<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/NCT01732692</url>
  </required_header>
  <id_info>
    <org_study_id>MV-9999-301-RU</org_study_id>
    <secondary_id>U1111-1135-2011</secondary_id>
    <nct_id>NCT01732692</nct_id>
  </id_info>
  <brief_title>Evaluation of the Efficacy, Safety and Tolerance of Experimental Morning-only MOVIPREP® Bowel Preparation in Comparison With Split-dose With Nocturnal Pause MOVIPREP® Bowel Preparation</brief_title>
  <official_title>Multicenter Endoscopist-blinded Randomized Parallel-group Comparative Study to Assess Efficacy, Safety and Tolerance of Morning-only Dosing Compared to Control Split-dosing With Nocturnal Pause in MOVIPREP® Bowel Preparation Prior to Colonoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Norgine BV</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare colon cleansing quality induced by the 2 different modes of MOVIPREP® intake in 5&#xD;
      colon segments prior to colonoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All participants enrolled to the study will be allocated to one of two arms. Patients of the&#xD;
      experimental morning-only regimen arm will prepare and take MOVIPREP® solution in the full&#xD;
      dose - 2 litres of MOVIPREP® preparation in the early morning on the day of the colonoscopy&#xD;
      clinical procedure. Participants in the standard split-dose regimen arm will prepare and take&#xD;
      MOVIPREP® solution in split doses - ½ of dose (1 litre) the evening before + ½ of dose (1&#xD;
      litre) of MOVIPREP® preparation in the morning of the day of the colonoscopy.&#xD;
&#xD;
      The study consists of three visits. Participation in the study lasts no more than 11 days; 3&#xD;
      days as minimum.&#xD;
&#xD;
      There is no follow-up period planned except in case of any adverse events (AEs) when the&#xD;
      follow-up period will last until the participant has recovered or until all AE-related&#xD;
      queries for the participant have been resolved.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Successful Colon Cleansing</measure>
    <time_frame>1 day (the day of colonoscopy)</time_frame>
    <description>Bowel cleansing was assessed by a blinded endoscopist through visual evaluation of 5 colon segments and scored using the Harefield Cleansing Scale (HCS): A = success, all segments clean/scored 4 or 3; B = success, ≥1 segment with liquid/semi-solid amounts of stool, fully removable, ≥1 segment scored 2; C = failure, ≥1 segment with semi-solid or solid amounts of stool, at least 1 segment scored 1; and D = failure, ≥ 1 segment with irremovable, heavy, hard stools, ≥ 1 segment scored 0. Segmental evaluation of colon cleansing scores is as follows: 4: Colon empty and clean, no remaining stool or liquid. 3: Presence of clear liquid in the gut which can be removed by suction. 2: Brown liquid or semisolid remaining amounts of stool, fully removable. 1: Semisolid amounts of stool, only partially removable, difficult to make colonoscopy; 0: Irremovable, heavy, hard stools, colonoscopy impossible. Success of cleansing was defined as Grades of bowel cleansing А and В.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction of Colonoscopy Preparation (VAS)</measure>
    <time_frame>1 day (the day of colonoscopy)</time_frame>
    <description>Patient satisfaction was measured on a 100 mm visual analog scale (VAS) where 0 (left end of the line) is marked as &quot;totally unacceptable&quot; (lowest patient satisfaction of colonoscopy preparation) and 100 is &quot;fully acceptable&quot; (highest patient satisfaction with the procedure). Satisfaction was scored based on a mark placed on the line by the participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Compliance Score</measure>
    <time_frame>1 day (the day of colonoscopy)</time_frame>
    <description>Compliance score = 100 * (total amount MOVIPREP® intake) / (planned MOVIPREP intake).&#xD;
Total compliance score of MOVIPREP is the average score of the compliance for the first and second litre.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Compliance - Amount of Additional Clear Liquid Consumed</measure>
    <time_frame>1 day (the day of colonoscopy)</time_frame>
    <description>To prevent any potential dehydration risk participants were recommended the intake of at least 500 ml of additional clear liquid (juices without pulp, tea, water) per liter of the Moviprep solution. The amount of additional clear liquid taken is reported for each liter of Moviprep taken.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients Who Experienced Adverse Events (AEs)</measure>
    <time_frame>From first dose of study drug until the end of colonoscopy procedure, maximum of 24 hours.</time_frame>
