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

Colonoscopy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02189850
• Other study ID #: BLI800-501
• Status: Completed
• Phase: Phase 2
• Start date: June 2014
• Est. completion date: January 2015

Study information

• Verified date: February 2021
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• BLI800 - Dose 1
BLI800 oral solution
• BLI800 - Dose 2
BLI800 oral solution

Locations

Country	Name	City	State
United States	Children's Center for Digestive Health Care	Atlanta	Georgia
United States	Delta Research Partners	Bastrop	Louisiana
United States	University of Buffalo Pediatric Associates	Buffalo	New York
United States	Gastrointestinal Associates	Jackson	Mississippi
United States	Arkansas Children's Hospital Research Institute	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of Subjects With Successful Preparation Rated by Colonoscopist on a 4 Point Scale (1=Poor to 4 = Excellent)	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	2 days