line. It consists of 101 selectable regions and the subject's score on the VAS will correspond to the region (0 to 100) selected on the line. Assessments was made twice daily using an ePRO device from the Screening Visit to the Follow-up Visit (Week 9). The 2 daily assessments was separated by 12 h, in the morning at approximately 8 am and in the night at approximately 8 pm. Subjects put a single vertical mark on the line to show the intensity of your worst itching during the day or during the night. The day or night score, whichever was greater, was used to calculate the weekly average score and changes from baseline in weekly average at 2, 4 and 8 weeks as specified in the protocol are reported. Amount of change score of plus indicates worsening, and minus indicates improvement.</description>
          <population>ITT</population>
          <units>mm</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="13"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At 2 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.77" spread="15.158"/>
                    <measurement group_id="O2" value="-12.27" spread="12.154"/>
                    <measurement group_id="O3" value="-6.56" spread="18.778"/>
                    <measurement group_id="O4" value="-21.09" spread="26.719"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 4 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.17" spread="22.631"/>
                    <measurement group_id="O2" value="-19.46" spread="25.097"/>
                    <measurement group_id="O3" value="-21.24" spread="20.300"/>
                    <measurement group_id="O4" value="-23.63" spread="31.239"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 8 weeks (EOT)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.06" spread="23.686"/>
                    <measurement group_id="O2" value="-29.16" spread="27.628"/>
                    <measurement group_id="O3" value="-24.49" spread="42.732"/>
                    <measurement group_id="O4" value="-30.09" spread="31.582"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Itch Severity Score</title>
        <description>The subject performed an assessment on day and nighttime symptoms of itch and effect of itch on sleep using a 5-point ordinal scale of itchiness (0 = none, 1 = mild, 2 = Moderate, 3=Severe, 4 = very severe). Assessments was made during each dialysis treatment (3x/week) and recorded on paper from the Screening Visit to the Follow-up Visit (Week 9). Change from Baseline (average over the Run-in Phase [Days -7 to -1]) in Weekly Averages of Itch Severity Score were assessed and score at 2, 4 and 8 weeks as specified in the protocol are reported. Amount of change score of plus indicates worsening, and minus indicates improvement.</description>
        <time_frame>2 weeks, 4 weeks and 8 weeks</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>MT-9938 2.5μg</title>
            <description>Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>MT-9938 5μg</title>
            <description>Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks</description>
          </group>
          <group group_id="O3">
            <title>MT-9938 10μg</title>
            <description>Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo (2capsules) once daily for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Itch Severity Score</title>
          <description>The subject performed an assessment on day and nighttime symptoms of itch and effect of itch on sleep using a 5-point ordinal scale of itchiness (0 = none, 1 = mild, 2 = Moderate, 3=Severe, 4 = very severe). Assessments was made during each dialysis treatment (3x/week) and recorded on paper from the Screening Visit to the Follow-up Visit (Week 9). Change from Baseline (average over the Run-in Phase [Days -7 to -1]) in Weekly Averages of Itch Severity Score were assessed and score at 2, 4 and 8 weeks as specified in the protocol are reported. Amount of change score of plus indicates worsening, and minus indicates improvement.</description>
          <population>ITT</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="13"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At 2 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.77" spread="0.721"/>
                    <measurement group_id="O2" value="-0.77" spread="0.542"/>
                    <measurement group_id="O3" value="-0.43" spread="0.872"/>
                    <measurement group_id="O4" value="-0.92" spread="1.106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 4 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.81" spread="0.835"/>
                    <measurement group_id="O2" value="-1.08" spread="0.741"/>
                    <measurement group_id="O3" value="-1.30" spread="0.885"/>
                    <measurement group_id="O4" value="-0.90" spread="1.275"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 8 weeks (EOT)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.13" spread="1.003"/>
                    <measurement group_id="O2" value="-1.49" spread="0.919"/>
                    <measurement group_id="O3" value="-1.28" spread="1.094"/>
                    <measurement group_id="O4" value="-1.28" spread="1.197"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Sleep Quality Assessment</title>
        <description>The PSQI has a minimum possible score of 0 (better sleep quality) and a maximum possible score of 10 (worse sleep quality). Subjects was asked to rate their sleep experience during the previous week. Pittsburgh Sleep Quality Index (PSQI) modified assessment was made during the dialysis treatment 1x/week every week and recorded on paper from the Screening Visit to the Follow-up Visit (Week 9).Change from Baseline (the Run-in Phase [Days -7 to -1]) were assessed and score at 2, 4 and 8 weeks as specified in the protocol are reported. Amount of change score of plus indicates worsening, and minus indicates improvement.</description>
        <time_frame>2 weeks, 4 weeks and 8 weeks</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>MT-9938 2.5μg</title>
