<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/NCT01695863</url>
  </required_header>
  <id_info>
    <org_study_id>11042705</org_study_id>
    <nct_id>NCT01695863</nct_id>
  </id_info>
  <brief_title>Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep</brief_title>
  <official_title>Phase 4 of Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rush University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rush University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be comparing patient satisfaction, efficacy comparing miralax with gatorade&#xD;
      versus Movi Prep for outpatient colonoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study is the purpose of evaluating patient satisfaction and at the same time efficacy of the&#xD;
      bowel regimen in cleansing the colon&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">November 2012</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>Screening</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS)</measure>
    <time_frame>Outcome BBPS was measured during surgery for endoscopist #1 and nurse raters and post-operatively (at any time before the end of the study) by endoscopist #2</time_frame>
    <description>To assess the bowel prep efficacy in cleansing the colon for colonoscopy - Scale used is the Boston Bowel Preparation Scale (BBPS), Integer Scale from 0-3, where 3 indicated the best outcome and 0 the worst. The BBPS was estimated during the procedure (Colonoscopy) by an endoscopist and a nurse and retrospectively by a second endoscopist postoperatively. Scores were averaged by for each subject by location (Right colon, Transverse colon, and Left colon) and then for each group/arm by location.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Renal Function Pre and Post Bowel Prep (mg/dL)</measure>
    <time_frame>Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure).</time_frame>
    <description>Changes in electrolytes pre and post bowel preparation administration. Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure). Change is electrolytes are presented as pre bowel prep value minus post bowel prep value but prior to procedure (Pre-Post). Units = Milligrams/deciLiter (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal Function Pre and Post Bowel Prep - Continued (mmol/L)</measure>
    <time_frame>Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure).</time_frame>
    <description>Changes in electrolytes pre and post bowel preparation administration. Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure). Change is electrolytes are presented as pre bowel prep value minus post bowel prep value, but prior to procedure (Pre-Post). Units=Millimoles per Liter (mmol/L)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Non-Serious Adverse Events on Self Report Scale</measure>
    <time_frame>During Bowel Preparation (Pre-Operative)</time_frame>
    <description>Non-Serious Adverse Events on self report scale - 5 point scale from &quot;No Complaints (0)&quot; to &quot;Very Severe (4)&quot; with 4 indicating the worst outcome and 0 the best.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>miralax</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>miralax with dulcolax and gatorade efficacy evaluated by colonoscopy and patient satisfaction evaluated by patient questionnaire</description>
  </arm_group>
  <arm_group>
    <arm_group_label>moviprep split dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Efficacy of split dose moviprep on cleansing colon for colonoscopy and patient satisfaction with the regimen</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>comparing 2 drugs on their effect on the bowel preparation for colonoscopy</intervention_name>
    <description>the effects of the drug on the colon preparation for colonoscopy</description>
    <arm_group_label>miralax</arm_group_label>
    <arm_group_label>moviprep split dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  outpatient colonoscopy for screening for other Gi related problems&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe Congestive Heart Failure (CHF),&#xD;
&#xD;
          -  Chronic Kidney Disease (CKD),&#xD;
&#xD;
          -  less than age 18 or more than 80 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maqsood A Khan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rush University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ali Keshavarzian, MD</last_name>
    <role>Study Chair</role>
    <affiliation>RUMC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael D Brown, MD</last_name>
    <role>Study Director</role>
    <affiliation>RUMC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John losurdo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rush University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rush Unversity Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://rush.edu</url>
    <description>rush university medical center website</description>
  </link>
  <reference>
    <citation>Rex DK, Imperiale TF, Latinovich DR, Bratcher LL. Impact of bowel preparation on efficiency and cost of colonoscopy. Am J Gastroenterol. 2002 Jul;97(7):1696-700. doi: 10.1111/j.1572-0241.2002.05827.x.</citation>
    <PMID>12135020</PMID>
  </reference>
  <reference>
    <citation>Hookey LC, Vanner S. A review of current issues underlying colon cleansing before colonoscopy. Can J Gastroenterol. 2007 Feb;21(2):105-11. doi: 10.1155/2007/634125.</citation>
    <PMID>17299615</PMID>
  </reference>
  <reference>
    <citation>DiPalma JA, Wolff BG, Meagher A, Cleveland Mv. Comparison of reduced volume versus four liters sulfate-free electrolyte lavage solutions for colonoscopy colon cleansing. Am J Gastroenterol. 2003 Oct;98(10):2187-91. doi: 10.1111/j.1572-0241.2003.07690.x.</citation>
    <PMID>14572566</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <results_first_submitted>May 2, 2023</results_first_submitted>
  <results_first_submitted_qc>August 1, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 2, 2023</results_first_posted>
  <last_update_submitted>August 1, 2023</last_update_submitted>
