<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/NCT01719653</url>
  </required_header>
  <id_info>
    <org_study_id>1220121180</org_study_id>
    <nct_id>NCT01719653</nct_id>
  </id_info>
  <brief_title>A Comparison of 5 Low Volume Bowel Preparations</brief_title>
  <official_title>A Randomized Comparison of Five Low Volume Bowel Preparations for Colonoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gastroenterology Services, Ltd.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gastroenterology Services, Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this investigation is to compare 3 versions of MiraLAX/Gatorade, MoviPrep and&#xD;
      SUPREP to see which preparation cleanses the colon best and which preparation is best&#xD;
      tolerated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>Phase 4</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>Chicago Bowel Preparation Scale</measure>
    <time_frame>At completion of colonoscopy - day 1</time_frame>
    <description>The quality of the colon preparation as graded using our new Chicago Bowel Preparation Scale (BPS) (Adventist Midwest Region Institutional Review Board, AMH 2010-01-80; ClinicalTrials.gov NCT01063049). Chicago BPS total score is ranges from 0 (very poor) to 36 (outstanding). Modified Chicago BPS total score is ranges from 0 (very poor) to 33 (outstanding). Chicago BPS Fluid score is ranges from 0 (dry) to 3 (wet).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Boston Bowel Preparation Scale</measure>
    <time_frame>At completion of colonoscopy - day 1</time_frame>
    <description>The quality of the colon preparation as graded using Boston Bowel Preparation total scores is range from 0 (very poor) to 9 (outstanding).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adequate/Inadequate Scale</measure>
    <time_frame>At completion of colonoscopy - day 1</time_frame>
    <description>The cleanliness of the colon as rated by the gastroenterologist using an adequate/inadequate scale where an adequate preparation is defined as being able to see at least 95% of the mucosa of the colon after washing and suctioning; otherwise, the preparation is rated as inadequate.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">1079</enrollment>
  <condition>Bowel Preparation for Colonoscopy</condition>
  <arm_group>
    <arm_group_label>MiraLAX 306 g (Day-Prior)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MiraLAX 357 g (Day-Prior)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MiraLAX 306 g (Split-Dose)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MoviPrep (Split-Dose)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SUPREP (Split-Dose)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MiraLAX</intervention_name>
    <description>MiraLAX consumed as described in each arm.</description>
    <arm_group_label>MiraLAX 306 g (Day-Prior)</arm_group_label>
    <arm_group_label>MiraLAX 306 g (Split-Dose)</arm_group_label>
    <arm_group_label>MiraLAX 357 g (Day-Prior)</arm_group_label>
    <other_name>PEG-3350</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gatorade</intervention_name>
    <description>Gatorade consumed as described in each arm.</description>
    <arm_group_label>MiraLAX 306 g (Day-Prior)</arm_group_label>
    <arm_group_label>MiraLAX 306 g (Split-Dose)</arm_group_label>
    <arm_group_label>MiraLAX 357 g (Day-Prior)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MoviPrep</intervention_name>
    <description>MoviPrep consumed as described in each arm.</description>
    <arm_group_label>MoviPrep (Split-Dose)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SUPREP</intervention_name>
    <description>SUPREP consumed as described in each arm.</description>
    <arm_group_label>SUPREP (Split-Dose)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients at least 18 years old planning to undergo an elective colonoscopy will be&#xD;
             eligible for inclusion in our study. We would prefer to exclude as few groups as&#xD;
             possible since in clinical practice these less well studied groups often need a&#xD;
             colonoscopy and will need to have a colonoscopy preparation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who are allergic (this is very rare) or intolerant to any of the study drugs.&#xD;
&#xD;
          2. Patients who are pregnant.&#xD;
&#xD;
          3. Patients who required multiple day colon preparations (2 days prior and 1 day prior)&#xD;
             in the past will be excluded.&#xD;
&#xD;
          4. Patients with ileus, gastrointestinal obstruction, gastric retention, bowel&#xD;
             perforation, toxic colitis or toxic megacolon would not be considered elective&#xD;
             colonoscopies and are excluded.&#xD;
&#xD;
          5. Patients with known renal disease (baseline creatinine greater than 1.50 mg/dl) will&#xD;
