Study Assessing CLENPIQ as 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 12 Months to Less Than 9 Years

Overview

Bowel preparation for pediatric colonoscopy.

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). MIRALAX is mixed with non-carbonated, clear beverage, or water and consumed at specified intervals until the total required dose.
• Drug SENNA
  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.

Primary outcome measures

• Percentage of participants classified as responders, defined by "excellent" or "good" in the Modified Aronchick scale [Time frame: On the day of colonoscopy (Day 1)]

Secondary outcome measures (12)

• Percentage of participants classified as "excellent" in the Modified Aronchick scale [Time frame: On the day of colonoscopy (Day 1)]
• Percentage of participants who completed the assigned dose of CLENPIQ among participants in whom nasogastric tube was not utilized to assist with CLENPIQ dosing [Time frame: From randomization (Day -1) up to second dose of CLENPIQ (Day 1)]
• Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How easy was it for you/the child to drink the bowel cleanout medicine? [Time frame: On the day of colonoscopy (Day 1)]
• Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How did the bowel cleanout medicine taste? [Time frame: On the day of colonoscopy (Day 1)]
• Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How often did your/the child's tummy hurt since you/the child started the cleanout? [Time frame: On the day of colonoscopy (Day 1)]
• Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How often did you/the child feel fullness in your/the child's tummy since you/the child started the cleanout? [Time frame: On the day of colonoscopy (Day 1)]
• Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How often did you/the child wake up last night? [Time frame: On the day of colonoscopy (Day 1)]
• Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How often did you/the child feel sick to your/the child's stomach (nausea) since you/the child started the cleanout? [Time frame: On the day of colonoscopy (Day 1)]
• Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How much were you/the child bothered by going to the bathroom since you/the child started the cleanout? [Time frame: On the day of colonoscopy (Day 1)]
• Systemic concentrations of picosulfate and bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM, active metabolite of picosulfate) [Time frame: 3 to 6 hours after the second dose of CLENPIQ prior to colonoscopy (Day 1).]
• Systemic concentrations of magnesium at screening [Time frame: Screening (≤21 days before scheduled colonoscopy)]
• Systemic concentrations of magnesium after randomization [Time frame: 3 to 6 hours after second dose of CLENPIQ prior to colonoscopy (Day 1); 1 or 2 days after the colonoscopy (Day 2 or 3)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Screening

Study locations

United States · 5 centers

• Ferring Investigational Site — Mobile
• Ferring Investigational Site — San Diego
• Ferring Investigational Site — Baltimore
• Ferring Investigational Site — Baltimore
• Ferring Investigational Site — The Bronx

Identifiers

NCT: NCT04113382 · 000359

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