    <description>An AE was a worsening in severity or frequency of a concomitant illness or any new illness diagnosed during the clinical trial period. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability / incapacity; is a congenital anomaly / birth defect; is medically important. Severity is a clinical observation and describes the intensity of the event: Mild: Transient symptoms, no interference with daily activities; Moderate: Marked symptoms, moderate interference with daily activities; Severe: Considerable interference with daily activities. Relatedness to study drug was assessed by the Investigator.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Bowel Preparation Prior to Endoscopic, Radiological and Other Examinations as Well as to Surgical Procedures Which Require Empty Bowel.</condition>
  <arm_group>
    <arm_group_label>MOVIPREP (Morning-only dose)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MOVIPREP (Split-dose)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MOVIPREP</intervention_name>
    <description>MOVIPREP solution</description>
    <arm_group_label>MOVIPREP (Morning-only dose)</arm_group_label>
    <arm_group_label>MOVIPREP (Split-dose)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male or female ≥18 years and ≤ 85 years&#xD;
&#xD;
          -  colonoscopy procedure indicated&#xD;
&#xD;
          -  willing to stay in the outpatient clinical site for colonoscopy and questionnaire&#xD;
             completion&#xD;
&#xD;
          -  willing and able to undergo study-related procedures&#xD;
&#xD;
          -  informed consent signed by a patient for participation in the study&#xD;
&#xD;
          -  negative pregnancy test in women with childbearing potential and consent for double&#xD;
             barrier method birth control for subjects, men and women, during the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ileus&#xD;
&#xD;
          -  suspected colonic tumor with manifestations of intestinal obstruction&#xD;
&#xD;
          -  delayed gastric emptying (gastroparesis), weak vomiting reflex, tendency to aspiration&#xD;
             and regurgitation&#xD;
&#xD;
          -  toxic megacolon which is a result of severe inflammatory conditions of the colon&#xD;
             including Crohn's disease and ulcerative colitis&#xD;
&#xD;
          -  suspected intestinal perforation or risk of gastrointestinal perforation&#xD;
&#xD;
          -  signs of severe intestinal bleeding&#xD;
&#xD;
          -  acute inflammatory anal or perianal pathology&#xD;
&#xD;
          -  severe concomitant diseases of internal organs&#xD;
&#xD;
          -  psychiatric diseases in aggravation stage&#xD;
&#xD;
          -  hypersensitivity to polyethylene glycol and/or any component of MOVIPREP® preparation&#xD;
&#xD;
          -  phenylketonuria or diagnosed glucose-6-phosphate dehydrogenate deficiency&#xD;
&#xD;
          -  unconsciousness&#xD;
&#xD;
          -  dehydration&#xD;
&#xD;
          -  severe inflammatory diseases&#xD;
&#xD;
          -  acute abdominal pain of unknown etiology&#xD;
&#xD;
          -  pregnancy and lactation period&#xD;
&#xD;
          -  participation in any other clinical study (including studies of experimental devices)&#xD;
             in 30 days prior participation in the present trial&#xD;
&#xD;
          -  patients who test positive for human immunodeficiency virus (HIV)/autoimmune disease&#xD;
             (AID), Wasserman reaction (RW) or hepatitis B virus (HBC)&#xD;
&#xD;
          -  any condition or circumstance that, in the opinion of the Investigator, would&#xD;
             compromise the safety of the participant or the quality of study data&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director Clinical Science</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Alma Ata</city>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint-Petersburg,</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint-Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kazakhstan</country>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <results_first_submitted>April 5, 2014</results_first_submitted>
  <results_first_submitted_qc>April 16, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 15, 2014</results_first_posted>
  <last_update_submitted>April 16, 2014</last_update_submitted>
  <last_update_submitted_qc>April 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bowel preparation, MOVIPREP®</keyword>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 6 investigative sites in the Russian Federation and the Republic of Kazakhstan from 22 November 2012 to 5 April 2013.</recruitment_details>
      <pre_assignment_details>Participants indicated for a colonoscopy were enrolled equally in 1 of 2 treatment groups, morning-only on the day of the clinical procedure or split-dosing in 2 stages with a nocturnal pause.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>MOVIPREP (Morning-only Dose)</title>
          <description>MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.</description>
        </group>
        <group group_id="P2">
          <title>MOVIPREP (Split-dose)</title>