             need to be excluded due to the magnesium in SUPREP which is contraindicated in&#xD;
             patients with significant renal disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Gerard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gastroenterology Services, Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gastroenterology Services</name>
      <address>
        <city>Downers Grove</city>
        <state>Illinois</state>
        <zip>60515</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Gerard DP, Foster DB, Holden JL, Kang J, Raiser MW. Clinical Trial of 1000 Subjects Randomized to 5 Low-Volume Bowel Preparations for Colonoscopy and Their Acceptance of Split-Dose Bowel Preparations. J Clin Gastroenterol. 2017 Jul;51(6):512-521. doi: 10.1097/MCG.0000000000000575.</citation>
    <PMID>27433812</PMID>
  </results_reference>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>October 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <results_first_submitted>March 23, 2017</results_first_submitted>
  <results_first_submitted_qc>March 23, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 24, 2017</results_first_posted>
  <last_update_submitted>March 23, 2017</last_update_submitted>
  <last_update_submitted_qc>March 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colonoscopy</keyword>
  <keyword>Bowel Preparation</keyword>
  <keyword>MiraLAX</keyword>
  <keyword>Gatorade</keyword>
  <keyword>PEG-3350</keyword>
  <keyword>MoviPrep</keyword>
  <keyword>SUPREP</keyword>
  <keyword>Chicago Bowel Preparation Scale</keyword>
  <keyword>Boston Bowel Preparation Scale</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polyethylene glycol 3350</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>MiraLAX 306 g (Day-Prior)</title>
          <description>MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM&#xD;
MiraLAX: MiraLAX consumed as described in each arm.&#xD;
Gatorade: Gatorade consumed as described in each arm.</description>
        </group>
        <group group_id="P2">
          <title>MiraLAX 357 g (Day-Prior)</title>
          <description>MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.&#xD;
MiraLAX: MiraLAX consumed as described in each arm.&#xD;
Gatorade: Gatorade consumed as described in each arm.</description>
        </group>
        <group group_id="P3">
          <title>MiraLAX 306 g (Split-Dose)</title>
          <description>MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.&#xD;
MiraLAX: MiraLAX consumed as described in each arm.&#xD;
Gatorade: Gatorade consumed as described in each arm.</description>
        </group>
        <group group_id="P4">
          <title>MoviPrep (Split-Dose)</title>
          <description>MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.&#xD;
MoviPrep: MoviPrep consumed as described in each arm.</description>
        </group>
        <group group_id="P5">
          <title>SUPREP (Split-Dose)</title>
          <description>SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.&#xD;
SUPREP: SUPREP consumed as described in each arm.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="209"/>
                <participants group_id="P2" count="213"/>
                <participants group_id="P3" count="218"/>
                <participants group_id="P4" count="218"/>
                <participants group_id="P5" count="221"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="200"/>
                <participants group_id="P2" count="200"/>
                <participants group_id="P3" count="200"/>
                <participants group_id="P4" count="200"/>
                <participants group_id="P5" count="200"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="18"/>
                <participants group_id="P4" count="18"/>
                <participants group_id="P5" count="21"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>MiraLAX 306 g (Day-Prior)</title>
          <description>MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM&#xD;
MiraLAX: MiraLAX consumed as described in each arm.&#xD;
Gatorade: Gatorade consumed as described in each arm.</description>
        </group>
        <group group_id="B2">
          <title>MiraLAX 357 g (Day-Prior)</title>
          <description>MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.&#xD;
MiraLAX: MiraLAX consumed as described in each arm.&#xD;
Gatorade: Gatorade consumed as described in each arm.</description>
        </group>
        <group group_id="B3">
          <title>MiraLAX 306 g (Split-Dose)</title>
          <description>MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.&#xD;
MiraLAX: MiraLAX consumed as described in each arm.&#xD;
Gatorade: Gatorade consumed as described in each arm.</description>
        </group>
        <group group_id="B4">
          <title>MoviPrep (Split-Dose)</title>
          <description>MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.&#xD;
MoviPrep: MoviPrep consumed as described in each arm.</description>
