Actively Recruiting
A Randomized, Assessor-Blind, Multicenter Trial Assessing the Safety and Efficacy of CLENPIQ Compared to MIRALAX for Bowel Preparation in Children Aged 2 to Less Than 9 Years
Led by Ferring Pharmaceuticals · Updated on 2026-04-09
30
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial studies bowel preparation methods for children aged 2 to less than 9 years who are scheduled for an elective colonoscopy. It aims to compare the safety and effectiveness of CLENPIQ, a pre-mixed oral solution, to MIRALAX, a laxative powder, in preparing the bowel before the procedure. The study also includes pharmacokinetic assessments to understand how CLENPIQ is processed in the body. Participants receive one of four treatments based on age and bowel preparation type. CLENPIQ is given in two doses: a half or full bottle the evening before colonoscopy and a half bottle the next day several hours before the procedure, each followed by clear liquid intake. MIRALAX dosing is weight-based and administered the evening before colonoscopy in increments every 30 minutes, also followed by clear liquids. The study is randomized and assessor-blind with parallel groups. During the study, participants will be evaluated for bowel cleanliness using the Modified Aronchick scale on the day of colonoscopy. Researchers will monitor tolerability, satisfaction, and systemic drug levels, as well as safety through vital signs, lab tests, and adverse event tracking for up to 28 days post-colonoscopy. Participation involves dosing the study treatment, attending the colonoscopy, and undergoing monitoring visits over about one month.
CONDITIONS
Brief Title
Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female children aged 2 to less than 9 years scheduled for elective colonoscopy
- Weight of at least 10 kilograms (22 pounds)
- Average of three or more spontaneous bowel movements per week for one month prior to colonoscopy
- Written informed consent from parent(s), caregiver(s), or guardian(s) and assent if applicable
You will not qualify if you...
- History of significant liver, cardiovascular, or kidney disease including recent or ongoing low urine output
- Acute surgical abdominal conditions such as obstruction or perforation during screening
- Clinically significant abdominal pain during screening
- Severe acute inflammatory bowel disease during screening
- Prior colorectal surgery except appendix removal and polyp removal
- History of colon diseases like Hirschsprung disease, volvulus, pseudo-obstruction, or hypomotility syndrome
- History or ongoing intestinal ulceration, toxic megacolon, or toxic colitis
- History of upper gastrointestinal disorders or surgeries excluding cholecystectomy
- Chronic or severe nausea or vomiting during screening
- Moderate to severe dehydration during screening
- Prior epileptic reactions, convulsions, or seizures
- Relevant neurological events during screening
- Abnormal kidney function or electrolyte levels during screening
- Use of prohibited medications like lithium, laxatives, antidiarrheal drugs, or oral iron preparations within specified timeframes before procedure
- Participation in another investigational drug trial within specified timeframes
- Any medical findings that increase risk as judged by investigators
- Hypersensitivity to trial medication ingredients
- Inability to follow dietary or fluid restrictions before and after study medication administration
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - Up to 3 weeks before colonoscopy
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - The day before and the day of colonoscopy
Participants receive bowel preparation medication (either CLENPIQ or MIRALAX) prior to their colonoscopy.
2 dosing times: one dose the evening before colonoscopy and one dose the morning of colonoscopy
Duration - 1 day
Participants undergo colonoscopy following bowel preparation.
1 visit (in-person)
Duration - Up to 28 days after colonoscopy
Participants are monitored for safety and any adverse events after colonoscopy.
Follow-up visits or contacts as needed up to 28 days
Trial Site Locations
Total: 5 locations
1
Ferring Investigational Site
Mobile, Alabama, United States, 36604
Actively Recruiting
2
Ferring Investigational Site
San Diego, California, United States, 92123
Actively Recruiting
3
Ferring Investigational Site
Baltimore, Maryland, United States, 21201
Actively Recruiting
4
Ferring Investigational Site
Baltimore, Maryland, United States, 21287
Actively Recruiting
5
Ferring Investigational Site
The Bronx, New York, United States, 10467
Actively Recruiting
Research Team
G
Global Clinical Compliance
G
Global Clinical Compliance
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
4
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