Study of CLENPIQ and MIRALAXSENNA for Bowel Preparation in Children Aged 12 Months to Under 9 Years Before Colonoscopy

What this Trial Is About

This trial studies bowel preparation methods for children aged 12 months to less than 9 years who are scheduled for elective colonoscopy. It compares the safety and effectiveness of CLENPIQ, a pre-mixed oral solution containing sodium picosulfate, magnesium oxide, and citric acid, to MIRALAX combined with SENNA. The trial is designed as a randomized, assessor-blind, parallel-group study conducted across multiple centers. Participants receive bowel preparation using either CLENPIQ administered in split doses or MIRALAX with SENNA. CLENPIQ doses are given one day before colonoscopy and again on the day of the procedure, with clear liquids consumed after each dose. MIRALAX is given the day before colonoscopy at specified intervals mixed with clear beverage or water, followed by clear liquids. Different dosing strategies depend on the age group, and the study includes pharmacokinetic assessments of the active ingredients. During the study, participants are monitored through assessments of bowel cleansing quality using the Modified Aronchick scale on the day of colonoscopy. Researchers also evaluate tolerability and satisfaction via questionnaires, measure systemic drug concentrations, and track safety through adverse event reporting and laboratory tests from screening through 28 days after colonoscopy. Participation involves dosing and follow-up visits around the colonoscopy procedure date.

Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy