<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/NCT01665157</url>
  </required_header>
  <id_info>
    <org_study_id>NTUH201109018RD</org_study_id>
    <nct_id>NCT01665157</nct_id>
  </id_info>
  <brief_title>Efficacy and Acceptability of Low-Residue Diet Package (Enimaclin®) as Diet Control Before Colonoscopy</brief_title>
  <official_title>A Randomized, Single-blinded, Comparative Study to Evaluate the Efficacy and the Acceptability of Low-residue Diet Package (Enimaclin®) as Diet Control Before Colonoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and the acceptability of low-residue&#xD;
      diet package (Enimaclin®) as diet control before colonoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, we investigate a randomized, single-blinded, comparative study to evaluate the&#xD;
      efficacy and the acceptability of low-residue diet package (Enimaclin®) as diet control&#xD;
      before colonoscopy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</primary_completion_date>
  <phase>N/A</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>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Cleansing Level at Colonoscopy by Ottawa Bowel Preparation Scale</measure>
    <time_frame>1 day</time_frame>
    <description>Ottawa preparation scale: Colon is defined into 3 segments: Right(cecum, ascending), mid(transverse, descending), rectosigmoid. Each is scored from 0 to 4, 0 is best and 4 is worst. Fluid quantity of whole is scored as 0, small; 1, moderate; 2 large amount. The scale will be summation of the clearness of 3 segments of colon and overall fluid quantity. It ranged from 0 to 14, 0 is the most clean colon and 14 is the most dirty one. Segment score will be analyzed separately as continuous variable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Cleansing Level at Colonoscopy by Aronchick Scale</measure>
    <time_frame>1 day</time_frame>
    <description>The overall proportion of participants scored as Excellent or Good by Aronchick scale.&#xD;
Description of Aronchick scale:It categorized colon cleansing into 5 level: Excellent, good, fair, poor, inadequate. It is categorical and cannot be summed. We will present</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Volume of Purgatives That Ingested</measure>
    <time_frame>1 day</time_frame>
    <description>The total volume of PEG-ELS (Liter) that ingested or could be ingested by examinee before colonoscopy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Segmental Cleansing Level at Colonoscopy (Right Segment Preparation Failure)</measure>
    <time_frame>1 day</time_frame>
    <description>Segmental score of Ottawa bowel preparation scale was analyzed. The proportion of &quot;right segment&quot; preparation failure, defined as segmental score as &quot;3 poor&quot; or &quot;4 inadequate&quot;, was presented.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Willingness to Choose the Same Protocol After Different Low Residual Diet and PEG-ELS Protocol</measure>
    <time_frame>1 day</time_frame>
    <description>It represent the proportion of participants who wanted to choose the same protocol as they received in this trial.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol</measure>
    <time_frame>1 day</time_frame>
    <description>It represented the percentage of participants who is satisfied with the protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Convenience of Different Low Residual Diet and Bowel Preparation Protocol</measure>
    <time_frame>1 day</time_frame>
    <description>It represented the percentage of participants who thinks the protocol is easy to use.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Dietary Modification</condition>
  <arm_group>
    <arm_group_label>low-residue diet package (Enimaclin®)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low-residue diet package with normal amount 2L PEG-ELS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Self-controlled diet</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Self-controlled diet with normal amount of 2L PEG-ELS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-residue diet (Enimaclin®) package</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low-residue diet package with low volume 1.5L PEG-ELS</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Enimaclin®</intervention_name>
    <description>Enimaclin Colomil ® (Glico Co., Japan Osaka)，a low-residue diet package for each meal.&#xD;
The duration of study is one day before colonoscopy.</description>
    <arm_group_label>Low-residue diet (Enimaclin®) package</arm_group_label>
    <arm_group_label>low-residue diet package (Enimaclin®)</arm_group_label>
    <other_name>Enimaclin Colomil ®,a low-residue diet package</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Self-controlled diet</intervention_name>
    <description>Self-controlled low residue diet.</description>
    <arm_group_label>Self-controlled diet</arm_group_label>
    <other_name>Self-controlled low residue diet.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>2L PEG-ELS</intervention_name>
    <description>Normal volume of PEG-ELS</description>
    <arm_group_label>Self-controlled diet</arm_group_label>
    <arm_group_label>low-residue diet package (Enimaclin®)</arm_group_label>
    <other_name>Taiwan name: Niflec powder</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>low volume 1.5L PEG-ELS</intervention_name>
    <description>Low volume PEG-ELS</description>
    <arm_group_label>Low-residue diet (Enimaclin®) package</arm_group_label>
