Study Assessing CLENPIQ as Bowel Preparation for Pediatri... | NCT04113382

NCT04113382

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants aged 2 to <4 years: CLENPIQ	Experimental	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.	Drug: CLENPIQ
Participants aged 2 to <4 years: MIRALAX	Active Comparator	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.	Drug: MIRALAX
Participants aged 4 to <9 years: CLENPIQ	Experimental	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.	Drug: CLENPIQ
Participants aged 4 to <9 years: MIRALAX	Active Comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CLENPIQ	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of participants classified as responders, defined by "excellent" or "good" in the Modified Aronchick scale	The efficacy of overall colon cleansing in terms of responders will be graded by a blinded endoscopist using the Modified Aronchick Scale. It is a 4-point scale that grades colon cleansing as Excellent (>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed).The participant is considered to be a responder if overall colon cleansing is "excellent" or "good" on this 4-point scale.	On the day of colonoscopy (Day 1)

Secondary Outcomes

Measure	Description	Time Frame
Percentage of participants classified as "excellent" in the Modified Aronchick scale	The efficacy of overall colon cleansing in terms of responders will be graded by a blinded endoscopist using the Modified Aronchick Scale. It is a 4-point scale that grades colon cleansing as Excellent (>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed). Percentage of participants classified as "excellent" in the Modified Aronchick scale will be reported.

Eligibility Module

Eligibility Criteria

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.

Name	Role	Phone	Extension	Email
Global Clinical Compliance	Contact	+1 833-548-1402 (US/Canada)		DK0-Disclosure@ferring.com
Global Clinical Compliance	Contact	+1 862-286-5200 (outside US)		DK0-Disclosure@ferring.com