Efficacy, Safety and Tolerability of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy
Status: | Completed |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 12 - 17 |
Updated: | 7/20/2016 |
Start Date: | June 2014 |
The purpose o this study is to evaluate the safety, tolerance and efficacy of BLI800 as a
bowel preparation prior to colonoscopy in pediatric patients.
bowel preparation prior to colonoscopy in pediatric patients.
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.
Exclusion Criteria:
- 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.
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