Efficacy, Safety and Tolerability of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy

Braintree Laboratories

Status and phase

Completed

Phase 2

Conditions

Colonoscopy

Treatments

Drug: BLI800 - Dose 1

Drug: BLI800 - Dose 2

Study type

Interventional

Funder types

Industry

Identifiers

NCT02189850

BLI800-501

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

All

Ages

12 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.