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RECRUITING
NCT04113382
PHASE1/PHASE2

Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy

Sponsor: Ferring Pharmaceuticals

View on ClinicalTrials.gov

Summary

Bowel preparation for pediatric colonoscopy.

Official title: 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

Key Details

Gender

All

Age Range

2 Years - 8 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2022-06-23

Completion Date

2027-06

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

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).

Locations (5)

Ferring Investigational Site

Mobile, Alabama, United States

Ferring Investigational Site

San Diego, California, United States

Ferring Investigational Site

Baltimore, Maryland, United States

Ferring Investigational Site

Baltimore, Maryland, United States

Ferring Investigational Site

The Bronx, New York, United States