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A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects (NCT03023085)

The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel preparation prior to colonoscopy in adult patients.
  • Drug: BLI4700
    BLI4700 bowel preparation
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    Accepts Healthy Volunteers
    Inclusion Criteria:
    • Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
    • Have previously had a colonoscopy performed
    • At least 18 years of age
    • Subjects must be scheduled for a morning colonoscopy (prior to 12:00PM)
    • If female, and of child-bearing potential, is using an acceptable form of birth control.
    • Negative urine pregnancy test at screening, if applicable
    • In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study Key
    Exclusion Criteria:
    • Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
    • Subjects who had previous significant gastrointestinal surgeries.
    • Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
    • Subjects with a prior history of renal, liver or cardiac insufficiency
    • Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
    • Subjects undergoing colonoscopy for foreign body removal and/or decompression.
    • Subjects who are pregnant or lactating, or intending to become pregnant during the study.
    • Subjects of childbearing potential who refuse a pregnancy test.
    • Subjects allergic to any preparation components.
    • Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
    • Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.

    1 locations

    United States (1)
    • Braintree Research Site 1
      Anaheim, California, United States
    Ⅰ, Ⅱ
    31 July, 2016
    12 January, 2017
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