RecruitingPhase 1Phase 2NCT04113382

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 12 Months to Less Than 9 Years


Sponsor

Ferring Pharmaceuticals

Enrollment

39 participants

Start Date

Jun 23, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Bowel preparation for pediatric colonoscopy.


Eligibility

Min Age: 12 MonthsMax Age: 8 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called CLENPIQ, a drug called MIRALAX, and others for people with bowel preparation. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 12 Months to 8 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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(4)

South Alabama Medical Science Foundation

Mobile, Alabama, United States

Rady Children's Hospital (San Diego)

San Diego, California, United States

University of Maryland, Baltimore

Baltimore, Maryland, United States

Johns Hopkins Children's Medical Center

Baltimore, Maryland, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04113382


Related Trials