<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/NCT01727180</url>
  </required_header>
  <id_info>
    <org_study_id>100047-E</org_study_id>
    <nct_id>NCT01727180</nct_id>
  </id_info>
  <brief_title>Pruritus in Patients With Chronic Kidney Disease</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Far Eastern Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Far Eastern Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We believe that knowing characteristics of uremic pruritus is the foundation to investigate&#xD;
      its pathophysiology and offer better skin care for patients with chronic kidney disease. We&#xD;
      therefore conducted this cross-sectional study to evaluate the characteristics of uraemic&#xD;
      pruritus.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">June 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale (VAS)</measure>
    <time_frame>Once at the entry of the study</time_frame>
    <description>A visual analog scale (VAS) measuring the general severity of pruritus was reported from 0 to 10 (0 = no pruritus, 10 = worst pruritus imaginable</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">108</enrollment>
  <condition>Kidney Failure, Chronic</condition>
  <condition>Pruritus</condition>
  <arm_group>
    <arm_group_label>Chronic kidney disease</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire based on the McGill Pain Questionnaire</intervention_name>
    <description>Interview questionnaire based on the short form of the McGill Pain Questionnaire</description>
    <arm_group_label>Chronic kidney disease</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with CKD stage 3 to 5D, followed-up in the Far Eastern Memorial Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults older than 20 years old, with CKD stage 3 to 5D, with symptoms of pruritus.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who refused to answer the questionnaire or unable to understand the contents&#xD;
             of the questionnaire.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hon-Yen Wu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Far Eastern Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Far Eastern Memorial Hospital</name>
      <address>
        <city>New Taipei City</city>
        <zip>220</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <results_first_submitted>March 4, 2015</results_first_submitted>
  <results_first_submitted_qc>March 4, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 17, 2015</results_first_posted>
  <last_update_submitted>March 4, 2015</last_update_submitted>
  <last_update_submitted_qc>March 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Pruritus</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Chronic Kidney Disease</title>
          <description>Questionnaire based on the McGill Pain Questionnaire: Interview questionnaire based on the short form of the McGill Pain Questionnaire</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="108"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="108"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Chronic Kidney Disease</title>
          <description>Questionnaire based on the McGill Pain Questionnaire: Interview questionnaire based on the short form of the McGill Pain Questionnaire</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="108"/>
          </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="61.1" spread="12.9"/>
                  </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="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Visual Analog Scale (VAS)</title>
        <description>A visual analog scale (VAS) measuring the general severity of pruritus was reported from 0 to 10 (0 = no pruritus, 10 = worst pruritus imaginable</description>
        <time_frame>Once at the entry of the study</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Chronic Kidney Disease</title>
            <description>Questionnaire based on the McGill Pain Questionnaire: Interview questionnaire based on the short form of the McGill Pain Questionnaire</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analog Scale (VAS)</title>
          <description>A visual analog scale (VAS) measuring the general severity of pruritus was reported from 0 to 10 (0 = no pruritus, 10 = worst pruritus imaginable</description>
          <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="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.35" spread="2.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Chronic Kidney Disease</title>
          <description>Questionnaire based on the McGill Pain Questionnaire: Interview questionnaire based on the short form of the McGill Pain Questionnaire</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Hon-Yen Wu, MD, PHD</name_or_title>
      <organization>Far Eastern Memorial Hospital</organization>
      <phone>+886-2-8966-7000 ext 1164</phone>
      <email>honyenwu@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01727180
org study id: 100047-E
nct id: NCT01727180
lead sponsor: 
has dmc: No
We believe that knowing characteristics of uremic pruritus is the foundation to investigate
      its pathophysiology and offer better skin care for patients with chronic kidney disease. We
      therefore conducted this cross-sectional study to evaluate the characteristics of uraemic
      pruritus.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Visual Analog Scale (VAS)
time frame: Once at the entry of the study
description: A visual analog scale (VAS) measuring the general severity of pruritus was reported from 0 to 10 (0 = no pruritus, 10 = worst pruritus imaginable
arm group label: Chronic kidney disease
intervention type: Other
intervention name: Questionnaire based on the McGill Pain Questionnaire
description: Interview questionnaire based on the short form of the McGill Pain Questionnaire
arm group label: Chronic kidney disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Hon-Yen Wu, MD
role: Principal Investigator
affiliation: Far Eastern Memorial Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Renal Insufficiency
mesh term: Kidney Failure, Chronic
mesh term: Pruritus
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 