Colon Cleansing with Prepopik Before Colonoscopy – Phases I & II

Study Comparing the Safety and Efficacy of Prepopik versus Polyethylene Glycol Preparation in Children

Protocol Description

The purpose of this multicenter study is to compare pediatric patient experiences with Prepopik® versus polyethylene glycol (PEG) for overall colon cleansing in preparation for colonoscopy. Prepopik, which has been approved for use in adults and is being investigated for use with pediatric patients, may be easier for patients because it requires a lower consumption of prep solution than the current standard of care.

Study Level: Phase I & II

Eligibility Criteria

Subject to certain exclusion criteria, boys and girls aged 9 to 16 years, who are being scheduled to undergo elective colonoscopy, are eligible.
Boys: 9 to 16 years old
Girls: 9 to 16 years old


After an initial screening visit that will include a physical examination, blood and urine sampling, participants will be randomly assigned to take either PEG or a prescribed dosage of Prepopik in preparation for their colonoscopies. Participants involved in the pharmacokinetic testing portion of the study, which requires extra blood draws, will be required to spend the night before colonoscopy in Children’s Hospital of Pittsburgh of UPMC.
Visits: 5, including colonoscopy and telephone follow-up
Duration: Approximately 1 month

Status: Open for Enrollment

Source(s) of Support

Ferring International Center U.S., Inc.

Primary Investigator

Dale King, MD

Contact Information

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