Status:
COMPLETED
Efficacy, Safety and Tolerability of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy
Lead Sponsor:
Braintree Laboratories
Conditions:
Colonoscopy
Eligibility:
All Genders
12-17 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT02189850
Start Date
June 1 2014
End Date
January 1 2015
Last Update
March 15 2021
Active Locations (5)
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1
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States
2
Children's Center for Digestive Health Care
Atlanta, Georgia, United States
3
Delta Research Partners
Bastrop, Louisiana, United States
4
Gastrointestinal Associates
Jackson, Mississippi, United States