<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/NCT03261960</url>
  </required_header>
  <id_info>
    <org_study_id>BLI4700-302</org_study_id>
    <nct_id>NCT03261960</nct_id>
  </id_info>
  <brief_title>A Safety and Efficacy Comparison of BLI4700 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy</brief_title>
  <official_title>A Safety and Efficacy Comparison of BLI4700 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Braintree Laboratories</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Braintree Laboratories</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to compare the safety and efficacy of BLI4700 bowel&#xD;
      preparation to an FDA-approved bowel preparation as 2-day, split-dose bowel preparations&#xD;
      prior to colonoscopy in adult patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 8, 2017</start_date>
  <completion_date type="Actual">March 26, 2018</completion_date>
  <primary_completion_date type="Actual">March 26, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number and Percentage of Subjects With Successful Bowel Cleansing</measure>
    <time_frame>Day of colonoscopy</time_frame>
    <description>% of subjects with successful bowel preparation rated by colonoscopist on a 4 point scale (1=poor to 4=excellent)</description>
  </primary_outcome>
  <other_outcome>
    <measure>Abdominal Pain (Solicited Reports)</measure>
    <time_frame>2 days</time_frame>
    <description>Percentage of patients who reported abdominal pain (with associated severity) when directly queried by study personnel, out of all patients that reported that event.</description>
  </other_outcome>
  <other_outcome>
    <measure>Abdominal Distension (Solicited Reports)</measure>
    <time_frame>2 days</time_frame>
    <description>Percentage of patients who reported abdominal distension (with associated severity) when directly queried by study personnel, out of all patients that reported that event.</description>
  </other_outcome>
  <other_outcome>
    <measure>Nausea (Solicited Reports)</measure>
    <time_frame>2 days</time_frame>
    <description>Percentage of patients who reported nausea (with associated severity) when directly queried by study personnel, out of all patients that reported that event.</description>
  </other_outcome>
  <other_outcome>
    <measure>Vomiting (Solicited Reports)</measure>
    <time_frame>2 days</time_frame>
    <description>Percentage of patients who reported vomiting (with associated severity) when directly queried by study personnel, out of all patients that reported that event.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">389</enrollment>
  <condition>Colonoscopy</condition>
  <arm_group>
    <arm_group_label>Experimental Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BLI4700 Bowel Preparation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>FDA Approved Bowel Preparation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BLI4700</intervention_name>
    <description>Oral bowel preparation</description>
    <arm_group_label>Experimental Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Magnesium bowel preparation</intervention_name>
    <description>Oral bowel preparation</description>
    <arm_group_label>Control Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female outpatients who are undergoing colonoscopy for a routinely accepted&#xD;
             indication.&#xD;
&#xD;
          -  18 to 85 years of age (inclusive)&#xD;
&#xD;
          -  If female, and of child-bearing potential, is using an acceptable form of birth&#xD;
             control (hormonal birth control, IUD, double-barrier method, depot contraceptive,&#xD;
             abstinent, or vasectomized spouse).&#xD;
&#xD;
          -  Negative serum pregnancy test at screening, if applicable&#xD;
&#xD;
          -  In the Investigator's judgment, subject is mentally competent to provide informed&#xD;
             consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with known or suspected ileus, gastrointestinal obstruction, gastroparesis,&#xD;
             gastric retention, bowel perforation, toxic colitis or megacolon.&#xD;
&#xD;
          -  Subjects with ongoing severe, acute inflammatory bowel disease&#xD;
&#xD;
          -  Subjects who had previous significant gastrointestinal surgeries.&#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 taking diuretics, anti-hypertensive medications, including angiotensin&#xD;
             converting enzyme (ACE) inhibitors and Angiotensin II receptor blockers (ARBs), or&#xD;
             chronic NSAIDs, that have not been stable for 30 days. NSAID use for occasional pain&#xD;
             is not exclusionary.&#xD;
&#xD;
          -  Subjects with uncontrolled hypertension (systolic blood pressure &gt; 170 mmHg and&#xD;
             diastolic blood pressure &gt; 100 mmHg).&#xD;
&#xD;
          -  Subjects taking antibiotics within 7 days of colonoscopy.&#xD;
&#xD;
          -  Subjects with severe renal insufficiency (GFR &lt; 30 mL/min/1.73m2).&#xD;
&#xD;
          -  Subjects with known severe hepatic insufficiency (Child Pugh C)&#xD;
&#xD;
          -  Subjects with cardiac insufficiency (NYHA Functional Classifications 3 or 4).&#xD;
&#xD;
          -  Subjects with an abnormal and clinically significant physical examination or ECG&#xD;
             finding at Visit 1.&#xD;
&#xD;
          -  Subjects undergoing insulin therapy for any indication.&#xD;
&#xD;
          -  Subjects with impaired consciousness that predisposes them to pulmonary aspiration.&#xD;
&#xD;
          -  Subjects undergoing colonoscopy for foreign body removal and/or decompression.&#xD;
&#xD;
          -  Subjects who are pregnant or lactating, or intending to become pregnant during the&#xD;
             study.&#xD;
&#xD;
          -  Subjects of childbearing potential who refuse a pregnancy test.&#xD;
&#xD;
          -  Subjects allergic to any preparation component.&#xD;
&#xD;
          -  Subjects using drugs of abuse, including abused prescription medications.&#xD;
&#xD;
          -  Subjects who are withdrawing from alcohol or benzodiazepines.&#xD;
&#xD;
          -  Subjects who, in the opinion of the Investigator, should not be included in the study&#xD;
             for any reason, including inability to follow study procedures.&#xD;
&#xD;
          -  Subjects who have participated in an investigational surgical, drug, or device study&#xD;
             within the past 30 days.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John McGowan, MPH</last_name>
    <role>Study Director</role>
    <affiliation>Braintree Laboratories, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Braintree Research Site 119</name>
      <address>
        <city>Dothan</city>
        <state>Alabama</state>
        <zip>36305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Braintree Research Site 117</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Braintree Research Site 108</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Braintree Research Site 110</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Braintree Research Site 139</name>
      <address>
        <city>Palmetto Bay</city>
        <state>Florida</state>
        <zip>33157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Braintree Research Site 124</name>
      <address>
        <city>Oak Lawn</city>
        <state>Illinois</state>
        <zip>60453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Braintree Research Site 134</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Braintree Research Site 112</name>
      <address>
        <city>Chevy Chase</city>
        <state>Maryland</state>
        <zip>20815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Braintree Research Site 141</name>
      <address>
        <city>Towson</city>
        <state>Maryland</state>
        <zip>20214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Braintree Research Site 125</name>
      <address>
        <city>Chesterfield</city>
        <state>Missouri</state>
        <zip>48047</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Braintree Research Site 102</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Braintree Research Site 145</name>
      <address>
        <city>Egg Harbor Township</city>
        <state>New Jersey</state>
        <zip>08234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Braintree Research Site 114</name>
      <address>
        <city>Poughkeepsie</city>
        <state>New York</state>
        <zip>12601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Braintree Research Site 105</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Braintree Research Site 115</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Braintree Research Site 137</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Braintree Research Site 101</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Braintree Research Site 107</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Braintree Research Site 131</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Braintree Research Site 121</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <results_first_submitted>May 4, 2021</results_first_submitted>
  <results_first_submitted_qc>August 12, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 8, 2021</results_first_posted>
  <disposition_first_submitted>September 27, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>August 12, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">September 8, 2021</disposition_first_posted>
  <last_update_submitted>August 12, 2021</last_update_submitted>
  <last_update_submitted_qc>August 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 28, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/60/NCT03261960/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Experimental Arm</title>
          <description>BLI4700 Bowel Preparation&#xD;
BLI4700: Oral bowel preparation</description>
        </group>
        <group group_id="P2">
          <title>Control Arm</title>
          <description>FDA Approved Bowel Preparation&#xD;
Magnesium bowel preparation: Oral bowel preparation</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="190"/>
                <participants group_id="P2" count="199"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="176"/>
                <participants group_id="P2" count="185"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population - all patients that took preparation.</population>
      <group_list>
        <group group_id="B1">
          <title>Experimental Arm</title>
          <description>BLI4700 Bowel Preparation&#xD;
BLI4700: Oral bowel preparation</description>
        </group>
        <group group_id="B2">
          <title>Control Arm</title>
          <description>FDA Approved Bowel Preparation&#xD;
Magnesium bowel preparation: Oral bowel preparation</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="190"/>
            <count group_id="B2" value="199"/>
            <count group_id="B3" value="389"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="128"/>
                    <measurement group_id="B2" value="152"/>
                    <measurement group_id="B3" value="280"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.2" spread="11.2"/>
                    <measurement group_id="B2" value="57.3" spread="10.8"/>
                    <measurement group_id="B3" value="57.8" spread="11.0"/>
                  </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="112"/>
                    <measurement group_id="B2" value="113"/>
                    <measurement group_id="B3" value="225"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="86"/>
                    <measurement group_id="B3" value="164"/>
                  </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="19"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="171"/>
                    <measurement group_id="B2" value="183"/>
                    <measurement group_id="B3" value="354"/>
                  </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="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </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="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="177"/>
                    <measurement group_id="B2" value="183"/>
                    <measurement group_id="B3" value="360"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </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="190"/>
                    <measurement group_id="B2" value="199"/>
                    <measurement group_id="B3" value="389"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Renal Insufficiency (GFR &lt; 60)</title>
          <description>Subjects with baseline GFR &lt; 60 mL/min/1.73 m2</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetic</title>
          <description>Subjects with a medical history of diabetes</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number and Percentage of Subjects With Successful Bowel Cleansing</title>
        <description>% of subjects with successful bowel preparation rated by colonoscopist on a 4 point scale (1=poor to 4=excellent)</description>
        <time_frame>Day of colonoscopy</time_frame>
        <population>Efficacy population</population>
        <group_list>
          <group group_id="O1">
            <title>Experimental Arm</title>
            <description>BLI4700 Bowel Preparation&#xD;
BLI4700: Oral bowel preparation</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>FDA Approved Bowel Preparation&#xD;
Magnesium bowel preparation: Oral bowel preparation</description>
          </group>
        </group_list>
        <measure>
          <title>Number and Percentage of Subjects With Successful Bowel Cleansing</title>
          <description>% of subjects with successful bowel preparation rated by colonoscopist on a 4 point scale (1=poor to 4=excellent)</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="190"/>
                <count group_id="O2" value="198"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="175"/>
                    <measurement group_id="O2" value="174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority margin was set at 10%.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Abdominal Pain (Solicited Reports)</title>
        <description>Percentage of patients who reported abdominal pain (with associated severity) when directly queried by study personnel, out of all patients that reported that event.</description>
        <time_frame>2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Arm</title>
            <description>BLI4700 Bowel Preparation&#xD;
BLI4700: Oral bowel preparation</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>FDA Approved Bowel Preparation&#xD;
Magnesium bowel preparation: Oral bowel preparation</description>
          </group>
        </group_list>
        <measure>
          <title>Abdominal Pain (Solicited Reports)</title>
          <description>Percentage of patients who reported abdominal pain (with associated severity) when directly queried by study personnel, out of all patients that reported that event.</description>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="190"/>
                <count group_id="O2" value="199"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Abdominal Distension (Solicited Reports)</title>
        <description>Percentage of patients who reported abdominal distension (with associated severity) when directly queried by study personnel, out of all patients that reported that event.</description>
        <time_frame>2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Arm</title>
            <description>BLI4700 Bowel Preparation&#xD;
BLI4700: Oral bowel preparation</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>FDA Approved Bowel Preparation&#xD;
Magnesium bowel preparation: Oral bowel preparation</description>
          </group>
        </group_list>
        <measure>
          <title>Abdominal Distension (Solicited Reports)</title>
          <description>Percentage of patients who reported abdominal distension (with associated severity) when directly queried by study personnel, out of all patients that reported that event.</description>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="190"/>
                <count group_id="O2" value="199"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                    <measurement group_id="O2" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Nausea (Solicited Reports)</title>
        <description>Percentage of patients who reported nausea (with associated severity) when directly queried by study personnel, out of all patients that reported that event.</description>
        <time_frame>2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Arm</title>
            <description>BLI4700 Bowel Preparation&#xD;
BLI4700: Oral bowel preparation</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>FDA Approved Bowel Preparation&#xD;
Magnesium bowel preparation: Oral bowel preparation</description>
          </group>
        </group_list>
        <measure>
          <title>Nausea (Solicited Reports)</title>
          <description>Percentage of patients who reported nausea (with associated severity) when directly queried by study personnel, out of all patients that reported that event.</description>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="190"/>
                <count group_id="O2" value="199"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Vomiting (Solicited Reports)</title>
        <description>Percentage of patients who reported vomiting (with associated severity) when directly queried by study personnel, out of all patients that reported that event.</description>
        <time_frame>2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Arm</title>
            <description>BLI4700 Bowel Preparation&#xD;
BLI4700: Oral bowel preparation</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>FDA Approved Bowel Preparation&#xD;
Magnesium bowel preparation: Oral bowel preparation</description>
          </group>
        </group_list>
        <measure>
          <title>Vomiting (Solicited Reports)</title>
          <description>Percentage of patients who reported vomiting (with associated severity) when directly queried by study personnel, out of all patients that reported that event.</description>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="190"/>
                <count group_id="O2" value="199"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Experimental Arm</title>
          <description>BLI4700 Bowel Preparation&#xD;
BLI4700: Oral bowel preparation</description>
        </group>
        <group group_id="E2">
          <title>Control Arm</title>
          <description>FDA Approved Bowel Preparation&#xD;
Magnesium bowel preparation: Oral bowel preparation</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="190"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="190"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="199"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="190"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="199"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</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="5" subjects_at_risk="190"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="199"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Liver function test increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="190"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="199"/>
              </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/NCT03261960
org study id: BLI4700-302
nct id: NCT03261960
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The objective of this study is to compare the safety and efficacy of BLI4700 bowel
      preparation to an FDA-approved bowel preparation as 2-day, split-dose bowel preparations
      prior to colonoscopy in adult patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Number and Percentage of Subjects With Successful Bowel Cleansing
time frame: Day of colonoscopy
description: % of subjects with successful bowel preparation rated by colonoscopist on a 4 point scale (1=poor to 4=excellent)
measure: Abdominal Pain (Solicited Reports)
time frame: 2 days
description: Percentage of patients who reported abdominal pain (with associated severity) when directly queried by study personnel, out of all patients that reported that event.
measure: Abdominal Distension (Solicited Reports)
time frame: 2 days
description: Percentage of patients who reported abdominal distension (with associated severity) when directly queried by study personnel, out of all patients that reported that event.
measure: Nausea (Solicited Reports)
time frame: 2 days
description: Percentage of patients who reported nausea (with associated severity) when directly queried by study personnel, out of all patients that reported that event.
measure: Vomiting (Solicited Reports)
time frame: 2 days
description: Percentage of patients who reported vomiting (with associated severity) when directly queried by study personnel, out of all patients that reported that event.
arm group label: Experimental Arm
arm group type: Experimental
description: BLI4700 Bowel Preparation
arm group label: Control Arm
arm group type: Active Comparator
description: FDA Approved Bowel Preparation
intervention type: Drug
intervention name: BLI4700
description: Oral bowel preparation
arm group label: Experimental Arm
intervention type: Drug
intervention name: Magnesium bowel preparation
description: Oral bowel preparation
arm group label: Control Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: John McGowan, MPH
role: Study Director
affiliation: Braintree Laboratories, Inc.
facility: 
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country: United States
responsible party type: Sponsor
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 