            <description>Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>MT-9938 5μg</title>
            <description>Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks</description>
          </group>
          <group group_id="O3">
            <title>MT-9938 10μg</title>
            <description>Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo (2capsules) once daily for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Sleep Quality Assessment</title>
          <description>The PSQI has a minimum possible score of 0 (better sleep quality) and a maximum possible score of 10 (worse sleep quality). Subjects was asked to rate their sleep experience during the previous week. Pittsburgh Sleep Quality Index (PSQI) modified assessment was made during the dialysis treatment 1x/week every week and recorded on paper from the Screening Visit to the Follow-up Visit (Week 9).Change from Baseline (the Run-in Phase [Days -7 to -1]) were assessed and score at 2, 4 and 8 weeks as specified in the protocol are reported. Amount of change score of plus indicates worsening, and minus indicates improvement.</description>
          <population>ITT</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="13"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At 2 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="1.06"/>
                    <measurement group_id="O2" value="-0.2" spread="2.17"/>
                    <measurement group_id="O3" value="-0.2" spread="1.64"/>
                    <measurement group_id="O4" value="-1.0" spread="1.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 4 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="1.92"/>
                    <measurement group_id="O2" value="-0.3" spread="1.65"/>
                    <measurement group_id="O3" value="-1.1" spread="1.36"/>
                    <measurement group_id="O4" value="-0.1" spread="1.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 8 weeks (EOT)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" spread="1.35"/>
                    <measurement group_id="O2" value="-0.6" spread="1.62"/>
                    <measurement group_id="O3" value="-1.2" spread="1.55"/>
                    <measurement group_id="O4" value="-0.4" spread="1.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in QoL Assessment (Skindex-10)</title>
        <description>The Skindex-10 has a minimum possible score of 0 (itching not bothersome) and a maximum possible score of 60 (itching very bothersome). The Skindex-10 is a self-administered questionnaire used to evaluate the health-related QoL in UP. It is comprised of 10 questions, adopted for pruritus from the Skindex-16, a widely used instrument for a variety of skin disease. Subjects was asked to identify on paper at Baseline and Weeks 2, 4, and 8 (EOT) what has bothered them most during the past week by marking along a scale 0 to 6 boxes from &quot;never bothered&quot; to &quot;always bothered. Change from Baseline (the Run-in Phase [Days -7 to -1]) were assessed. Amount of change score of plus indicates worsening, and minus indicates improvement.</description>
        <time_frame>2 weeks, 4 weeks and 8 weeks</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>MT-9938 2.5μg</title>
            <description>Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>MT-9938 5μg</title>
            <description>Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks</description>
          </group>
          <group group_id="O3">
            <title>MT-9938 10μg</title>
            <description>Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo (2capsules) once daily for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in QoL Assessment (Skindex-10)</title>
          <description>The Skindex-10 has a minimum possible score of 0 (itching not bothersome) and a maximum possible score of 60 (itching very bothersome). The Skindex-10 is a self-administered questionnaire used to evaluate the health-related QoL in UP. It is comprised of 10 questions, adopted for pruritus from the Skindex-16, a widely used instrument for a variety of skin disease. Subjects was asked to identify on paper at Baseline and Weeks 2, 4, and 8 (EOT) what has bothered them most during the past week by marking along a scale 0 to 6 boxes from &quot;never bothered&quot; to &quot;always bothered. Change from Baseline (the Run-in Phase [Days -7 to -1]) were assessed. Amount of change score of plus indicates worsening, and minus indicates improvement.</description>
          <population>ITT</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="13"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At 2 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.5" spread="8.55"/>
                    <measurement group_id="O2" value="-11.6" spread="11.16"/>
                    <measurement group_id="O3" value="-5.4" spread="9.27"/>
                    <measurement group_id="O4" value="-13.6" spread="15.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 4 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="14.99"/>
                    <measurement group_id="O2" value="-16.5" spread="15.00"/>
                    <measurement group_id="O3" value="-16.4" spread="14.55"/>
                    <measurement group_id="O4" value="-13.7" spread="17.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 8 weeks (EOT)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.9" spread="5.61"/>
                    <measurement group_id="O2" value="-23.5" spread="15.52"/>
                    <measurement group_id="O3" value="-19.2" spread="14.59"/>
                    <measurement group_id="O4" value="-16.3" spread="14.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Mean Value in Treatment Satisfaction (Patient's Global Impression of Change )</title>
        <description>The PGIC has a minimum possible score of 1 (very much improved) and a maximum possible score of 7 (very much worse). Subjects was asked to use a categorical scale with 7 categories to describe their global impression of change (PGIC) with study drug treatment. Subjects recorded their impression of change on paper at Weeks 2, 4, and 8 (EOT).&#xD;