          <description>MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="70"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="69"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>MOVIPREP (Morning-only Dose)</title>
          <description>MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.</description>
        </group>
        <group group_id="B2">
          <title>MOVIPREP (Split-dose)</title>
          <description>MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.</description>
        </group>
        <group group_id="B3">
          <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="70"/>
            <count group_id="B2" value="70"/>
            <count group_id="B3" value="140"/>
          </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="50.3" spread="17.41"/>
                    <measurement group_id="B2" value="49.1" spread="16.26"/>
                    <measurement group_id="B3" value="49.8" spread="16.79"/>
                  </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="38"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="93"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="171.1" spread="9.36"/>
                    <measurement group_id="B2" value="165.1" spread="7.83"/>
                    <measurement group_id="B3" value="168.1" spread="9.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73.5" spread="16.92"/>
                    <measurement group_id="B2" value="68.3" spread="13.86"/>
                    <measurement group_id="B3" value="71.1" spread="15.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.1" spread="5.30"/>
                    <measurement group_id="B2" value="25.1" spread="5.10"/>
                    <measurement group_id="B3" value="25.1" spread="5.25"/>
                  </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>Russia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kazakhstan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Successful Colon Cleansing</title>
        <description>Bowel cleansing was assessed by a blinded endoscopist through visual evaluation of 5 colon segments and scored using the Harefield Cleansing Scale (HCS): A = success, all segments clean/scored 4 or 3; B = success, ≥1 segment with liquid/semi-solid amounts of stool, fully removable, ≥1 segment scored 2; C = failure, ≥1 segment with semi-solid or solid amounts of stool, at least 1 segment scored 1; and D = failure, ≥ 1 segment with irremovable, heavy, hard stools, ≥ 1 segment scored 0. Segmental evaluation of colon cleansing scores is as follows: 4: Colon empty and clean, no remaining stool or liquid. 3: Presence of clear liquid in the gut which can be removed by suction. 2: Brown liquid or semisolid remaining amounts of stool, fully removable. 1: Semisolid amounts of stool, only partially removable, difficult to make colonoscopy; 0: Irremovable, heavy, hard stools, colonoscopy impossible. Success of cleansing was defined as Grades of bowel cleansing А and В.</description>
        <time_frame>1 day (the day of colonoscopy)</time_frame>
        <population>Intent-to-treat population</population>
        <group_list>
          <group group_id="O1">
            <title>MOVIPREP (Morning-only Dose)</title>
            <description>MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.</description>
          </group>
          <group group_id="O2">
            <title>MOVIPREP (Split-dose)</title>
            <description>MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Successful Colon Cleansing</title>
          <description>Bowel cleansing was assessed by a blinded endoscopist through visual evaluation of 5 colon segments and scored using the Harefield Cleansing Scale (HCS): A = success, all segments clean/scored 4 or 3; B = success, ≥1 segment with liquid/semi-solid amounts of stool, fully removable, ≥1 segment scored 2; C = failure, ≥1 segment with semi-solid or solid amounts of stool, at least 1 segment scored 1; and D = failure, ≥ 1 segment with irremovable, heavy, hard stools, ≥ 1 segment scored 0. Segmental evaluation of colon cleansing scores is as follows: 4: Colon empty and clean, no remaining stool or liquid. 3: Presence of clear liquid in the gut which can be removed by suction. 2: Brown liquid or semisolid remaining amounts of stool, fully removable. 1: Semisolid amounts of stool, only partially removable, difficult to make colonoscopy; 0: Irremovable, heavy, hard stools, colonoscopy impossible. Success of cleansing was defined as Grades of bowel cleansing А and В.</description>
          <population>Intent-to-treat population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.29"/>
                    <measurement group_id="O2" value="91.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The primary endpoint was analyzed by a non-inferiority test using the exact Farrington-Manning method. Non-inferiority of the two treatments was to be concluded if the lower end of the confidence interval of the difference the experimental treatment group (morning-only dose) - control treatment group (split dose) was above a non-inferiority margin of -0.15%.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <method>Exact Farrington - Manning</method>
