Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy
Purpose
Bowel preparation for pediatric colonoscopy.
Condition
- Bowel Preparation
Eligibility
- Eligible Ages
- Between 12 Months and 8 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Screening
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Participants aged 2 to <4 years: CLENPIQ |
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. |
|
|
Active Comparator Participants aged 2 to <4 years: MIRALAX+SENNA |
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. |
|
|
Experimental Participants aged 4 to <9 years: CLENPIQ |
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. |
|
|
Active Comparator Participants aged 4 to <9 years: MIRALAX+SENNA |
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. |
|
|
Experimental Participants aged 12 months to <2 years: CLENPIQ |
CLENPIQ administered using "split-dose" method and consists of two separate doses: the first dose (1/4 bottle [approximately 40 mL]) one day before colonoscopy between 5:00 PM and 9:00 PM, and the second dose (1/4 bottle [approximately 40 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. |
|
|
Active Comparator Participants aged 12 months to <2 years: MIRALAX+SENNA |
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. |
|
Recruiting Locations
University of Maryland, Baltimore
Baltimore, Maryland 21201
Baltimore, Maryland 21201
More Details
- Status
- Recruiting
- Sponsor
- Ferring Pharmaceuticals