Although the change from baseline (run-in phase [Days -7 to -1]) was specified as an outcome in this study, it was not calculated because the target enrollment was not met and no meaningful statistical analysis could be expected. Therefore, the mean value of patients at each point is shown instead.</description>
        <time_frame>2 weeks, 4 weeks and 8 weeks</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>MT-9938 2.5μg</title>
            <description>Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>MT-9938 5μg</title>
            <description>Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks</description>
          </group>
          <group group_id="O3">
            <title>MT-9938 10μg</title>
            <description>Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo (2capsules) once daily for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>The Mean Value in Treatment Satisfaction (Patient's Global Impression of Change )</title>
          <description>The PGIC has a minimum possible score of 1 (very much improved) and a maximum possible score of 7 (very much worse). Subjects was asked to use a categorical scale with 7 categories to describe their global impression of change (PGIC) with study drug treatment. Subjects recorded their impression of change on paper at Weeks 2, 4, and 8 (EOT).&#xD;
Although the change from baseline (run-in phase [Days -7 to -1]) was specified as an outcome in this study, it was not calculated because the target enrollment was not met and no meaningful statistical analysis could be expected. Therefore, the mean value of patients at each point is shown instead.</description>
          <population>ITT</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>2 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="0.64"/>
                    <measurement group_id="O2" value="3.1" spread="1.51"/>
                    <measurement group_id="O3" value="3.0" spread="0.87"/>
                    <measurement group_id="O4" value="2.6" spread="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="0.71"/>
                    <measurement group_id="O2" value="2.8" spread="1.36"/>
                    <measurement group_id="O3" value="2.5" spread="0.93"/>
                    <measurement group_id="O4" value="2.8" spread="1.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="0.98"/>
                    <measurement group_id="O2" value="1.9" spread="0.90"/>
                    <measurement group_id="O3" value="2.1" spread="1.17"/>
                    <measurement group_id="O4" value="2.2" spread="1.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in QoL Assessment (5-D-Itch Scale)</title>
        <description>The 5-D-Itch scale has a minimum possible score of 5 (better) and a maximum possible score of 25 (worse). Subjects was asked to assess QoL by means of the 5D-Itch-Scale at Baseline, Weeks 2, 4, and 8 (EOT). The 5D-Itch Scale is a 5-item (duration, degree, direction, disability, and distribution) multidimensional measure of pruritus itch. Change from Baseline (the Run-in Phase [Days -7 to -1]) were assessed. Amount of change score of plus indicates worsening, and minus indicates improvement.</description>
        <time_frame>2 weeks, 4 weeks and 8 weeks</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>MT-9938 2.5μg</title>
            <description>Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>MT-9938 5μg</title>
            <description>Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks</description>
          </group>
          <group group_id="O3">
            <title>MT-9938 10μg</title>
            <description>Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo (2capsules) once daily for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in QoL Assessment (5-D-Itch Scale)</title>
          <description>The 5-D-Itch scale has a minimum possible score of 5 (better) and a maximum possible score of 25 (worse). Subjects was asked to assess QoL by means of the 5D-Itch-Scale at Baseline, Weeks 2, 4, and 8 (EOT). The 5D-Itch Scale is a 5-item (duration, degree, direction, disability, and distribution) multidimensional measure of pruritus itch. Change from Baseline (the Run-in Phase [Days -7 to -1]) were assessed. Amount of change score of plus indicates worsening, and minus indicates improvement.</description>
          <population>ITT</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="13"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At 2 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.8" spread="2.12"/>
                    <measurement group_id="O2" value="-3.3" spread="2.46"/>
                    <measurement group_id="O3" value="-3.0" spread="2.62"/>
                    <measurement group_id="O4" value="-6.1" spread="5.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 4 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread="4.17"/>
                    <measurement group_id="O2" value="-5.1" spread="3.80"/>
                    <measurement group_id="O3" value="-5.6" spread="3.16"/>
                    <measurement group_id="O4" value="-5.7" spread="5.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 8 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.7" spread="3.90"/>
                    <measurement group_id="O2" value="-8.6" spread="4.25"/>
                    <measurement group_id="O3" value="-6.2" spread="5.01"/>
                    <measurement group_id="O4" value="-7.6" spread="4.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Number of Patients in Excoriation</title>
        <description>Investigator and/or the designated medically qualified staff assessed the subject's excoriation at Baseline, and weekly thereafter, by completing the subject's answers to the following questions:&#xD;
Excoriation present? Yes/No If yes, please rate the severity: Mild/Moderate/Severe&#xD;
