• Overview
  • Eligibility
  • More info
  • Locations

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
    All
    Accepts Healthy Volunteers
    No
    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
      recruiting
      Anaheim, California, United States
    Status:
    recruiting
    Type:
    Interventional
    Phase:
    Ⅰ, Ⅱ
    Start:
    31 July, 2016
    Updated:
    12 January, 2017
    Participants:
    80
    Apply
    A girl giving information about available additional trials.

    FindMeCure helps you find, understand and join clinical trials from all over the world.

    There are more clinical trials for your condition!