            <param_type>Treatment Difference</param_type>
            <param_value>0.0286</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_lower_limit>-0.097</ci_lower_limit>
            <estimate_desc>Treatment Difference is the difference in proportion of participants with successful colon cleansing between treatments -experimental vs. control</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction of Colonoscopy Preparation (VAS)</title>
        <description>Patient satisfaction was measured on a 100 mm visual analog scale (VAS) where 0 (left end of the line) is marked as &quot;totally unacceptable&quot; (lowest patient satisfaction of colonoscopy preparation) and 100 is &quot;fully acceptable&quot; (highest patient satisfaction with the procedure). Satisfaction was scored based on a mark placed on the line by the participant.</description>
        <time_frame>1 day (the day of colonoscopy)</time_frame>
        <population>Intent-to-treat population with available VAS data.</population>
        <group_list>
          <group group_id="O1">
            <title>MOVIPREP (Morning-only Dose)</title>
            <description>MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.</description>
          </group>
          <group group_id="O2">
            <title>MOVIPREP (Split-dose)</title>
            <description>MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction of Colonoscopy Preparation (VAS)</title>
          <description>Patient satisfaction was measured on a 100 mm visual analog scale (VAS) where 0 (left end of the line) is marked as &quot;totally unacceptable&quot; (lowest patient satisfaction of colonoscopy preparation) and 100 is &quot;fully acceptable&quot; (highest patient satisfaction with the procedure). Satisfaction was scored based on a mark placed on the line by the participant.</description>
          <population>Intent-to-treat population with available VAS data.</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="70"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.2" spread="20.97"/>
                    <measurement group_id="O2" value="79.6" spread="23.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Compliance Score</title>
        <description>Compliance score = 100 * (total amount MOVIPREP® intake) / (planned MOVIPREP intake).&#xD;
Total compliance score of MOVIPREP is the average score of the compliance for the first and second litre.</description>
        <time_frame>1 day (the day of colonoscopy)</time_frame>
        <population>Intent-to-treat with available data</population>
        <group_list>
          <group group_id="O1">
            <title>MOVIPREP (Morning-only Dose)</title>
            <description>MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.</description>
          </group>
          <group group_id="O2">
            <title>MOVIPREP (Split-dose)</title>
            <description>MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Compliance Score</title>
          <description>Compliance score = 100 * (total amount MOVIPREP® intake) / (planned MOVIPREP intake).&#xD;
Total compliance score of MOVIPREP is the average score of the compliance for the first and second litre.</description>
          <population>Intent-to-treat with available data</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="70"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.1" spread="6.10"/>
                    <measurement group_id="O2" value="99.5" spread="2.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Compliance - Amount of Additional Clear Liquid Consumed</title>
        <description>To prevent any potential dehydration risk participants were recommended the intake of at least 500 ml of additional clear liquid (juices without pulp, tea, water) per liter of the Moviprep solution. The amount of additional clear liquid taken is reported for each liter of Moviprep taken.</description>
        <time_frame>1 day (the day of colonoscopy)</time_frame>
        <population>Intent-to-treat population with available data</population>
        <group_list>
          <group group_id="O1">
            <title>MOVIPREP (Morning-only Dose)</title>
            <description>MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.</description>
          </group>
          <group group_id="O2">
            <title>MOVIPREP (Split-dose)</title>
            <description>MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Compliance - Amount of Additional Clear Liquid Consumed</title>
          <description>To prevent any potential dehydration risk participants were recommended the intake of at least 500 ml of additional clear liquid (juices without pulp, tea, water) per liter of the Moviprep solution. The amount of additional clear liquid taken is reported for each liter of Moviprep taken.</description>
          <population>Intent-to-treat population with available data</population>
          <units>ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>After first liter of study drug</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="545.43" spread="128.6"/>
                    <measurement group_id="O2" value="640.29" spread="243.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After second liter of study drug</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="539.71" spread="116.5"/>
                    <measurement group_id="O2" value="585.65" spread="145.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients Who Experienced Adverse Events (AEs)</title>
        <description>An AE was a worsening in severity or frequency of a concomitant illness or any new illness diagnosed during the clinical trial period. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability / incapacity; is a congenital anomaly / birth defect; is medically important. Severity is a clinical observation and describes the intensity of the event: Mild: Transient symptoms, no interference with daily activities; Moderate: Marked symptoms, moderate interference with daily activities; Severe: Considerable interference with daily activities. Relatedness to study drug was assessed by the Investigator.</description>
        <time_frame>From first dose of study drug until the end of colonoscopy procedure, maximum of 24 hours.</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>MOVIPREP (Morning-only Dose)</title>
            <description>MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.</description>
          </group>
          <group group_id="O2">
            <title>MOVIPREP (Split-dose)</title>
            <description>MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Who Experienced Adverse Events (AEs)</title>
          <description>An AE was a worsening in severity or frequency of a concomitant illness or any new illness diagnosed during the clinical trial period. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability / incapacity; is a congenital anomaly / birth defect; is medically important. Severity is a clinical observation and describes the intensity of the event: Mild: Transient symptoms, no interference with daily activities; Moderate: Marked symptoms, moderate interference with daily activities; Severe: Considerable interference with daily activities. Relatedness to study drug was assessed by the Investigator.</description>
          <population>Safety population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any adverse event (AE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.6"/>
                    <measurement group_id="O2" value="61.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.9"/>
                    <measurement group_id="O2" value="54.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7"/>
                    <measurement group_id="O2" value="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AE leading to study discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-related adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.1"/>
                    <measurement group_id="O2" value="58.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours.</time_frame>
      <desc>At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>MOVIPREP (Morning-only Dose)</title>
          <description>MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.</description>
        </group>
        <group group_id="E2">
          <title>MOVIPREP (Split-dose)</title>
          <description>MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.</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="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 15.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="43" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Abdominal tenderness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Gastritis erosive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Product taste abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Blood calcium decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Blood calcium increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Blood chloride increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Blood iron decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Blood iron increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Body temperature increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Director</name_or_title>
      <organization>Takeda</organization>
      <phone>800-778-2860</phone>
      <email>clinicaltrialregistry@tpna.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/NCT01732692
org study id: MV-9999-301-RU
secondary id: U1111-1135-2011
nct id: NCT01732692
lead sponsor: 
collaborator: 
has dmc: No
To compare colon cleansing quality induced by the 2 different modes of MOVIPREP® intake in 5
      colon segments prior to colonoscopy.
