<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/NCT03023085</url>
  </required_header>
  <id_info>
    <org_study_id>BLI4700-201</org_study_id>
    <nct_id>NCT03023085</nct_id>
  </id_info>
  <brief_title>A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects</brief_title>
  <official_title>A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel&#xD;
      preparation prior to colonoscopy in adult patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2016</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>% of subjects with successful bowel preparation</measure>
    <time_frame>Day of colonoscopy</time_frame>
    <description>% of subjects with successful bowel preparation rated by blinded colonoscopist on a 4 point scale (1=poor to 4 = excellent)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of adverse events</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Colonoscopy</condition>
  <arm_group>
    <arm_group_label>BLI4700</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BLI4700 Bowel Preparation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BLI4700</intervention_name>
    <description>BLI4700 bowel preparation</description>
    <arm_group_label>BLI4700</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted&#xD;
             indication.&#xD;
&#xD;
          2. Have previously had a colonoscopy performed&#xD;
&#xD;
          3. At least 18 years of age&#xD;
&#xD;
          4. Subjects must be scheduled for a morning colonoscopy (prior to 12:00PM)&#xD;
&#xD;
          5. If female, and of child-bearing potential, is using an acceptable form of birth&#xD;
             control.&#xD;
&#xD;
          6. Negative urine pregnancy test at screening, if applicable&#xD;
&#xD;
          7. In the Investigator's judgment, subject is mentally competent to provide informed&#xD;
             consent to participate in the study&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal&#xD;
             obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.&#xD;
&#xD;
          2. Subjects who had previous significant gastrointestinal surgeries.&#xD;
&#xD;
          3. Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with&#xD;
             clinically significant electrolyte abnormalities based on Visit 1 laboratory results.&#xD;
&#xD;
          4. Subjects with a prior history of renal, liver or cardiac insufficiency&#xD;
&#xD;
          5. Subjects with impaired consciousness that predisposes them to pulmonary aspiration.&#xD;
&#xD;
          6. Subjects undergoing colonoscopy for foreign body removal and/or decompression.&#xD;
&#xD;
          7. Subjects who are pregnant or lactating, or intending to become pregnant during the&#xD;
             study.&#xD;
&#xD;
          8. Subjects of childbearing potential who refuse a pregnancy test.&#xD;
&#xD;
          9. Subjects allergic to any preparation components.&#xD;
&#xD;
         10. 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;
         11. 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>N/A</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 1</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <disposition_first_submitted>September 26, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>September 26, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">September 28, 2018</disposition_first_posted>
  <last_update_submitted>September 26, 2018</last_update_submitted>
  <last_update_submitted_qc>September 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2018</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, but a results disposition has been submitted           -->
</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/NCT03023085
org study id: BLI4700-201
nct id: NCT03023085
lead sponsor: 
has dmc: No
The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel
      preparation prior to colonoscopy in adult patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: % of subjects with successful bowel preparation
time frame: Day of colonoscopy
description: % of subjects with successful bowel preparation rated by blinded colonoscopist on a 4 point scale (1=poor to 4 = excellent)
measure: Frequency of adverse events
time frame: 7 days
arm group label: BLI4700
arm group type: Experimental
description: BLI4700 Bowel Preparation
intervention type: Drug
intervention name: BLI4700
description: BLI4700 bowel preparation
arm group label: BLI4700
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John McGowan, MPH
role: Study Director
affiliation: Braintree Laboratories, Inc.
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No