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

NCT ID: NCT02189850

Last Updated: 2021-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-01-31

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.

Conditions

Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BLI800 - Dose 1

BLI800 oral solution

Group Type: EXPERIMENTAL

BLI800 - Dose 1

Intervention Type: DRUG

BLI800 oral solution

BLI800 - Dose 2

BLI800 oral solution

Group Type: EXPERIMENTAL

BLI800 - Dose 2

Intervention Type: DRUG

BLI800 oral solution

Interventions

BLI800 - Dose 1

BLI800 oral solution

Intervention Type: DRUG

BLI800 - Dose 2

BLI800 oral solution

Intervention Type: DRUG

Other Intervention Names

BLI800; BLI800

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Braintree Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Other Identifiers

BLI800-501

Identifier Type: -

Identifier Source: org_study_id