NCT04113382

Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy

A Randomized, Assessor-Blind, Parallel-Groups, Multicenter Trial Assessing the Safety and Efficacy, Including Pharmacokinetic Assessments, of CLENPIQ in Children Aged 2 Years to Less Than 9 Years

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 2 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

Bowel preparation for pediatric colonoscopy.

Conditions

• Bowel Preparation

Interventions

Type	Name	Description
DRUG	CLENPIQ	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.
DRUG	MIRALAX	MIRALAX powder for oral solution, supplied in a 8.3 oz multi-dose bottle containing 238 g of laxative powder (polyethylene glycol \[PEG\] 3350).

Timeline

• Start date: 2022-06-23
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2019-10-02
• Last updated: 2026-04-09

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study