    <other_name>Taiwan name: Niflec powder</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Outpatient or healthy volunteer for health examination, 20~75 years old&#xD;
&#xD;
          -  Eligible for oral bowel preparation&#xD;
&#xD;
          -  BMI (Body Mass Index) ≤ 30&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with severe constipation (as fewer than three stools per week)&#xD;
&#xD;
          -  Patients with bowel obstruction&#xD;
&#xD;
          -  Patients contraindicated with treatment drug&#xD;
&#xD;
          -  Patients who need emergency medication&#xD;
&#xD;
          -  Ineligible for bowel preparation&#xD;
&#xD;
          -  Pregnant or breast-feeding&#xD;
&#xD;
          -  Patients with known allergies to treatment drug or low-residue diet package&#xD;
&#xD;
          -  Patients who are ineligible to enroll&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Han-Mo Chiu, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>NTUH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>E-Da Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital Bei-Hu Branch</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Medical University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>February 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <results_first_submitted>February 21, 2013</results_first_submitted>
  <results_first_submitted_qc>December 17, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 6, 2014</results_first_posted>
  <last_update_submitted>February 18, 2014</last_update_submitted>
  <last_update_submitted_qc>February 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diet Control before Colonoscopy</keyword>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment period: 14 months Recruitment location: GI outpatient clinic</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Low-residue Diet Package and 2L PEG</title>
          <description>Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS</description>
        </group>
        <group group_id="P2">
          <title>Self-controlled Diet and 2L PEG</title>
          <description>Self-controlled diet with normal amount 2L PEG-ELS</description>
        </group>
        <group group_id="P3">
          <title>Low-residue Diet Package and 1.5L PEG-ELS</title>
          <description>Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="60"/>
                <participants group_id="P3" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="60"/>
                <participants group_id="P3" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Low-residue Diet Package (Enimaclin®) and 2L PEG</title>
          <description>Low-residue diet package with normal amount of 2L PEG-ELS</description>
        </group>
        <group group_id="B2">
          <title>Self-controlled Diet and 2L PEG</title>
          <description>Self-controlled diet with normal amount of 2L PEG-ELS</description>
        </group>
        <group group_id="B3">
          <title>Low-residue Diet (Enimaclin®) Package and 1.5L PEG</title>
          <description>Low-residue diet package with normal amount of 1.5L PEG-ELS</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="60"/>
            <count group_id="B2" value="60"/>
            <count group_id="B3" value="60"/>
            <count group_id="B4" value="180"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="54"/>
                    <measurement group_id="B4" value="157"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.5" spread="10.6"/>
                    <measurement group_id="B2" value="51.3" spread="12.7"/>
                    <measurement group_id="B3" value="53.0" spread="11.0"/>
                    <measurement group_id="B4" value="52.3" spread="11.4"/>
                  </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="28"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="81"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="36"/>
                    <measurement group_id="B4" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Taiwan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="60"/>
                    <measurement group_id="B4" value="180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Cleansing Level at Colonoscopy by Ottawa Bowel Preparation Scale</title>
        <description>Ottawa preparation scale: Colon is defined into 3 segments: Right(cecum, ascending), mid(transverse, descending), rectosigmoid. Each is scored from 0 to 4, 0 is best and 4 is worst. Fluid quantity of whole is scored as 0, small; 1, moderate; 2 large amount. The scale will be summation of the clearness of 3 segments of colon and overall fluid quantity. It ranged from 0 to 14, 0 is the most clean colon and 14 is the most dirty one. Segment score will be analyzed separately as continuous variable.</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low-residue Diet Package and 2L PEG</title>
            <description>Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS</description>
          </group>
          <group group_id="O2">
            <title>Self-controlled Diet and 2L PEG</title>
            <description>Self-controlled diet with normal amount 2L PEG-ELS</description>
          </group>
          <group group_id="O3">
            <title>Low-residue Diet Package Plus 1.5L PEG</title>
            <description>Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Cleansing Level at Colonoscopy by Ottawa Bowel Preparation Scale</title>