  <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Miralax with gatorade and dulcolax</keyword>
  <keyword>Movi pre</keyword>
  <keyword>Patient satisfaction and efficacy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 150 patients were recruited and randomized to 75 patients in each arm. Of these, 128 patients arrived for the colonoscopy; therefore eligible to enter the final analysis.</recruitment_details>
      <pre_assignment_details>To be able to enter a recruited patient into analysis, the consented patient must complete their colonoscopy. Of the 150 consented patients, 128 completed their colonoscopy while the remaining 22 did not. Those who did not complete their colonoscopy were excluded from analysis.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Miralax</title>
          <description>Miralax with Dulcolax and Gatorade given orally prior to surgery</description>
        </group>
        <group group_id="P2">
          <title>Moviprep Split Dose</title>
          <description>Split dose Moviprep given orally prior to surgery</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
                <participants group_id="P2" count="66"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
                <participants group_id="P2" count="66"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Miralax</title>
          <description>Miralax with Dulcolax and Gatorade given prior to surgery.</description>
        </group>
        <group group_id="B2">
          <title>Moviprep Split Dose</title>
          <description>Split dose Moviprep on cleansing colon given prior to surgery</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="62"/>
            <count group_id="B2" value="66"/>
            <count group_id="B3" value="128"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Age &gt; 18 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="128"/>
                  </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="36"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS)</title>
        <description>To assess the bowel prep efficacy in cleansing the colon for colonoscopy - Scale used is the Boston Bowel Preparation Scale (BBPS), Integer Scale from 0-3, where 3 indicated the best outcome and 0 the worst. The BBPS was estimated during the procedure (Colonoscopy) by an endoscopist and a nurse and retrospectively by a second endoscopist postoperatively. Scores were averaged by for each subject by location (Right colon, Transverse colon, and Left colon) and then for each group/arm by location.</description>
        <time_frame>Outcome BBPS was measured during surgery for endoscopist #1 and nurse raters and post-operatively (at any time before the end of the study) by endoscopist #2</time_frame>
        <population>A few of the outcomes had Missing data since the evaluations were not complete for specific locations by the clinical personnel.</population>
        <group_list>
          <group group_id="O1">
            <title>Miralax</title>
            <description>Miralax with Dulcolax and Gatorade efficacy evaluated by colonoscopy</description>
          </group>
          <group group_id="O2">
            <title>Moviprep Split Dose</title>
            <description>Efficacy of split dose moviprep on cleansing colon for colonoscopy</description>
          </group>
        </group_list>
        <measure>
          <title>Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS)</title>
          <description>To assess the bowel prep efficacy in cleansing the colon for colonoscopy - Scale used is the Boston Bowel Preparation Scale (BBPS), Integer Scale from 0-3, where 3 indicated the best outcome and 0 the worst. The BBPS was estimated during the procedure (Colonoscopy) by an endoscopist and a nurse and retrospectively by a second endoscopist postoperatively. Scores were averaged by for each subject by location (Right colon, Transverse colon, and Left colon) and then for each group/arm by location.</description>
          <population>A few of the outcomes had Missing data since the evaluations were not complete for specific locations by the clinical personnel.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Right Colon</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.79" spread="0.72"/>
                    <measurement group_id="O2" value="2.33" spread=".89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Transverse Colon</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.06" spread="0.79"/>
                    <measurement group_id="O2" value="2.45" spread="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Left Colon</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.24" spread="0.76"/>
                    <measurement group_id="O2" value="2.46" spread="0.70"/>
                  </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>
            <groups_desc>Right Colon</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>.54</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.269</ci_lower_limit>
            <ci_upper_limit>0.816</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Transverse Colon</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.005</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.122</ci_lower_limit>
            <ci_upper_limit>0.655</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Left Colon</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.08</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.029</ci_lower_limit>
            <ci_upper_limit>0.484</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Renal Function Pre and Post Bowel Prep (mg/dL)</title>
        <description>Changes in electrolytes pre and post bowel preparation administration. Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure). Change is electrolytes are presented as pre bowel prep value minus post bowel prep value but prior to procedure (Pre-Post). Units = Milligrams/deciLiter (mg/dL)</description>
        <time_frame>Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Miralax</title>
            <description>Miralax with Dulcolax and Gatorade - Given Orally</description>
          </group>
          <group group_id="O2">
            <title>Moviprep Split Dose</title>
            <description>Split dose Moviprep - Given Orally</description>
          </group>
        </group_list>
        <measure>
          <title>Renal Function Pre and Post Bowel Prep (mg/dL)</title>
          <description>Changes in electrolytes pre and post bowel preparation administration. Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure). Change is electrolytes are presented as pre bowel prep value minus post bowel prep value but prior to procedure (Pre-Post). Units = Milligrams/deciLiter (mg/dL)</description>
          <units>Milligram per deciLiter (mg/dL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Calcium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18" spread=".53"/>
                    <measurement group_id="O2" value="0.02" spread=".53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.41" spread="45.44"/>
                    <measurement group_id="O2" value="3.44" spread="45.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood Urea Nitrogen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.44" spread="4.72"/>
                    <measurement group_id="O2" value="3.00" spread="4.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.14"/>
                    <measurement group_id="O2" value="-0.02" spread="0.14"/>
                  </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>
            <groups_desc>Calcium</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.093</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.16</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Glucose</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.801</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.03</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Blood Urea Nitrogen</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.599</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.44</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Creatinine</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.696</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.01</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Sodium</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.042</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.19</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Potassium</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.596</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.07</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Chloride</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.107</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.98</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Bicarbonate</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.351</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.71</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Non-Serious Adverse Events on Self Report Scale</title>
        <description>Non-Serious Adverse Events on self report scale - 5 point scale from &quot;No Complaints (0)&quot; to &quot;Very Severe (4)&quot; with 4 indicating the worst outcome and 0 the best.</description>
        <time_frame>During Bowel Preparation (Pre-Operative)</time_frame>
        <population>These are self-report measures and not all subject submitted or complete the self report measures. Of 62 in the Miralax condition 43 retuned the self-report questionnaire (19 did not) and of 66 in the Moviprep condition 51 returned the self-report questionnaire (15 did not).</population>
        <group_list>
          <group group_id="O1">
            <title>Miralax</title>
            <description>miralax with dulcolax and gatorade</description>
          </group>
          <group group_id="O2">
            <title>Moviprep Split Dose</title>
            <description>Split dose Moviprep given orally</description>
          </group>
        </group_list>
        <measure>
          <title>Non-Serious Adverse Events on Self Report Scale</title>
          <description>Non-Serious Adverse Events on self report scale - 5 point scale from &quot;No Complaints (0)&quot; to &quot;Very Severe (4)&quot; with 4 indicating the worst outcome and 0 the best.</description>
          <population>These are self-report measures and not all subject submitted or complete the self report measures. Of 62 in the Miralax condition 43 retuned the self-report questionnaire (19 did not) and of 66 in the Moviprep condition 51 returned the self-report questionnaire (15 did not).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Nausea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3590" spread="0.77"/>
                    <measurement group_id="O2" value="0.3152" spread="0.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2821" spread="0.85"/>
                    <measurement group_id="O2" value="0.0000" spread="0.0000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bloating</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6667" spread="0.89"/>
                    <measurement group_id="O2" value="0.4565" spread="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal pain or cramping</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.359" spread="0.66"/>
                    <measurement group_id="O2" value="0.3043" spread="0.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ability to complete entire prep</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.878" spread="0.39"/>
                    <measurement group_id="O2" value="1.8511" spread="0.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difficulty/Inconvenience in completing prep</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6098" spread="0.80"/>
                    <measurement group_id="O2" value="0.6596" spread="0.75"/>
                  </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>
            <groups_desc>Nausea</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.772</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.0438</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Vomiting</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.028</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.2821</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Bloating</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.235</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.2102</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Abdominal pain or cramping</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.707</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.0547</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Ability to complete entire prep</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.773</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.0269</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difficulty/Inconvenience in completing prep</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.766</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.0498</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Renal Function Pre and Post Bowel Prep - Continued (mmol/L)</title>
        <description>Changes in electrolytes pre and post bowel preparation administration. Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure). Change is electrolytes are presented as pre bowel prep value minus post bowel prep value, but prior to procedure (Pre-Post). Units=Millimoles per Liter (mmol/L)</description>
        <time_frame>Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Miralax</title>
            <description>Miralax with Dulcolax and Gatorade - Given Orally</description>
          </group>
          <group group_id="O2">
            <title>Moviprep Split Dose</title>
            <description>Split dose Moviprep - Given Orally</description>
          </group>
        </group_list>
        <measure>
          <title>Renal Function Pre and Post Bowel Prep - Continued (mmol/L)</title>
          <description>Changes in electrolytes pre and post bowel preparation administration. Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure). Change is electrolytes are presented as pre bowel prep value minus post bowel prep value, but prior to procedure (Pre-Post). Units=Millimoles per Liter (mmol/L)</description>
          <units>Millimoles per Liter (mmol/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sodium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.27" spread="3.28"/>
                    <measurement group_id="O2" value="-0.92" spread="3.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.18" spread="0.74"/>
                    <measurement group_id="O2" value="-0.11" spread="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.54" spread="3.41"/>
                    <measurement group_id="O2" value="-0.44" spread="3.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bicarbonate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.43" spread="4.29"/>
                    <measurement group_id="O2" value="2.14" spread="4.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>8 Months for Adverse Events. For side effects, &quot;Other (Not Including Serious) Adverse Events&quot;, the questionnaire for bowl prep solution was given preoperatively and collected before surgery (3 days before surgery to day of surgery).</time_frame>
      <desc>Adverse events are reported here. Side effects were reported on a self-report scale in the outcomes section and as such the sample sizes were smaller for both groups since some subjects did not complete the questionnaire.&#xD;
Of 62 in the Miralax condition 43 retuned the self-report questionnaire (19 did not) and of 66 in the Moviprep condition 51 returned the self-report questionnaire (15 did not).</desc>
      <group_list>
        <group group_id="E1">
          <title>Miralax</title>
          <description>miralax with dulcolax and gatorade Condition</description>
        </group>
        <group group_id="E2">
          <title>Moviprep Split Dose</title>
          <description>Split dose moviprep Condition</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="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="66"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="66"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <description>Likert score &gt;0 on 0-4 scale, 0 (No Complaints) to 4 (Very Severe)</description>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <description>Likert score &gt;0 on 0-4 scale, 0 (No Complaints) to 4 (Very Severe)</description>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Bloating</sub_title>
                <description>Likert score &gt;0 on 0-4 scale, 0 (No Complaints) to 4 (Very Severe)</description>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Abdominal Pain or Cramping</sub_title>
                <description>Likert score &gt;0 on 0-4 scale, 0 (No Complaints) to 4 (Very Severe)</description>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Inability to Complete Prep</sub_title>
                <description>Likert score &gt;0 on 0-4 scale, 0 (No Complaints) to 4 (Very Severe)</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Difficulty in Completing Prep</sub_title>
                <description>Likert score &gt;0 on 0-4 scale, 0 (No Complaints) to 4 (Very Severe)</description>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="51"/>
              </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>
    <limitations_and_caveats>No systematic recording of incidence for non-serious adverse events were collected by study personnel or subjects, so details on event occurrence cannot be provided. Adverse events on a self-report scale of severity are recorded the table names: &quot;Non-Serious Adverse Events on Self Report Scale&quot; and provide an index of the perceived impact of non-serious adverse events on the subjects.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Maqsood Khan MD FACG</name_or_title>
      <organization>Aurora Gastroenterology, West Allis WI</organization>
      <phone>414-328-8750</phone>
      <email>mkhangi@yahoo.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/NCT01695863
org study id: 11042705
nct id: NCT01695863
lead sponsor: 
has dmc: Yes
This study will be comparing patient satisfaction, efficacy comparing miralax with gatorade
      versus Movi Prep for outpatient colonoscopy.
