Clinical trial NCT04113382: 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 2 Years to Less Than 9 Years
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Bowel Preparation
Keywords: Colon Cleansing
Preparation for Colonoscopy
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-10-02
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Bowel preparation for pediatric colonoscopy.


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.

Primary outcomes:
measure: Percentage of participants classified as responders, defined by "excellent" or "good" in the Modified Aronchick scale
timeFrame: On the day of colonoscopy (Day 1)
Secondary outcomes:
measure: Percentage of participants classified as "excellent" in the Modified Aronchick scale
timeFrame: On the day of colonoscopy (Day 1)
measure: Percentage of participants who completed the assigned dose of CLENPIQ among participants in whom nasogastric tube was not utilized to assist with CLENPIQ dosing
timeFrame: From randomization (Day -1) up to second dose of CLENPIQ (Day 1)
measure: 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?
timeFrame: On the day of colonoscopy (Day 1)
measure: Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How did the bowel cleanout medicine taste?
timeFrame: On the day of colonoscopy (Day 1)
measure: 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?
timeFrame: On the day of colonoscopy (Day 1)
measure: 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?
timeFrame: On the day of colonoscopy (Day 1)
measure: Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How often did you/the child wake up last night?
timeFrame: On the day of colonoscopy (Day 1)
measure: 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?
timeFrame: On the day of colonoscopy (Day 1)
measure: 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?
timeFrame: On the day of colonoscopy (Day 1)
measure: Systemic concentrations of picosulfate and bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM, active metabolite of picosulfate) after randomization
timeFrame: For PK1 subset: 3 to 6 hours after the second dose of CLENPIQ prior to colonoscopy (Day 1); For PK3 subset: 15 minutes before, 1 to 2 hours, and 3 to 6 hours after second dose of CLENPIQ prior to colonoscopy (Day 1)
measure: Systemic concentrations of magnesium at screening
timeFrame: Screening (≤21 days before scheduled colonoscopy)
measure: Systemic concentrations of magnesium after randomization
timeFrame: 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)
measure: Percentage of participants with adverse events (AEs)
timeFrame: From screening (≤21 days before scheduled colonoscopy) up to Day 28±7 after colonoscopy
measure: Percentage of participants with abnormal findings in vital signs
timeFrame: From screening (≤21 days before scheduled colonoscopy) up to Day 28±7 after colonoscopy
measure: Percentage of participants with abnormal findings in clinical laboratory tests
timeFrame: From screening (≤21 days before scheduled colonoscopy) up to Day 28±7 after colonoscopy
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Ferring Investigational Site
state: Alabama
city: San Diego
country: United States
facility: Ferring Investigational Site
state: California
city: Baltimore
country: United States
facility: Ferring Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Ferring Investigational Site
state: Maryland
city: Bronx
country: United States
facility: Ferring Investigational Site
state: New York
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References: