<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/NCT04446299</url>
  </required_header>
  <id_info>
    <org_study_id>BLI4900-301</org_study_id>
    <nct_id>NCT04446299</nct_id>
  </id_info>
  <brief_title>Study 301: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy</brief_title>
  <official_title>A Safety and Efficacy Comparison of BLI4900 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 purpose of this study is to compare the safety and efficacy of BLI4900 bowel preparation&#xD;
      to an FDA-approved control as 2-day, split-dose bowel preparations prior to colonoscopy in&#xD;
      adult patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 13, 2020</start_date>
  <completion_date type="Actual">January 22, 2021</completion_date>
  <primary_completion_date type="Actual">December 22, 2020</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>Proportion of subjects with successful bowel preparation</measure>
    <time_frame>2 days</time_frame>
    <description>Successful bowel preparation is defined as a preparation rated as Excellent or Good by the blinded endoscopist on a 4 point scale (Excellent, Good, Fair, Poor).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">520</enrollment>
  <condition>Colonoscopy</condition>
  <arm_group>
    <arm_group_label>BLI4900</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental bowel preparation solution for oral ingestion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FDA Approved Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>FDA approved bowel preparation solution for oral ingestion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bowel Prep</intervention_name>
    <description>Orally ingested liquid bowel preparation</description>
    <arm_group_label>BLI4900</arm_group_label>
    <arm_group_label>FDA Approved Control</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.&#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 inflammatory bowel disease who have a history of any bowel resection&#xD;
             (small intestine or colon), suspected active inflammation, or symptoms suggestive of&#xD;
             obstruction or known bowel stricture.&#xD;
&#xD;
          -  Subjects who had previous significant gastrointestinal surgeries.&#xD;
&#xD;
          -  Subjects who have regularly used laxatives or colon motility altering drugs in the&#xD;
             last month (i.e. more than 2-3 times per week) and/or laxative use within 72 hours&#xD;
             prior to administration of the preparation&#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.&#xD;
&#xD;
          -  Subjects with uncontrolled hypertension.&#xD;
&#xD;
          -  Subjects taking antibiotics within 7 days of colonoscopy.&#xD;
&#xD;
          -  Subjects with severe renal, hepatic or cardiac insufficiency.&#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 taking tricyclic antidepressants.&#xD;
&#xD;
          -  Subjects using drugs of abuse, including abused prescription medications.&#xD;
&#xD;
          -  Subjects who are withdrawing from alcohol or benzodiazepines.&#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</last_name>
    <role>Study Director</role>
    <affiliation>Braintree Laboratories / Sebela Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>301 Research Site 18</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>38501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>301 Research Site 24</name>
      <address>
        <city>Sun City</city>
        <state>Arizona</state>
        <zip>85351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>301 Research Site 7</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>301 Research Site 16</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>301 Research Site 12</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>301 Research Site 9</name>
      <address>
        <city>Palm Harbor</city>
        <state>Florida</state>
        <zip>34684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>301 Research Site 4</name>
      <address>
        <city>Palmetto Bay</city>
        <state>Florida</state>
        <zip>33157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>301 Research Site 26</name>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <zip>32127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>301 Research Site 14</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33709</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>301 Research Site 25</name>
      <address>
        <city>Sunrise</city>
        <state>Florida</state>
        <zip>33351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>301 Research Site 2</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>301 Research Site 10</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>301 Research Site 3</name>
      <address>
        <city>Monroe</city>
        <state>Louisiana</state>
        <zip>71201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>301 Research Site 17</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>301 Research Site 11</name>
      <address>
        <city>Flowood</city>
        <state>Mississippi</state>
        <zip>39232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>301 Research Site 13</name>
      <address>
        <city>Chesterfield</city>
        <state>Missouri</state>
        <zip>48047</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>301 Research Site 19</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>301 Research Site 15</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>301 Research Site 5</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>301 Research Site 23</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>301 Research Site 6</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>301 Research Site 21</name>
      <address>
        <city>Mentor</city>
        <state>Ohio</state>
        <zip>44060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>301 Research Site 20</name>
      <address>
        <city>Hixson</city>
        <state>Tennessee</state>
        <zip>37434</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>301 Research Site 1</name>
      <address>
        <city>Ogden</city>
        <state>Utah</state>
        <zip>84405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>301 Research Site 22</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>March 11, 2021</last_update_submitted>
  <last_update_submitted_qc>March 11, 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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04446299
org study id: BLI4900-301
nct id: NCT04446299
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to compare the safety and efficacy of BLI4900 bowel preparation
      to an FDA-approved control 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: Proportion of subjects with successful bowel preparation
time frame: 2 days
description: Successful bowel preparation is defined as a preparation rated as Excellent or Good by the blinded endoscopist on a 4 point scale (Excellent, Good, Fair, Poor).
arm group label: BLI4900
arm group type: Experimental
description: Experimental bowel preparation solution for oral ingestion
arm group label: FDA Approved Control
arm group type: Active Comparator
description: FDA approved bowel preparation solution for oral ingestion
intervention type: Drug
intervention name: Bowel Prep
description: Orally ingested liquid bowel preparation
arm group label: BLI4900
arm group label: FDA Approved Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: John McGowan
role: Study Director
affiliation: Braintree Laboratories / Sebela Pharmaceuticals
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No