Bowel Preparation with BLI800 Before Colonoscopy – Phase III

Study of Bowel Cleansing Preparation BLI800 in Pediatric Patients Undergoing Colonoscopy

Protocol Description

The purpose of this study is to compare the effectiveness and side effects, if any, of BLI800 against NuLYTELY®, a bowel preparation that is approved for pediatric use prior to colonoscopy. BLI800 is already approved by the FDA for adult use, and this study is determining appropriate dosing for adolescents. BLI800 may be easier for patients because it requires less prep solution than the current standard of care.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, boys and girls aged 12 to 16 years, who are being scheduled to undergo a colonoscopy, are eligible.
Boys and Girls: 12 to 16 years

Requirements

Prior to colonoscopy, participants will be assigned to take either BLI800 or NuLYTELY for their bowel preparation. For those participants taking the study drug, BLI800 will be provided for consumption the evening before the scheduled colonoscopy at either the full adult dose (6 ounces) or ¾ the adult dose (4.5 ounces). On the morning of the colonoscopy, a second dose of the study medication may be required at least 3 hours before the procedure. Following colonoscopy, participants will return twice, and possibly a third time, for visits that will include a physical examination, blood and urine sample collection.
Visits: Up to 5
Duration: Up to 32 days

Status: Open to Enrollment

Source(s) of Support

Braintree Laboratories

Primary Investigator

Dale King, MD

Contact Information

For more information about the study or enrollment, please contact:
Kathleen Calabro RN, BSN
412-692-6092