All participants enrolled to the study will be allocated to one of two arms. Patients of the
      experimental morning-only regimen arm will prepare and take MOVIPREP® solution in the full
      dose - 2 litres of MOVIPREP® preparation in the early morning on the day of the colonoscopy
      clinical procedure. Participants in the standard split-dose regimen arm will prepare and take
      MOVIPREP® solution in split doses - ½ of dose (1 litre) the evening before + ½ of dose (1
      litre) of MOVIPREP® preparation in the morning of the day of the colonoscopy.

      The study consists of three visits. Participation in the study lasts no more than 11 days; 3
      days as minimum.

      There is no follow-up period planned except in case of any adverse events (AEs) when the
      follow-up period will last until the participant has recovered or until all AE-related
      queries for the participant have been resolved.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Percentage of Participants With Successful Colon Cleansing
time frame: 1 day (the day of colonoscopy)
description: Bowel cleansing was assessed by a blinded endoscopist through visual evaluation of 5 colon segments and scored using the Harefield Cleansing Scale (HCS): A = success, all segments clean/scored 4 or 3; B = success, ≥1 segment with liquid/semi-solid amounts of stool, fully removable, ≥1 segment scored 2; C = failure, ≥1 segment with semi-solid or solid amounts of stool, at least 1 segment scored 1; and D = failure, ≥ 1 segment with irremovable, heavy, hard stools, ≥ 1 segment scored 0. Segmental evaluation of colon cleansing scores is as follows: 4: Colon empty and clean, no remaining stool or liquid. 3: Presence of clear liquid in the gut which can be removed by suction. 2: Brown liquid or semisolid remaining amounts of stool, fully removable. 1: Semisolid amounts of stool, only partially removable, difficult to make colonoscopy; 0: Irremovable, heavy, hard stools, colonoscopy impossible. Success of cleansing was defined as Grades of bowel cleansing А and В.
measure: Patient Satisfaction of Colonoscopy Preparation (VAS)
time frame: 1 day (the day of colonoscopy)
description: Patient satisfaction was measured on a 100 mm visual analog scale (VAS) where 0 (left end of the line) is marked as "totally unacceptable" (lowest patient satisfaction of colonoscopy preparation) and 100 is "fully acceptable" (highest patient satisfaction with the procedure). Satisfaction was scored based on a mark placed on the line by the participant.
measure: Total Compliance Score
time frame: 1 day (the day of colonoscopy)
description: Compliance score = 100 * (total amount MOVIPREP® intake) / (planned MOVIPREP intake).
Total compliance score of MOVIPREP is the average score of the compliance for the first and second litre.
measure: Patient Compliance - Amount of Additional Clear Liquid Consumed
time frame: 1 day (the day of colonoscopy)
description: To prevent any potential dehydration risk participants were recommended the intake of at least 500 ml of additional clear liquid (juices without pulp, tea, water) per liter of the Moviprep solution. The amount of additional clear liquid taken is reported for each liter of Moviprep taken.
measure: Percentage of Patients Who Experienced Adverse Events (AEs)
time frame: From first dose of study drug until the end of colonoscopy procedure, maximum of 24 hours.
description: An AE was a worsening in severity or frequency of a concomitant illness or any new illness diagnosed during the clinical trial period. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability / incapacity; is a congenital anomaly / birth defect; is medically important. Severity is a clinical observation and describes the intensity of the event: Mild: Transient symptoms, no interference with daily activities; Moderate: Marked symptoms, moderate interference with daily activities; Severe: Considerable interference with daily activities. Relatedness to study drug was assessed by the Investigator.
arm group label: MOVIPREP (Morning-only dose)
arm group type: Experimental
description: MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
arm group label: MOVIPREP (Split-dose)
arm group type: Other
description: MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
intervention type: Drug
intervention name: MOVIPREP
description: MOVIPREP solution
arm group label: MOVIPREP (Morning-only dose)
arm group label: MOVIPREP (Split-dose)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Medical Director Clinical Science
role: Study Director
affiliation: Takeda
facility: 
facility: 
facility: 
facility: 
country: Kazakhstan
country: Russian Federation
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 