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

Phase 2

Completed

• Conditions: Colonoscopy
• Interventions: Drug: BLI800 - Dose 1; Drug: BLI800 - Dose 2

• Registration Number: NCT02189850
• Lead Sponsor: Braintree Laboratories

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-07-10
• Study First Submitted QC: 2014-07-14
• Study First Posted: 2014-07-15
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Disposition First Submitted: 2016-07-18
• Disposition First Submitted QC: 2016-07-18
• Disposition First Posted: 2016-07-19
• Status Verified: 2021-02
• Results First Submitted: 2021-02-02
• Results First Submitted QC: 2021-02-22
• Last Update Submitted: 2021-02-22
• Results First Posted: 2021-03-15
• Last Update Posted: 2021-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BLI800 - Dose 1	BLI800 - Dose 1	BLI800 oral solution
BLI800 - Dose 2	BLI800 - Dose 2	BLI800 oral solution

Primary Outcome Measures

Name	Time	Method
% of Subjects With Successful Preparation Rated by Colonoscopist on a 4 Point Scale (1=Poor to 4 = Excellent)	2 days	Successful Preparation, defined as a colonoscopy rated as Excellent or Good by the blinded endoscopist.; Poor: Large amounts of fecal residue, additional bowel preparation required; Fair: Enough feces even after washing and suctioning to prevent clear visualization of the entire colonic mucosa; Good: Feces and fluid requiring washing and suctioning, but still achieves clear visualization of the entire colonic mucosa; Excellent: No more than small bits of feces/fluid which can be suctioned easily; achieves clear visualization of the entire colonic mucosa

Trial Locations

Locations (5)

Gastrointestinal Associates; 🇺🇸 Jackson, Mississippi, United States

Children's Center for Digestive Health Care; 🇺🇸 Atlanta, Georgia, United States

University of Buffalo Pediatric Associates; 🇺🇸 Buffalo, New York, United States

Delta Research Partners; 🇺🇸 Bastrop, Louisiana, United States

Arkansas Children's Hospital Research Institute; 🇺🇸 Little Rock, Arkansas, United States