        </group>
        <group group_id="B5">
          <title>SUPREP (Split-Dose)</title>
          <description>SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.&#xD;
SUPREP: SUPREP consumed as described in each arm.</description>
        </group>
        <group group_id="B6">
          <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="200"/>
            <count group_id="B2" value="200"/>
            <count group_id="B3" value="200"/>
            <count group_id="B4" value="200"/>
            <count group_id="B5" value="200"/>
            <count group_id="B6" value="1000"/>
          </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="60.9" spread="12.7"/>
                    <measurement group_id="B2" value="61.3" spread="12.4"/>
                    <measurement group_id="B3" value="59.1" spread="11.3"/>
                    <measurement group_id="B4" value="60.1" spread="11.4"/>
                    <measurement group_id="B5" value="60.6" spread="11.2"/>
                    <measurement group_id="B6" value="60.4" spread="11.8"/>
                  </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="99"/>
                    <measurement group_id="B2" value="99"/>
                    <measurement group_id="B3" value="101"/>
                    <measurement group_id="B4" value="97"/>
                    <measurement group_id="B5" value="99"/>
                    <measurement group_id="B6" value="495"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="99"/>
                    <measurement group_id="B4" value="103"/>
                    <measurement group_id="B5" value="101"/>
                    <measurement group_id="B6" value="505"/>
                  </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>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="200"/>
                    <measurement group_id="B2" value="200"/>
                    <measurement group_id="B3" value="200"/>
                    <measurement group_id="B4" value="200"/>
                    <measurement group_id="B5" value="200"/>
                    <measurement group_id="B6" value="1000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Chicago Bowel Preparation Scale</title>
        <description>The quality of the colon preparation as graded using our new Chicago Bowel Preparation Scale (BPS) (Adventist Midwest Region Institutional Review Board, AMH 2010-01-80; ClinicalTrials.gov NCT01063049). Chicago BPS total score is ranges from 0 (very poor) to 36 (outstanding). Modified Chicago BPS total score is ranges from 0 (very poor) to 33 (outstanding). Chicago BPS Fluid score is ranges from 0 (dry) to 3 (wet).</description>
        <time_frame>At completion of colonoscopy - day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MiraLAX 306 g (Day-Prior)</title>
            <description>MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM&#xD;
MiraLAX: MiraLAX consumed as described in each arm.&#xD;
Gatorade: Gatorade consumed as described in each arm.</description>
          </group>
          <group group_id="O2">
            <title>MiraLAX 357 g (Day-Prior)</title>
            <description>MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.&#xD;
MiraLAX: MiraLAX consumed as described in each arm.&#xD;
Gatorade: Gatorade consumed as described in each arm.</description>
          </group>
          <group group_id="O3">
            <title>MiraLAX 306 g (Split-Dose)</title>
            <description>MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.&#xD;
MiraLAX: MiraLAX consumed as described in each arm.&#xD;
Gatorade: Gatorade consumed as described in each arm.</description>
          </group>
          <group group_id="O4">
            <title>MoviPrep (Split-Dose)</title>
            <description>MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.&#xD;
MoviPrep: MoviPrep consumed as described in each arm.</description>
          </group>
          <group group_id="O5">
            <title>SUPREP (Split-Dose)</title>
            <description>SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.&#xD;
SUPREP: SUPREP consumed as described in each arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Chicago Bowel Preparation Scale</title>
          <description>The quality of the colon preparation as graded using our new Chicago Bowel Preparation Scale (BPS) (Adventist Midwest Region Institutional Review Board, AMH 2010-01-80; ClinicalTrials.gov NCT01063049). Chicago BPS total score is ranges from 0 (very poor) to 36 (outstanding). Modified Chicago BPS total score is ranges from 0 (very poor) to 33 (outstanding). Chicago BPS Fluid score is ranges from 0 (dry) to 3 (wet).</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="200"/>
                <count group_id="O2" value="200"/>
                <count group_id="O3" value="200"/>
                <count group_id="O4" value="200"/>
                <count group_id="O5" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Chicago BPS Total Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.54" spread="4.28"/>
                    <measurement group_id="O2" value="34.00" spread="4.25"/>
                    <measurement group_id="O3" value="34.67" spread="3.58"/>
                    <measurement group_id="O4" value="34.95" spread="3.39"/>
                    <measurement group_id="O5" value="35.16" spread="2.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Modified Chicago BPS Total Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.82" spread="3.59"/>
                    <measurement group_id="O2" value="32.14" spread="3.69"/>
                    <measurement group_id="O3" value="32.33" spread="2.93"/>
                    <measurement group_id="O4" value="32.54" spread="2.92"/>
                    <measurement group_id="O5" value="32.65" spread="1.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chicago BPS Fluid Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.90" spread="0.83"/>
                    <measurement group_id="O2" value="1.03" spread="0.89"/>
                    <measurement group_id="O3" value="1.84" spread="0.90"/>
                    <measurement group_id="O4" value="1.45" spread="0.82"/>
                    <measurement group_id="O5" value="1.30" spread="0.91"/>
                  </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>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>All 5 arms were compared pair-wise.&#xD;
1=G+PEG-306 2=G+PEG-357 3=G+PEG-Split 4=PEG+Asc-Split 5=SS-Split</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.005</p_value>
            <p_value_desc>Chicago BPS Total Score -- 1 was lower than 3,4,5; 2 was lower than 5. Modified Chicago BPS Total Score -- 1 were lower than 5. Chicago BPS Fluid Score -- 1 was dryer than 3,4,5; 2 was dryer than 3,4,5; 3 was wetter than 4,5.</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Boston Bowel Preparation Scale</title>
        <description>The quality of the colon preparation as graded using Boston Bowel Preparation total scores is range from 0 (very poor) to 9 (outstanding).</description>
        <time_frame>At completion of colonoscopy - day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MiraLAX 306 g (Day-Prior)</title>
            <description>MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM&#xD;
MiraLAX: MiraLAX consumed as described in each arm.&#xD;
Gatorade: Gatorade consumed as described in each arm.</description>
          </group>
          <group group_id="O2">
            <title>MiraLAX 357 g (Day-Prior)</title>
            <description>MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.&#xD;
MiraLAX: MiraLAX consumed as described in each arm.&#xD;
Gatorade: Gatorade consumed as described in each arm.</description>
          </group>
          <group group_id="O3">
            <title>MiraLAX 306 g (Split-Dose)</title>
            <description>MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.&#xD;
MiraLAX: MiraLAX consumed as described in each arm.&#xD;
Gatorade: Gatorade consumed as described in each arm.</description>
          </group>
          <group group_id="O4">
            <title>MoviPrep (Split-Dose)</title>
            <description>MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.&#xD;
MoviPrep: MoviPrep consumed as described in each arm.</description>
          </group>
          <group group_id="O5">
            <title>SUPREP (Split-Dose)</title>
            <description>SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.&#xD;
SUPREP: SUPREP consumed as described in each arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Boston Bowel Preparation Scale</title>
          <description>The quality of the colon preparation as graded using Boston Bowel Preparation total scores is range from 0 (very poor) to 9 (outstanding).</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="200"/>
                <count group_id="O2" value="200"/>
                <count group_id="O3" value="200"/>
                <count group_id="O4" value="200"/>
                <count group_id="O5" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.39" spread="1.36"/>
                    <measurement group_id="O2" value="8.57" spread="1.16"/>
                    <measurement group_id="O3" value="8.66" spread="1.16"/>
                    <measurement group_id="O4" value="8.80" spread="1.04"/>
                    <measurement group_id="O5" value="8.80" spread="0.77"/>
                  </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>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>All 5 arms were compared pair-wise.&#xD;
1=G+PEG-306 2=G+PEG-357 3=G+PEG-Split 4=PEG+Asc-Split 5=SS-Split</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>1 was lower than 4,5.</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adequate/Inadequate Scale</title>
        <description>The cleanliness of the colon as rated by the gastroenterologist using an adequate/inadequate scale where an adequate preparation is defined as being able to see at least 95% of the mucosa of the colon after washing and suctioning; otherwise, the preparation is rated as inadequate.</description>
        <time_frame>At completion of colonoscopy - day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MiraLAX 306 g (Day-Prior)</title>
            <description>MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM&#xD;
MiraLAX: MiraLAX consumed as described in each arm.&#xD;
Gatorade: Gatorade consumed as described in each arm.</description>
          </group>
          <group group_id="O2">
            <title>MiraLAX 357 g (Day-Prior)</title>
            <description>MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.&#xD;
MiraLAX: MiraLAX consumed as described in each arm.&#xD;
Gatorade: Gatorade consumed as described in each arm.</description>
          </group>
          <group group_id="O3">
            <title>MiraLAX 306 g (Split-Dose)</title>
            <description>MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.&#xD;
MiraLAX: MiraLAX consumed as described in each arm.&#xD;
Gatorade: Gatorade consumed as described in each arm.</description>
          </group>
          <group group_id="O4">
            <title>MoviPrep (Split-Dose)</title>
            <description>MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.&#xD;
MoviPrep: MoviPrep consumed as described in each arm.</description>
          </group>
          <group group_id="O5">
            <title>SUPREP (Split-Dose)</title>
            <description>SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.&#xD;
SUPREP: SUPREP consumed as described in each arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Adequate/Inadequate Scale</title>
          <description>The cleanliness of the colon as rated by the gastroenterologist using an adequate/inadequate scale where an adequate preparation is defined as being able to see at least 95% of the mucosa of the colon after washing and suctioning; otherwise, the preparation is rated as inadequate.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
                <count group_id="O2" value="200"/>
                <count group_id="O3" value="200"/>
                <count group_id="O4" value="200"/>
                <count group_id="O5" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Adequate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="195"/>
                    <measurement group_id="O2" value="196"/>
                    <measurement group_id="O3" value="198"/>
                    <measurement group_id="O4" value="197"/>
                    <measurement group_id="O5" value="197"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Inadequate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="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>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>All 5 arms were compared pair-wise.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&gt;0.005</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>MiraLAX 306 g (Day-Prior)</title>
          <description>MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM&#xD;
MiraLAX: MiraLAX consumed as described in each arm.&#xD;
Gatorade: Gatorade consumed as described in each arm.</description>
        </group>
        <group group_id="E2">
          <title>MiraLAX 357 g (Day-Prior)</title>
          <description>MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.&#xD;
MiraLAX: MiraLAX consumed as described in each arm.&#xD;
Gatorade: Gatorade consumed as described in each arm.</description>
        </group>
        <group group_id="E3">
          <title>MiraLAX 306 g (Split-Dose)</title>
          <description>MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.&#xD;
MiraLAX: MiraLAX consumed as described in each arm.&#xD;
Gatorade: Gatorade consumed as described in each arm.</description>
        </group>
        <group group_id="E4">
          <title>MoviPrep (Split-Dose)</title>
          <description>MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.&#xD;
MoviPrep: MoviPrep consumed as described in each arm.</description>
        </group>
        <group group_id="E5">
          <title>SUPREP (Split-Dose)</title>
          <description>SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.&#xD;
SUPREP: SUPREP consumed as described in each arm.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="119" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="122" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="126" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="110" subjects_at_risk="200"/>
                <counts group_id="E5" subjects_affected="111" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="65" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="80" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="66" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="65" subjects_at_risk="200"/>