Although the change from baseline (run-in phase [Days -7 to -1]) was specified as an outcome in this study, it was not calculated because the target enrollment was not met and no meaningful statistical analysis could be expected. Therefore, the number of patients at each point is shown instead.</description>
        <time_frame>2 weeks, 4 weeks and 8 weeks</time_frame>
        <population>Not all rows could be analyzed with the overall number analyzed due to several reasons (e.g. patient discontinuation, missing data etc.), so some rows have different number of subjects analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>MT-9938 2.5μg</title>
            <description>Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>MT-9938 5μg</title>
            <description>Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks</description>
          </group>
          <group group_id="O3">
            <title>MT-9938 10μg</title>
            <description>Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo (2capsules) once daily for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Patients in Excoriation</title>
          <description>Investigator and/or the designated medically qualified staff assessed the subject's excoriation at Baseline, and weekly thereafter, by completing the subject's answers to the following questions:&#xD;
Excoriation present? Yes/No If yes, please rate the severity: Mild/Moderate/Severe&#xD;
Although the change from baseline (run-in phase [Days -7 to -1]) was specified as an outcome in this study, it was not calculated because the target enrollment was not met and no meaningful statistical analysis could be expected. Therefore, the number of patients at each point is shown instead.</description>
          <population>Not all rows could be analyzed with the overall number analyzed due to several reasons (e.g. patient discontinuation, missing data etc.), so some rows have different number of subjects analyzed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Excoriation not present</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Excoriation not present</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Excoriation not present</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Excoriation not present</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events as a Measure of Safety and Tolerability</title>
        <description>The number of subjects with at least 1 treatment-emergent adverse event (TEAE). Please see the adverse event table for specific.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MT-9938 2.5μg</title>
            <description>Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>MT-9938 5μg</title>
            <description>Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks</description>
          </group>
          <group group_id="O3">
            <title>MT-9938 10μg</title>
            <description>Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo (2capsules) once daily for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events as a Measure of Safety and Tolerability</title>
          <description>The number of subjects with at least 1 treatment-emergent adverse event (TEAE). Please see the adverse event table for specific.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>8 weeks for treatment phase + 1 week follow-up visit after last dose</time_frame>
      <group_list>
        <group group_id="E1">
          <title>MT-9938 2.5μg</title>
          <description>Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks</description>
        </group>
        <group group_id="E2">
          <title>MT-9938 5μg</title>
          <description>Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks</description>
        </group>
        <group group_id="E3">
          <title>MT-9938 10μg</title>
          <description>Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks</description>
        </group>
        <group group_id="E4">
          <title>Placebo</title>
          <description>Placebo: Placebo (2capsules) once daily for 8 weeks</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 16.1</default_vocab>
        <default_assessment>Non-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="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac Failure Congestive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatitis Relapsing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <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="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Fluid Overload</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pleural Effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 16.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperprolactinaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
              </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 disclosure restriction on the PIs is that sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to sponsor for review. Sponsor can require changes to the communication which is considered confidential and/or proprietary. If necessary, sponsor shall have the right to request to delay the proposed disclosure for an additional 60 days.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trials Information Desk</name_or_title>
      <organization>Toray Industries, Inc</organization>
      <email>clinical-trials.toray.mb@mail.toray</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/NCT01660243
org study id: MT-9938-A01
nct id: NCT01660243
lead sponsor: 
has dmc: No
This study is being conducted to investigate the efficacy of MT-9938 compared with placebo
      after 2 weeks, to continue to evaluate efficacy for an additional 6 weeks, and to explore the
      effect of a reduction in itching intensity on health-related Quality of Life(QoL) domains,
      especially those which recent research suggests have a positive correlation with overall
      survival for this patient group. The study will consist of the following phases: Screening (1
      to 2 weeks), Run in (1 week), double-blind Treatment (8 weeks), Washout (1 week) culminating
      in a Follow-up Visit (1 week after the last dose).
