Assessing CLENPIQ for bowel preparation in children undergoing colonoscopy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of CLENPIQ as a bowel preparation method for pediatric patients scheduled for elective colonoscopy. It involves children aged 2 to less than 9 years who meet specific criteria regarding bowel movement frequency and weight. Participants will receive either CLENPIQ or MIRALAX to determine the best approach for ensuring adequate bowel cleansing prior to the procedure.

Why it matters

Who can join: the full rules

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 screening period.
* Concern for obstipation or fecal impaction.
* Severe acute inflammatory bowel disease (IBD) defined as subjects with a Pediatric Ulcerative Colitis Activity Index (PUCAI) score \>65 or a Short Pediatric Crohn's Disease Activity Index (short PCDAI) score \>40, at the time of screening, or development of severe IBD between (Visit 1) and investigational medicinal product (IMP) dispensation (Visit 2).
* Any prior colorectal surgery, excluding appendectomy and polyp removal.
* History of colon disease (e.g., Hirschsprung disease, volvulus, idiopathic pseudo-obstruction, or hypomotility syndrome).
* History of or ongoing intestinal ulceration, toxic megacolon or other toxic colitis.
* History of upper gastrointestinal disorder (e.g., active ulcer, pyloric stenosis or other cause of gastric retention, gastroparesis, or ileus).
* History of upper gastrointestinal surgery (e.g., gastric resection or gastric bypass), excluding cholecystectomy.
* Chronic or persistent, severe nausea or vomiting during the screening period.
* Moderate to severe dehydration during the screening period.
* Prior history of epileptic reaction, convulsions, or seizures.
* Any clinically relevant neurological events with or without association with hyponatremia during the screening period.
* Serum creatinine, estimated glomerular filtration rate (eGFR), potassium, or sodium outside normal limits during the screening period.
* Hypermagnesemia during the screening period.
* Use of the following prohibited medication: lithium (within 48 hours prior to procedure), laxatives (within 24 hours prior to procedure), drugs that in the opinion of the investigator are causing constipation in the participant (within 48 hours prior to procedure), antidiarrheal drugs (within 72 hours prior to procedure), or oral iron preparations (within 1 week prior to procedure).
* Participation in an interventional investigational trial requiring administration of an investigational drug within 30 days prior to receiving trial medication (or within 60 days for investigational drugs with an elimination half-life \>15 days).
* Any clinically relevant abnormal findings in medical history, physical examination, vital signs, electrocardiogram (ECG), clinical chemistry, hematology, coagulation, or urinalysis at screening which in the opinion of the investigator(s), might put the participant at risk because of his/her participation in the trial.
* Hypersensitivity to any of the ingredients of the trial medications.
* Inability to comply with the dietary restrictions in the trial or the fluid requirements before and after investigational medicinal product (IMP) administration.

Where it's running

• South Alabama Medical Science Foundation
  Mobile, Alabama, United States Recruiting
• Rady Children's Hospital (San Diego)
  San Diego, California, United States Recruiting
• University of Maryland, Baltimore
  Baltimore, Maryland, United States Recruiting
• Johns Hopkins Children's Medical Center
  Baltimore, Maryland, United States Recruiting

Study contacts

• Study coordinator: Ferring Pharmaceuticals
• Email: Disclosure@ferring.com
• Phone: +1 833-548-1402 (US/Canada)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.