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

NCT02189850 | Completed Phase 2 Results

• 1 other identifier: BLI800-501
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 5

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

Keywords

colonoscopy; pediatric

Outcome Measures

Primary Outcomes (1)

• % 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

Study Arms (2)

BLI800 - Dose 1

EXPERIMENTAL

BLI800 oral solution

Drug: BLI800 - Dose 1

BLI800 - Dose 2

EXPERIMENTAL

BLI800 oral solution

Drug: BLI800 - Dose 2

Interventions

BLI800 - Dose 1 DRUG

BLI800 oral solution

Also known as: BLI800

BLI800 - Dose 1

BLI800 - Dose 2 DRUG

BLI800 oral solution

Also known as: BLI800

BLI800 - Dose 2

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Braintree Laboratories: lead

Study Sites (5)

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, United States

Location

Children's Center for Digestive Health Care

Atlanta, Georgia, United States

Location

Delta Research Partners

Bastrop, Louisiana, United States

Location

Gastrointestinal Associates

Jackson, Mississippi, United States

Location

University of Buffalo Pediatric Associates

Buffalo, New York, United States

Location

Results Point of Contact

• Title: Head of R&D, Gastroenterology
• Organization: Braintree Laboratories, Inc.

studydirector@sebelapharma.com

781-843-2202

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 15, 2014
• Study Start: June 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 15, 2021
• Results First Posted: March 15, 2021

Record last verified: 2021-02

Locations

US (5)