A Randomized, Assessor-Blind, Parallel-Groups, Multicenter Trial Assessing the Safety and Efficacy, Including Pharmacokinetic Assessments, of CLENPIQ in Children Aged 12 Months to Less Than 9 Years
Ferring Pharmaceuticals
Summary
Bowel preparation for pediatric colonoscopy.
Eligibility
- Age range
- 1–8 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female, aged 12 months to \<9 years being scheduled to undergo elective colonoscopy. * Weight ≥10 kg (≥22 lbs). * Participants must have had regular spontaneous bowel movements (SBM) weekly for 1 month prior to the colonoscopy. * Written informed consent (by parent(s)/ caregiver(s)/ guardian(s)) and assent (if applicable) obtained at screening. Exclusion Criteria: * History of significant liver, cardiovascular, or renal disease (including recent or ongoing oliguria). * Acute surgical abdominal conditions (e.g., acute obstruction or perforation) during the scree…
Interventions
- DrugCLENPIQ
CLENPIQ consists of sodium picosulfate 10.0 mg + magnesium oxide 3.5 g + citric acid, anhydrous 12.0 g. Supplied as a pre-mixed, ready-to-drink oral solution in two bottles, each containing 160 mL.
- DrugMIRALAX
MIRALAX powder for oral solution, supplied in a 8.3 oz multi-dose bottle containing 238 g of laxative powder (polyethylene glycol \[PEG\] 3350). MIRALAX is mixed with non-carbonated, clear beverage, or water and consumed at specified intervals until the total required dose.
- DrugSENNA
SENNA Liquid (chocolate flavor) is an oral solution to be taken according to body weight (8.8 mg for 10-22 kg, 17.6 mg for 22-34 kg and 26.4 mg for \>34 kg) prior to MIRALAX.
Locations (5)
- Ferring Investigational SiteMobile, Alabama
- Ferring Investigational SiteSan Diego, California
- Ferring Investigational SiteBaltimore, Maryland
- Ferring Investigational SiteBaltimore, Maryland
- Ferring Investigational SiteThe Bronx, New York