Study is the purpose of evaluating patient satisfaction and at the same time efficacy of the
      bowel regimen in cleansing the colon
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Investigator)
measure: Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS)
time frame: Outcome BBPS was measured during surgery for endoscopist #1 and nurse raters and post-operatively (at any time before the end of the study) by endoscopist #2
description: To assess the bowel prep efficacy in cleansing the colon for colonoscopy - Scale used is the Boston Bowel Preparation Scale (BBPS), Integer Scale from 0-3, where 3 indicated the best outcome and 0 the worst. The BBPS was estimated during the procedure (Colonoscopy) by an endoscopist and a nurse and retrospectively by a second endoscopist postoperatively. Scores were averaged by for each subject by location (Right colon, Transverse colon, and Left colon) and then for each group/arm by location.
measure: Renal Function Pre and Post Bowel Prep (mg/dL)
time frame: Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure).
description: Changes in electrolytes pre and post bowel preparation administration. Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure). Change is electrolytes are presented as pre bowel prep value minus post bowel prep value but prior to procedure (Pre-Post). Units = Milligrams/deciLiter (mg/dL)
measure: Renal Function Pre and Post Bowel Prep - Continued (mmol/L)
time frame: Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure).
description: Changes in electrolytes pre and post bowel preparation administration. Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure). Change is electrolytes are presented as pre bowel prep value minus post bowel prep value, but prior to procedure (Pre-Post). Units=Millimoles per Liter (mmol/L)
measure: Non-Serious Adverse Events on Self Report Scale
time frame: During Bowel Preparation (Pre-Operative)
description: Non-Serious Adverse Events on self report scale - 5 point scale from "No Complaints (0)" to "Very Severe (4)" with 4 indicating the worst outcome and 0 the best.
arm group label: miralax
arm group type: Experimental
description: miralax with dulcolax and gatorade efficacy evaluated by colonoscopy and patient satisfaction evaluated by patient questionnaire
arm group label: moviprep split dose
arm group type: Experimental
description: Efficacy of split dose moviprep on cleansing colon for colonoscopy and patient satisfaction with the regimen
intervention type: Drug
intervention name: comparing 2 drugs on their effect on the bowel preparation for colonoscopy
description: the effects of the drug on the colon preparation for colonoscopy
arm group label: miralax
arm group label: moviprep split dose
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maqsood A Khan, MD
role: Principal Investigator
affiliation: Rush University Medical Center
last name: Ali Keshavarzian, MD
role: Study Chair
affiliation: RUMC
last name: Michael D Brown, MD
role: Study Director
affiliation: RUMC
last name: John losurdo, MD
role: Principal Investigator
affiliation: Rush University Medical Center
facility: 
country: United States
url: http://rush.edu
description: rush university medical center website
citation: Rex DK, Imperiale TF, Latinovich DR, Bratcher LL. Impact of bowel preparation on efficiency and cost of colonoscopy. Am J Gastroenterol. 2002 Jul;97(7):1696-700. doi: 10.1111/j.1572-0241.2002.05827.x.
PMID: 12135020
citation: Hookey LC, Vanner S. A review of current issues underlying colon cleansing before colonoscopy. Can J Gastroenterol. 2007 Feb;21(2):105-11. doi: 10.1155/2007/634125.
PMID: 17299615
citation: DiPalma JA, Wolff BG, Meagher A, Cleveland Mv. Comparison of reduced volume versus four liters sulfate-free electrolyte lavage solutions for colonoscopy colon cleansing. Am J Gastroenterol. 2003 Oct;98(10):2187-91. doi: 10.1111/j.1572-0241.2003.07690.x.
PMID: 14572566
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: No systematic recording of incidence for non-serious adverse events were collected by study personnel or subjects, so details on event occurrence cannot be provided. Adverse events on a self-report scale of severity are recorded the table names: "Non-Serious Adverse Events on Self Report Scale" and provide an index of the perceived impact of non-serious adverse events on the subjects.
point of contact: 