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

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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.


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.
We found this trial at
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Buffalo, NY
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Atlanta, GA
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Bastrop, Louisiana 71220
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Jackson, Mississippi 39202
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Jackson, MS
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Little Rock, AR
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