Efficacy, Safety and Tolerability of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy
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Layout table for eligibility information
Ages Eligible for Study:
12 Years to 17 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Key Inclusion Criteria:
Male or female between the ages of 12 to 17
Weight more than 40kg
Undergoing colonoscopy for routinely accepted indications
If female, and of child-bearing potential, subject must use an acceptable form of birth control or remain abstinent for the duration of the study.
Negative pregnancy test at screening, if applicable
In the Investigator's judgment, caregiver is mentally competent to provide informed consent for their child to participate in the study.
Subjects with known or suspected ileus, impaction, severe ulcerative colitis, acute peritonitis, gastrointestinal obstruction, gastric retention (gastroparesis), bowel perforation, toxic colitis or megacolon.
Subjects who had previous significant gastrointestinal surgeries.
Subjects with increased risk of bowel perforation, including connective tissue disorders, toxic dilation of the bowel or recent bowel surgery.
Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results
Subjects with bleeding disorders and/or impaired platelet function, or neutropenia.
Subjects with a prior history of renal, liver or cardiac insufficiency
Subjects required to take any other oral medication within 3 hours of dosing until completion of both doses.
Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
Subjects with tendency for nausea and/or vomiting, or that have known swallowing disorders.
Subjects for whom intake of substances is likely to affect gastrointestinal motility or urinary flow rate.
Subjects undergoing colonoscopy for foreign body removal and/or decompression.