Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy

Brief Summary
Bowel preparation for pediatric colonoscopy.
Brief Title
Study Assessing CLENPIQ As Bowel Preparation for Pediatric Colonoscopy
Central Contacts
Central Contact Role
Contact
Central Contact Phone
+1 833-548-1402 (US/Canada)
Central Contact Email
DK0-Disclosure@ferring.com
Central Contact Role
Contact
Central Contact Phone
+1 862-286-5200 (outside US)
Central Contact Email
DK0-Disclosure@ferring.com
Completion Date
Completion Date Type
Estimated
Conditions
Bowel Preparation
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.
Inclusion 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.

Gender
All
Gender Based
false
Keywords
Colon Cleansing
Preparation for Colonoscopy
Healthy Volunteers
No
Last Update Submit Date
Maximum Age
8 Years
Minimum Age
2 Years
NCT Id
NCT04113382
Org Class
Industry
Org Full Name
Ferring Pharmaceuticals
Org Study Id
000359
Overall Status
Recruiting
Phases
Phase 1
Phase 2
Primary Completion Date
Primary Completion Date Type
Estimated
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
Primary Outcomes
Outcome Description
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.
Outcome Measure
Percentage of participants classified as responders, defined by "excellent" or "good" in the Modified Aronchick scale
Outcome Time Frame
On the day of colonoscopy (Day 1)
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
On the day of colonoscopy (Day 1)
Outcome Measure
Percentage of participants classified as "excellent" in the Modified Aronchick scale
Outcome Description
A nasogastric tube may be inserted if the participant is likely to fail to drink the prescribed amount of cleanout preparation within the required time. Percentage of participants who completed the assigned dose of CLENPIQ without utilizing nasogastric tube will be reported.
Outcome Time Frame
From randomization (Day -1) up to second dose of CLENPIQ (Day 1)
Outcome 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
Outcome Description
The tolerability and satisfaction of colon cleansing preparation for colonoscopy will be assessed by the child/ parent(s)/caregiver(s)/guardian(s) using modified tolerability and satisfaction questionnaire. The above question will be answered on a 6-point scale: (1=very easy, 2=easy, 3=okay, 4=difficult, 5=very difficult, 6=do not know).
Outcome Time Frame
On the day of colonoscopy (Day 1)
Outcome 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?
Outcome Description
The tolerability and satisfaction of colon cleansing preparation for colonoscopy will be assessed by the child/ parent(s)/caregiver(s)/guardian(s) using modified tolerability and satisfaction questionnaire. The above question will be answered on a 6-point scale: (1=very well, 2=well, 3=okay, 4=bad, 5=very bad, 6=do not know).
Outcome Time Frame
On the day of colonoscopy (Day 1)
Outcome Measure
Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How did the bowel cleanout medicine taste?
Outcome Description
The tolerability and satisfaction of colon cleansing preparation for colonoscopy will be assessed by the child/parent(s)/caregiver(s)/guardian(s) using modified tolerability and satisfaction questionnaire. The above question will be answered on a 6-point scale: (1=never, 2=rarely, 3=sometimes, 4=often, 5=very often, 6=do not know).
Outcome Time Frame
On the day of colonoscopy (Day 1)
Outcome 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?
Outcome Description
The tolerability and satisfaction of colon cleansing preparation for colonoscopy will be assessed by the child/ parent(s)/caregiver(s)/guardian(s) using modified tolerability and satisfaction questionnaire. The above question will be answered on a 6-point scale: (1=never, 2=rarely, 3=sometimes, 4=often, 5=very often, 6=do not know).
Outcome Time Frame
On the day of colonoscopy (Day 1)
Outcome 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?
Outcome Description
The tolerability and satisfaction of colon cleansing preparation for colonoscopy will be assessed by the child/ parent(s)/caregiver(s)/guardian(s) using modified tolerability and satisfaction questionnaire. The above question will be answered on a 6-point scale: (1=never, 2=rarely, 3=sometimes, 4=often, 5=very often, 6=do not know).
Outcome Time Frame
On the day of colonoscopy (Day 1)
Outcome Measure
Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How often did you/the child wake up last night?
Outcome Description
The tolerability and satisfaction of colon cleansing preparation for colonoscopy will be assessed by the child/ parent(s)/caregiver(s)/guardian(s) using modified tolerability and satisfaction questionnaire. The above question will be answered on a 6-point scale: (1=never, 2=rarely, 3=sometimes, 4=often, 5=very often, 6=do not know).
Outcome Time Frame
On the day of colonoscopy (Day 1)
Outcome 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?
Outcome Description
The tolerability and satisfaction of colon cleansing preparation for colonoscopy will be assessed by the child/parent(s)/caregiver(s)/guardian(s) using modified tolerability and satisfaction questionnaire. The above question will be answered on a 6-point scale: (1=never, 2=rarely, 3=sometimes, 4=often, 5=very often, 6=do not know).
Outcome Time Frame
On the day of colonoscopy (Day 1)
Outcome 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?
Outcome Description
For the assessment of picosulfate and BHPM concentrations, participants randomized to CLENPIQ will be further randomized (1:1 ratio) for collection of either 1 pharmacokinetic (PK) sample (PK1 subset) or 3 PK samples (PK3 subset).
Outcome Time Frame
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)
Outcome Measure
Systemic concentrations of picosulfate and bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM, active metabolite of picosulfate) after randomization
Outcome Description
At screening, PK assessments of magnesium concentrations will be performed for all participants.
Outcome Time Frame
Screening (≤21 days before scheduled colonoscopy)
Outcome Measure
Systemic concentrations of magnesium at screening
Outcome Description
After randomisation, PK assessments of magnesium concentrations will be performed only for the participants randomized to CLENPIQ.
Outcome 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)
Outcome Measure
Systemic concentrations of magnesium after randomization
Outcome Description
An AE is defined as any untoward medical occurrence in a participant participating in a clinical study.

Percentage of participants with any AE (serious or non-serious) will be presented.
Outcome Time Frame
From screening (≤21 days before scheduled colonoscopy) up to Day 28±7 after colonoscopy
Outcome Measure
Percentage of participants with adverse events (AEs)
Outcome Description
Percentage of participants with abnormal findings (clinically significant) in vital signs will be reported.
Outcome Time Frame
From screening (≤21 days before scheduled colonoscopy) up to Day 28±7 after colonoscopy
Outcome Measure
Percentage of participants with abnormal findings in vital signs
Outcome Description
Percentage of participants with abnormal findings (clinically significant) in clinical laboratory tests will be reported.
Outcome Time Frame
From screening (≤21 days before scheduled colonoscopy) up to Day 28±7 after colonoscopy
Outcome Measure
Percentage of participants with abnormal findings in clinical laboratory tests
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
8
Minimum Age Number (converted to Years and rounded down)
2
Investigators
Investigator Type
Principal Investigator
Investigator Name
Inna Novak
Investigator Email
inovak@montefiore.org
Investigator Phone
718-741-2332