          <description>Ottawa preparation scale: Colon is defined into 3 segments: Right(cecum, ascending), mid(transverse, descending), rectosigmoid. Each is scored from 0 to 4, 0 is best and 4 is worst. Fluid quantity of whole is scored as 0, small; 1, moderate; 2 large amount. The scale will be summation of the clearness of 3 segments of colon and overall fluid quantity. It ranged from 0 to 14, 0 is the most clean colon and 14 is the most dirty one. Segment score will be analyzed separately as continuous variable.</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="60"/>
                <count group_id="O2" value="60"/>
                <count group_id="O3" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.58" spread="2.15"/>
                    <measurement group_id="O2" value="3.22" spread="3.08"/>
                    <measurement group_id="O3" value="2.97" spread="2.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.435</p_value>
            <p_value_desc>Not significant</p_value_desc>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Cleansing Level at Colonoscopy by Aronchick Scale</title>
        <description>The overall proportion of participants scored as Excellent or Good by Aronchick scale.&#xD;
Description of Aronchick scale:It categorized colon cleansing into 5 level: Excellent, good, fair, poor, inadequate. It is categorical and cannot be summed. We will present</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low-residue Diet Package and 2L PEG</title>
            <description>Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS</description>
          </group>
          <group group_id="O2">
            <title>Self-controlled Diet and 2L PEG</title>
            <description>Self-controlled diet with normal amount 2L PEG-ELS</description>
          </group>
          <group group_id="O3">
            <title>Low-residue Diet Package Plus 1.5L PEG-ELS</title>
            <description>Low-residue diet package(Enimaclin) with reduced volume low volume 1.5L PEG-ELS</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Cleansing Level at Colonoscopy by Aronchick Scale</title>
          <description>The overall proportion of participants scored as Excellent or Good by Aronchick scale.&#xD;
Description of Aronchick scale:It categorized colon cleansing into 5 level: Excellent, good, fair, poor, inadequate. It is categorical and cannot be summed. We will present</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
                <count group_id="O3" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.7"/>
                    <measurement group_id="O2" value="76.7"/>
                    <measurement group_id="O3" value="78.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.046</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis: &quot;Low-residue diet package and 2L PEG&quot; vs. &quot;Self-controlled diet and 2L PEG&quot; provides same preparation quality.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.024</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.041</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Willingness to Choose the Same Protocol After Different Low Residual Diet and PEG-ELS Protocol</title>
        <description>It represent the proportion of participants who wanted to choose the same protocol as they received in this trial.</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low-residue Diet Package and 2L PEG</title>
            <description>Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS</description>
          </group>
          <group group_id="O2">
            <title>Self-controlled Diet and 2L PEG</title>
            <description>Self-controlled diet with normal amount 2L PEG-ELS</description>
          </group>
          <group group_id="O3">
            <title>Low-residue Diet Package and 1.5L PEG</title>
            <description>Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS</description>
          </group>
        </group_list>
        <measure>
          <title>Willingness to Choose the Same Protocol After Different Low Residual Diet and PEG-ELS Protocol</title>
          <description>It represent the proportion of participants who wanted to choose the same protocol as they received in this trial.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
                <count group_id="O3" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.3"/>
                    <measurement group_id="O2" value="90.0"/>
                    <measurement group_id="O3" value="95.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Volume of Purgatives That Ingested</title>
        <description>The total volume of PEG-ELS (Liter) that ingested or could be ingested by examinee before colonoscopy</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low-residue Diet Package and 2L PEG</title>
            <description>Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS</description>
          </group>
          <group group_id="O2">
            <title>Self-controlled Diet and 2L PEG</title>
            <description>Self-controlled diet with normal amount 2L PEG-ELS</description>
          </group>
          <group group_id="O3">
            <title>Low-residue Diet Package and 1.5L PEG</title>
            <description>Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS</description>
          </group>
        </group_list>
        <measure>
          <title>Total Volume of Purgatives That Ingested</title>
          <description>The total volume of PEG-ELS (Liter) that ingested or could be ingested by examinee before colonoscopy</description>
          <units>Liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
                <count group_id="O3" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.96" spread="0.16"/>
                    <measurement group_id="O2" value="1.98" spread="0.12"/>
