Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy (PICCOLO)

Ferring

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Bowel Preparation

Treatments: Drug: MIRALAX; Drug: CLENPIQ

Study type: Interventional

Funder types: Industry

Identifiers

NCT04113382

000359

Details and patient eligibility

About

Bowel preparation for pediatric colonoscopy.

Enrollment: 30 estimated patients

Sex: All

Ages: 2 to 8 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 4 patient groups

Participants aged 2 to <4 years: CLENPIQ

Experimental group

Description:

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.

Treatment:

Drug: CLENPIQ

Participants aged 2 to <4 years: MIRALAX

Active Comparator group

Description:

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.

Treatment:

Drug: MIRALAX

Participants aged 4 to <9 years: CLENPIQ

Experimental group

Description:

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.

Treatment:

Drug: CLENPIQ

Participants aged 4 to <9 years: MIRALAX

Active Comparator group

Description:

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.

Treatment:

Drug: MIRALAX