Efficacy, Safety and Tolerability of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy
Completed · Phase 2
Conditions studied: Colonoscopy
In brief
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 facts
- Study ID
- NCT02189850
- Run by
- Braintree Laboratories
- People needed
- 29
- Starts
- 2014-06-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2021-03-15
Who can join
Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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.
Where it is running
- Arkansas Children's Hospital Research Institute — Little Rock, Arkansas, United States
- Children's Center for Digestive Health Care — Atlanta, Georgia, United States
- Delta Research Partners — Bastrop, Louisiana, United States
- Gastrointestinal Associates — Jackson, Mississippi, United States
- University of Buffalo Pediatric Associates — Buffalo, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.