                    <measurement group_id="O3" value="1.61" spread="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol</title>
        <description>It represented the percentage of participants who is satisfied with the protocol.</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low-residue Diet Package and 2L PEG</title>
            <description>Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS</description>
          </group>
          <group group_id="O2">
            <title>Self-controlled Diet and 2L PEG</title>
            <description>Self-controlled diet with normal amount 2L PEG-ELS</description>
          </group>
          <group group_id="O3">
            <title>Low-residue Diet Package and 1.5 L PEG-ELS</title>
            <description>Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol</title>
          <description>It represented the percentage of participants who is satisfied with the protocol.</description>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
                <count group_id="O3" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.3"/>
                    <measurement group_id="O2" value="36.7"/>
                    <measurement group_id="O3" value="76.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Convenience of Different Low Residual Diet and Bowel Preparation Protocol</title>
        <description>It represented the percentage of participants who thinks the protocol is easy to use.</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low-residue Diet Package and 2L PEG</title>
            <description>Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS</description>
          </group>
          <group group_id="O2">
            <title>Self-controlled Diet and 2L PEG</title>
            <description>Self-controlled diet with 2L PEG-ELS</description>
          </group>
          <group group_id="O3">
            <title>Low-residue Diet Package and 1.5L PEG</title>
            <description>Low-residue diet package(Enimaclin) with reduced volume 1.5L PEG-ELS</description>
          </group>
        </group_list>
        <measure>
          <title>Convenience of Different Low Residual Diet and Bowel Preparation Protocol</title>
          <description>It represented the percentage of participants who thinks the protocol is easy to use.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
                <count group_id="O3" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.3"/>
                    <measurement group_id="O2" value="76.7"/>
                    <measurement group_id="O3" value="93.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Segmental Cleansing Level at Colonoscopy (Right Segment Preparation Failure)</title>
        <description>Segmental score of Ottawa bowel preparation scale was analyzed. The proportion of &quot;right segment&quot; preparation failure, defined as segmental score as &quot;3 poor&quot; or &quot;4 inadequate&quot;, was presented.</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low-residue Diet Package and 2L PEG</title>
            <description>Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS</description>
          </group>
          <group group_id="O2">
            <title>Self-controlled Diet and 2L PEG</title>
            <description>Self-controlled diet with normal amount 2L PEG-ELS</description>
          </group>
          <group group_id="O3">
            <title>Low-residue Diet Package Plus 1.5L PEG</title>
            <description>Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS</description>
          </group>
        </group_list>
        <measure>
          <title>Segmental Cleansing Level at Colonoscopy (Right Segment Preparation Failure)</title>
          <description>Segmental score of Ottawa bowel preparation scale was analyzed. The proportion of &quot;right segment&quot; preparation failure, defined as segmental score as &quot;3 poor&quot; or &quot;4 inadequate&quot;, was presented.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
                <count group_id="O3" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7"/>
                    <measurement group_id="O2" value="15.0"/>
                    <measurement group_id="O3" value="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.025</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Low-residue Diet Package</title>
          <description>Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS</description>
        </group>
        <group group_id="E2">
          <title>Self-controlled Diet</title>
          <description>Self-controlled diet with normal amount 2L PEG-ELS</description>
        </group>
        <group group_id="E3">
          <title>Low-residue Diet Package Plus 1.5L PEG-ELS</title>
          <description>Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS</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="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <description>Mild abdominal pain noted after bowel preparation.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="60"/>
              </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>Han-Mo Chiu, M.D., Ph.D.</name_or_title>
      <organization>National Taiwan University Hospital</organization>
      <email>hanmochiu@ntu.edu.tw</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/NCT01665157
org study id: NTUH201109018RD
nct id: NCT01665157
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the efficacy and the acceptability of low-residue
      diet package (Enimaclin®) as diet control before colonoscopy.
In this study, we investigate a randomized, single-blinded, comparative study to evaluate the
      efficacy and the acceptability of low-residue diet package (Enimaclin®) as diet control
      before colonoscopy.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Investigator)
measure: Overall Cleansing Level at Colonoscopy by Ottawa Bowel Preparation Scale
time frame: 1 day
description: Ottawa preparation scale: Colon is defined into 3 segments: Right(cecum, ascending), mid(transverse, descending), rectosigmoid. Each is scored from 0 to 4, 0 is best and 4 is worst. Fluid quantity of whole is scored as 0, small; 1, moderate; 2 large amount. The scale will be summation of the clearness of 3 segments of colon and overall fluid quantity. It ranged from 0 to 14, 0 is the most clean colon and 14 is the most dirty one. Segment score will be analyzed separately as continuous variable.
measure: Overall Cleansing Level at Colonoscopy by Aronchick Scale
time frame: 1 day
description: The overall proportion of participants scored as Excellent or Good by Aronchick scale.
Description of Aronchick scale:It categorized colon cleansing into 5 level: Excellent, good, fair, poor, inadequate. It is categorical and cannot be summed. We will present
measure: Total Volume of Purgatives That Ingested
time frame: 1 day
description: The total volume of PEG-ELS (Liter) that ingested or could be ingested by examinee before colonoscopy
measure: Segmental Cleansing Level at Colonoscopy (Right Segment Preparation Failure)
time frame: 1 day
description: Segmental score of Ottawa bowel preparation scale was analyzed. The proportion of "right segment" preparation failure, defined as segmental score as "3 poor" or "4 inadequate", was presented.
measure: Willingness to Choose the Same Protocol After Different Low Residual Diet and PEG-ELS Protocol
time frame: 1 day
description: It represent the proportion of participants who wanted to choose the same protocol as they received in this trial.
measure: Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol
time frame: 1 day
description: It represented the percentage of participants who is satisfied with the protocol.
measure: Convenience of Different Low Residual Diet and Bowel Preparation Protocol
time frame: 1 day
description: It represented the percentage of participants who thinks the protocol is easy to use.
arm group label: low-residue diet package (Enimaclin®)
arm group type: Experimental
description: Low-residue diet package with normal amount 2L PEG-ELS
arm group label: Self-controlled diet
arm group type: Placebo Comparator
description: Self-controlled diet with normal amount of 2L PEG-ELS
arm group label: Low-residue diet (Enimaclin®) package
arm group type: Experimental
description: Low-residue diet package with low volume 1.5L PEG-ELS
intervention type: Dietary Supplement
intervention name: Enimaclin®
description: Enimaclin Colomil ® (Glico Co., Japan Osaka)，a low-residue diet package for each meal.
The duration of study is one day before colonoscopy.
arm group label: Low-residue diet (Enimaclin®) package
arm group label: low-residue diet package (Enimaclin®)
other name: Enimaclin Colomil ®,a low-residue diet package
intervention type: Other
intervention name: Self-controlled diet
description: Self-controlled low residue diet.
arm group label: Self-controlled diet
other name: Self-controlled low residue diet.
intervention type: Drug
intervention name: 2L PEG-ELS
description: Normal volume of PEG-ELS
arm group label: Self-controlled diet
arm group label: low-residue diet package (Enimaclin®)
other name: Taiwan name: Niflec powder
intervention type: Drug
intervention name: low volume 1.5L PEG-ELS
description: Low volume PEG-ELS
arm group label: Low-residue diet (Enimaclin®) package
other name: Taiwan name: Niflec powder
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Han-Mo Chiu, M.D., Ph.D.
role: Principal Investigator
affiliation: NTUH
facility: 
facility: 
facility: 
facility: 
country: Taiwan
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 