                <counts group_id="E5" subjects_affected="70" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="200"/>
                <counts group_id="E5" subjects_affected="13" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Abdominal Cramps/Pain</sub_title>
                <counts group_id="E1" subjects_affected="66" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="70" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="68" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="75" subjects_at_risk="200"/>
                <counts group_id="E5" subjects_affected="78" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Bloating</sub_title>
                <counts group_id="E1" subjects_affected="119" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="122" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="126" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="110" subjects_at_risk="200"/>
                <counts group_id="E5" subjects_affected="111" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>David Gerard, MD</name_or_title>
      <organization>Gastroenterology Services, Ltd</organization>
      <phone>630 969 1167</phone>
      <email>davidpgerard@comcast.net</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/NCT01719653
org study id: 1220121180
nct id: NCT01719653
lead sponsor: 
has dmc: Yes
The purpose of this investigation is to compare 3 versions of MiraLAX/Gatorade, MoviPrep and
      SUPREP to see which preparation cleanses the colon best and which preparation is best
      tolerated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Chicago Bowel Preparation Scale
time frame: At completion of colonoscopy - day 1
description: The quality of the colon preparation as graded using our new Chicago Bowel Preparation Scale (BPS) (Adventist Midwest Region Institutional Review Board, AMH 2010-01-80; ClinicalTrials.gov NCT01063049). Chicago BPS total score is ranges from 0 (very poor) to 36 (outstanding). Modified Chicago BPS total score is ranges from 0 (very poor) to 33 (outstanding). Chicago BPS Fluid score is ranges from 0 (dry) to 3 (wet).
measure: Boston Bowel Preparation Scale
time frame: At completion of colonoscopy - day 1
description: The quality of the colon preparation as graded using Boston Bowel Preparation total scores is range from 0 (very poor) to 9 (outstanding).
measure: Adequate/Inadequate Scale
time frame: At completion of colonoscopy - day 1
description: The cleanliness of the colon as rated by the gastroenterologist using an adequate/inadequate scale where an adequate preparation is defined as being able to see at least 95% of the mucosa of the colon after washing and suctioning; otherwise, the preparation is rated as inadequate.
arm group label: MiraLAX 306 g (Day-Prior)
arm group type: Active Comparator
description: MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM
arm group label: MiraLAX 357 g (Day-Prior)
arm group type: Experimental
description: MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.
arm group label: MiraLAX 306 g (Split-Dose)
arm group type: Experimental
description: MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.
arm group label: MoviPrep (Split-Dose)
arm group type: Active Comparator
description: MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.
arm group label: SUPREP (Split-Dose)
arm group type: Active Comparator
description: SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.
intervention type: Drug
intervention name: MiraLAX
description: MiraLAX consumed as described in each arm.
arm group label: MiraLAX 306 g (Day-Prior)
arm group label: MiraLAX 306 g (Split-Dose)
arm group label: MiraLAX 357 g (Day-Prior)
other name: PEG-3350
intervention type: Other
intervention name: Gatorade
description: Gatorade consumed as described in each arm.
arm group label: MiraLAX 306 g (Day-Prior)
arm group label: MiraLAX 306 g (Split-Dose)
arm group label: MiraLAX 357 g (Day-Prior)
intervention type: Drug
intervention name: MoviPrep
description: MoviPrep consumed as described in each arm.
arm group label: MoviPrep (Split-Dose)
intervention type: Drug
intervention name: SUPREP
description: SUPREP consumed as described in each arm.
arm group label: SUPREP (Split-Dose)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David Gerard, MD
role: Principal Investigator
affiliation: Gastroenterology Services, Ltd.
facility: 
country: United States
citation: Gerard DP, Foster DB, Holden JL, Kang J, Raiser MW. Clinical Trial of 1000 Subjects Randomized to 5 Low-Volume Bowel Preparations for Colonoscopy and Their Acceptance of Split-Dose Bowel Preparations. J Clin Gastroenterol. 2017 Jul;51(6):512-521. doi: 10.1097/MCG.0000000000000575.
PMID: 27433812
responsible party type: Sponsor
mesh term: Polyethylene glycol 3350
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 