This study has been terminated because of insufficient patient recruitment. There were no
      safety concerns.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in Worst-itching 11-point Numerical Rating Scale (NRS)
time frame: 2 weeks, 4 weeks and 8 week
description: The subject indicated the number on the line from left (0:no itching) to right (10:worst itch I have ever experienced). Assessments was made twice daily using an electronic Patient Reported Outcomes (ePRO) device from the Screening Visit to the Follow-up Visit (Week 9). The 2 daily assessments was separated by 12 h, at approximately 8 am and at approximately 8 pm. Subjects selected the number that best described the worst itch during the day (assessed at approximately 8 pm) or during the night (assessed at approximately 8 am). The day or night score, whichever was greater, was used to calculate the weekly average score and changes from baseline (average over the Run-in Phase [Days -7 to -1]) score in weekly average at 2, 4 and 8 weeks as specified in the protocol are reported. Amount of change score of plus indicates worsening, and minus indicates improvement.
measure: Change From Baseline in Worst-itching Visual Analog Scale (VAS)
time frame: 2 weeks, 4 weeks and 8 weeks
description: The subject placed a single vertical mark on the line of a VAS corresponding to degree of itching intensity from left (no itching) to right (worst itch I have ever experienced). The VAS represents a 100 mm line. It consists of 101 selectable regions and the subject's score on the VAS will correspond to the region (0 to 100) selected on the line. Assessments was made twice daily using an ePRO device from the Screening Visit to the Follow-up Visit (Week 9). The 2 daily assessments was separated by 12 h, in the morning at approximately 8 am and in the night at approximately 8 pm. Subjects put a single vertical mark on the line to show the intensity of your worst itching during the day or during the night. The day or night score, whichever was greater, was used to calculate the weekly average score and changes from baseline in weekly average at 2, 4 and 8 weeks as specified in the protocol are reported. Amount of change score of plus indicates worsening, and minus indicates improvement.
measure: Change From Baseline in Itch Severity Score
time frame: 2 weeks, 4 weeks and 8 weeks
description: The subject performed an assessment on day and nighttime symptoms of itch and effect of itch on sleep using a 5-point ordinal scale of itchiness (0 = none, 1 = mild, 2 = Moderate, 3=Severe, 4 = very severe). Assessments was made during each dialysis treatment (3x/week) and recorded on paper from the Screening Visit to the Follow-up Visit (Week 9). Change from Baseline (average over the Run-in Phase [Days -7 to -1]) in Weekly Averages of Itch Severity Score were assessed and score at 2, 4 and 8 weeks as specified in the protocol are reported. Amount of change score of plus indicates worsening, and minus indicates improvement.
measure: Change From Baseline in Sleep Quality Assessment
time frame: 2 weeks, 4 weeks and 8 weeks
description: The PSQI has a minimum possible score of 0 (better sleep quality) and a maximum possible score of 10 (worse sleep quality). Subjects was asked to rate their sleep experience during the previous week. Pittsburgh Sleep Quality Index (PSQI) modified assessment was made during the dialysis treatment 1x/week every week and recorded on paper from the Screening Visit to the Follow-up Visit (Week 9).Change from Baseline (the Run-in Phase [Days -7 to -1]) were assessed and score at 2, 4 and 8 weeks as specified in the protocol are reported. Amount of change score of plus indicates worsening, and minus indicates improvement.
