Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-23

Study Completion Date

2026-03-31

Brief Summary

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Bowel preparation for pediatric colonoscopy.

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Detailed Description

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Conditions

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Bowel Preparation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Participants aged 2 to <4 years: CLENPIQ

CLENPIQ administered using "split-dose" method and consists of two separate doses: the first dose (½ bottle \[approximately 80 mL\]) one day before colonoscopy between 5:00 PM and 9:00 PM, and the second dose (½ bottle \[approximately 80 mL\]) the next day, at least 5 hours prior but no more than 9 hours prior to the colonoscopy. Following each dose, participants will consume 50 mL/kg of clear liquids, up to a limit of 1,000 mL.

Group Type EXPERIMENTAL

CLENPIQ

Intervention Type DRUG

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.

Participants aged 2 to <4 years: MIRALAX

MIRALAX 3.4 to 4.9 g/kg up to a maximum of 238 g is reconstituted with non-carbonated, clear beverage, or water and administered in increments of 4 ounce (oz) for every 30 minutes, one day before colonoscopy between 5:00 PM and 9:00 PM. Following dosing, participants will consume 50 mL/kg of clear liquids, up to a limit of 1,000 mL total weight-based maximum.

Group Type ACTIVE_COMPARATOR

MIRALAX

Intervention Type DRUG

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

Participants aged 4 to <9 years: CLENPIQ

CLENPIQ administered using "split-dose" method and consists of two separate doses: the first dose (1 bottle \[approximately 160 mL\]) one day before colonoscopy between 5:00 PM and 9:00 PM, and the second dose (½ bottle \[approximately 80 mL\]) the next day, at least 5 hours prior but no more than 9 hours prior to the colonoscopy. Following each dose, participants will consume 50 mL/kg of clear liquids, up to a limit of 1,000 mL total weight-based maximum.

Group Type EXPERIMENTAL

CLENPIQ

Intervention Type DRUG

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.

Participants aged 4 to <9 years: MIRALAX

MIRALAX 3.4 to 4.9 g/kg up to a maximum of 238 g is reconstituted with non-carbonated, clear beverage, or water and administered in increments of 8 oz for every 30 minutes one day before colonoscopy between 5:00 PM and 9:00 PM. Following dosing, participants will consume 50 mL/kg of clear liquids, up to a limit of 1,000 mL total weight-based maximum.

Group Type ACTIVE_COMPARATOR

MIRALAX

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female, aged 2 years to \<9 years being scheduled to undergo elective colonoscopy.
* Weight ≥10 kg (≥22 lbs).
* Participants must have had an average of three or more spontaneous bowel movements (SBM) per week 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.
* Clinically significant abdominal pain during the screening period.
* Severe acute inflammatory bowel disease (IBD) during the screening period.
* 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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No