<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/NCT02189850</url>
  </required_header>
  <id_info>
    <org_study_id>BLI800-501</org_study_id>
    <nct_id>NCT02189850</nct_id>
  </id_info>
  <brief_title>Efficacy, Safety and Tolerability of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Braintree Laboratories</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Braintree Laboratories</source>
  <brief_summary>
    <textblock>
      The purpose o this study is to evaluate the safety, tolerance and efficacy of BLI800 as a&#xD;
      bowel preparation prior to colonoscopy in pediatric patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>Phase 2</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>% of Subjects With Successful Preparation Rated by Colonoscopist on a 4 Point Scale (1=Poor to 4 = Excellent)</measure>
    <time_frame>2 days</time_frame>
    <description>Successful Preparation, defined as a colonoscopy rated as Excellent or Good by the blinded endoscopist.&#xD;
Poor: Large amounts of fecal residue, additional bowel preparation required; Fair: Enough feces even after washing and suctioning to prevent clear visualization of the entire colonic mucosa; Good: Feces and fluid requiring washing and suctioning, but still achieves clear visualization of the entire colonic mucosa; Excellent: No more than small bits of feces/fluid which can be suctioned easily; achieves clear visualization of the entire colonic mucosa</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Colonoscopy</condition>
  <arm_group>
    <arm_group_label>BLI800 - Dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BLI800 oral solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BLI800 - Dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BLI800 oral solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BLI800 - Dose 1</intervention_name>
    <description>BLI800 oral solution</description>
    <arm_group_label>BLI800 - Dose 1</arm_group_label>
    <other_name>BLI800</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BLI800 - Dose 2</intervention_name>
    <description>BLI800 oral solution</description>
    <arm_group_label>BLI800 - Dose 2</arm_group_label>
    <other_name>BLI800</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Male or female between the ages of 12 to 17&#xD;
&#xD;
          -  Weight more than 40kg&#xD;
&#xD;
          -  Undergoing colonoscopy for routinely accepted indications&#xD;
&#xD;
          -  If female, and of child-bearing potential, subject must use an acceptable form of&#xD;
             birth control or remain abstinent for the duration of the study.&#xD;
&#xD;
          -  Negative pregnancy test at screening, if applicable&#xD;
&#xD;
          -  In the Investigator's judgment, caregiver is mentally competent to provide informed&#xD;
             consent for their child to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with known or suspected ileus, impaction, severe ulcerative colitis, acute&#xD;
             peritonitis, gastrointestinal obstruction, gastric retention (gastroparesis), bowel&#xD;
             perforation, toxic colitis or megacolon.&#xD;
&#xD;
          -  Subjects who had previous significant gastrointestinal surgeries.&#xD;
&#xD;
          -  Subjects with increased risk of bowel perforation, including connective tissue&#xD;
             disorders, toxic dilation of the bowel or recent bowel surgery.&#xD;
&#xD;
          -  Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with&#xD;
             clinically significant electrolyte abnormalities based on Visit 1 laboratory results&#xD;
&#xD;
          -  Subjects with bleeding disorders and/or impaired platelet function, or neutropenia.&#xD;
&#xD;
          -  Subjects with a prior history of renal, liver or cardiac insufficiency&#xD;
&#xD;
          -  Subjects required to take any other oral medication within 3 hours of dosing until&#xD;
             completion of both doses.&#xD;
&#xD;
          -  Subjects with impaired consciousness that predisposes them to pulmonary aspiration.&#xD;
&#xD;
          -  Subjects with tendency for nausea and/or vomiting, or that have known swallowing&#xD;
             disorders.&#xD;
&#xD;
          -  Subjects for whom intake of substances is likely to affect gastrointestinal motility&#xD;
             or urinary flow rate.&#xD;
&#xD;
          -  Subjects undergoing colonoscopy for foreign body removal and/or decompression.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Arkansas Children's Hospital Research Institute</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Center for Digestive Health Care</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delta Research Partners</name>
      <address>
        <city>Bastrop</city>
        <state>Louisiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastrointestinal Associates</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Buffalo Pediatric Associates</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <results_first_submitted>February 2, 2021</results_first_submitted>
  <results_first_submitted_qc>February 22, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 15, 2021</results_first_posted>
  <disposition_first_submitted>July 18, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>July 18, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">July 19, 2016</disposition_first_posted>
  <last_update_submitted>February 22, 2021</last_update_submitted>
  <last_update_submitted_qc>February 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>colonoscopy</keyword>
  <keyword>pediatric</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>BLI800 - Dose 1</title>
          <description>BLI800 oral solution&#xD;
BLI800 - Dose 1: BLI800 oral solution (6 oz)</description>
        </group>
        <group group_id="P2">
          <title>BLI800 - Dose 2</title>
          <description>BLI800 oral solution&#xD;
BLI800 - Dose 2: BLI800 oral solution (4.5 oz)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population - all subjects that took preparation.</population>
      <group_list>
        <group group_id="B1">
          <title>BLI800 - Dose 1</title>
          <description>BLI800 oral solution&#xD;
BLI800 - Dose 1: BLI800 oral solution (6 oz)</description>
        </group>
        <group group_id="B2">
          <title>BLI800 - Dose 2</title>
          <description>BLI800 oral solution&#xD;
BLI800 - Dose 2: BLI800 oral solution (4.5 oz)</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="16"/>
            <count group_id="B2" value="13"/>
            <count group_id="B3" value="29"/>
          </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="15.2" spread="1.2"/>
                    <measurement group_id="B2" value="15.8" spread="1.4"/>
                    <measurement group_id="B3" value="15.5" spread="1.3"/>
                  </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="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </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="16"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Puburtal Staging</title>
          <description>Pubertal Tanner Staging from I (prepubertal) to V (adult genitalia)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>I</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>III</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IV</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>V</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>% of Subjects With Successful Preparation Rated by Colonoscopist on a 4 Point Scale (1=Poor to 4 = Excellent)</title>
        <description>Successful Preparation, defined as a colonoscopy rated as Excellent or Good by the blinded endoscopist.&#xD;
Poor: Large amounts of fecal residue, additional bowel preparation required; Fair: Enough feces even after washing and suctioning to prevent clear visualization of the entire colonic mucosa; Good: Feces and fluid requiring washing and suctioning, but still achieves clear visualization of the entire colonic mucosa; Excellent: No more than small bits of feces/fluid which can be suctioned easily; achieves clear visualization of the entire colonic mucosa</description>
        <time_frame>2 days</time_frame>
        <population>Efficacy population</population>
        <group_list>
          <group group_id="O1">
            <title>BLI800 - Dose 1</title>
            <description>BLI800 oral solution&#xD;
BLI800 - Dose 1: BLI800 oral solution (6 oz)</description>
          </group>
          <group group_id="O2">
            <title>BLI800 - Dose 2</title>
            <description>BLI800 oral solution&#xD;
BLI800 - Dose 2: BLI800 oral solution (4.5 oz)</description>
          </group>
        </group_list>
        <measure>
          <title>% of Subjects With Successful Preparation Rated by Colonoscopist on a 4 Point Scale (1=Poor to 4 = Excellent)</title>
          <description>Successful Preparation, defined as a colonoscopy rated as Excellent or Good by the blinded endoscopist.&#xD;
Poor: Large amounts of fecal residue, additional bowel preparation required; Fair: Enough feces even after washing and suctioning to prevent clear visualization of the entire colonic mucosa; Good: Feces and fluid requiring washing and suctioning, but still achieves clear visualization of the entire colonic mucosa; Excellent: No more than small bits of feces/fluid which can be suctioned easily; achieves clear visualization of the entire colonic mucosa</description>
          <population>Efficacy population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.923</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>BLI800 - Dose 1</title>
          <description>BLI800 oral solution&#xD;
BLI800 - Dose 1: BLI800 oral solution (6 oz)</description>
        </group>
        <group group_id="E2">
          <title>BLI800 - Dose 2</title>
          <description>BLI800 oral solution&#xD;
BLI800 - Dose 2: BLI800 oral solution (4.5 oz)</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="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="13" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="16"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="16"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Abdominal tenderness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Anal fissure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Anorectal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Eructation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="16"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Rectal hemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Helicobacter infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Bacterial test</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Protein urine present</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Urinary casts</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysmenorrhea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The sole disclosure restriction which sponsor imposes on the PI is a sixty (60) day limited restriction in order to the protect potentially proprietary information which may be patentable</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Head of R&amp;D, Gastroenterology</name_or_title>
      <organization>Braintree Laboratories, Inc.</organization>
      <phone>781-843-2202</phone>
      <email>studydirector@sebelapharma.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/NCT02189850
org study id: BLI800-501
nct id: NCT02189850
lead sponsor: 
The purpose o this study is to evaluate the safety, tolerance and efficacy of BLI800 as a
      bowel preparation prior to colonoscopy in pediatric patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: % of Subjects With Successful Preparation Rated by Colonoscopist on a 4 Point Scale (1=Poor to 4 = Excellent)
time frame: 2 days
description: Successful Preparation, defined as a colonoscopy rated as Excellent or Good by the blinded endoscopist.
Poor: Large amounts of fecal residue, additional bowel preparation required; Fair: Enough feces even after washing and suctioning to prevent clear visualization of the entire colonic mucosa; Good: Feces and fluid requiring washing and suctioning, but still achieves clear visualization of the entire colonic mucosa; Excellent: No more than small bits of feces/fluid which can be suctioned easily; achieves clear visualization of the entire colonic mucosa
arm group label: BLI800 - Dose 1
arm group type: Experimental
description: BLI800 oral solution
arm group label: BLI800 - Dose 2
arm group type: Experimental
description: BLI800 oral solution
intervention type: Drug
intervention name: BLI800 - Dose 1
description: BLI800 oral solution
arm group label: BLI800 - Dose 1
other name: BLI800
intervention type: Drug
intervention name: BLI800 - Dose 2
description: BLI800 oral solution
arm group label: BLI800 - Dose 2
other name: BLI800
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 