measure: Change From Baseline in QoL Assessment (Skindex-10)
time frame: 2 weeks, 4 weeks and 8 weeks
description: The Skindex-10 has a minimum possible score of 0 (itching not bothersome) and a maximum possible score of 60 (itching very bothersome). The Skindex-10 is a self-administered questionnaire used to evaluate the health-related QoL in UP. It is comprised of 10 questions, adopted for pruritus from the Skindex-16, a widely used instrument for a variety of skin disease. Subjects was asked to identify on paper at Baseline and Weeks 2, 4, and 8 (EOT) what has bothered them most during the past week by marking along a scale 0 to 6 boxes from "never bothered" to "always bothered. Change from Baseline (the Run-in Phase [Days -7 to -1]) were assessed. Amount of change score of plus indicates worsening, and minus indicates improvement.
measure: The Mean Value in Treatment Satisfaction (Patient's Global Impression of Change )
time frame: 2 weeks, 4 weeks and 8 weeks
description: The PGIC has a minimum possible score of 1 (very much improved) and a maximum possible score of 7 (very much worse). Subjects was asked to use a categorical scale with 7 categories to describe their global impression of change (PGIC) with study drug treatment. Subjects recorded their impression of change on paper at Weeks 2, 4, and 8 (EOT).
Although the change from baseline (run-in phase [Days -7 to -1]) was specified as an outcome in this study, it was not calculated because the target enrollment was not met and no meaningful statistical analysis could be expected. Therefore, the mean value of patients at each point is shown instead.
measure: Change From Baseline in QoL Assessment (5-D-Itch Scale)
time frame: 2 weeks, 4 weeks and 8 weeks
description: The 5-D-Itch scale has a minimum possible score of 5 (better) and a maximum possible score of 25 (worse). Subjects was asked to assess QoL by means of the 5D-Itch-Scale at Baseline, Weeks 2, 4, and 8 (EOT). The 5D-Itch Scale is a 5-item (duration, degree, direction, disability, and distribution) multidimensional measure of pruritus itch. Change from Baseline (the Run-in Phase [Days -7 to -1]) were assessed. Amount of change score of plus indicates worsening, and minus indicates improvement.
measure: The Number of Patients in Excoriation
time frame: 2 weeks, 4 weeks and 8 weeks
description: Investigator and/or the designated medically qualified staff assessed the subject's excoriation at Baseline, and weekly thereafter, by completing the subject's answers to the following questions:
Excoriation present? Yes/No If yes, please rate the severity: Mild/Moderate/Severe
Although the change from baseline (run-in phase [Days -7 to -1]) was specified as an outcome in this study, it was not calculated because the target enrollment was not met and no meaningful statistical analysis could be expected. Therefore, the number of patients at each point is shown instead.
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
time frame: 8 weeks
description: The number of subjects with at least 1 treatment-emergent adverse event (TEAE). Please see the adverse event table for specific.
arm group label: MT-9938 2.5μg
arm group type: Active Comparator
arm group label: MT-9938 5μg
arm group type: Active Comparator
arm group label: MT-9938 10μg
arm group type: Active Comparator
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Nalfurafine hydrochloride(MT-9938) 2.5μg
description: 2.5 μg (2capsules) once daily for 8 weeks
arm group label: MT-9938 2.5μg
intervention type: Drug
intervention name: Nalfurafine hydrochloride(MT-9938) 5μg
description: 5 μg (2capsules) once daily for 8 weeks
arm group label: MT-9938 5μg
intervention type: Drug
intervention name: Nalfurafine hydrochloride(MT-9938) 10μg
description: 10 μg (2capsules) once daily for 8 weeks
arm group label: MT-9938 10μg
intervention type: Drug
intervention name: Placebo
description: Placebo (2capsules) once daily for 8 weeks
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Kidney Failure, Chronic
mesh term: Pruritus
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 