Actively Recruiting

Phase 1
Phase 2
Age: 2Years - 8Years
All Genders
NCT04113382

Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy

Led by Ferring Pharmaceuticals · Updated on 2026-04-09

30

Participants Needed

5

Research Sites

257 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Bowel preparation for pediatric colonoscopy.

CONDITIONS

Official Title

Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy

Who Can Participate

Age: 2Years - 8Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 2 years to less than 9 years scheduled for elective colonoscopy
  • Weight of at least 10 kg (22 lbs)
  • Average of three or more spontaneous bowel movements per week for 1 month before colonoscopy
  • Written informed consent from parent(s)/caregiver(s)/guardian(s) and assent if applicable
Not Eligible

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 during screening such as obstruction or perforation
  • Clinically significant abdominal pain during screening
  • Severe acute inflammatory bowel disease during screening
  • Prior colorectal surgery except appendectomy or polyp removal
  • History of colon diseases like Hirschsprung disease, volvulus, idiopathic pseudo-obstruction, or hypomotility syndrome
  • History or ongoing intestinal ulceration, toxic megacolon, or other toxic colitis
  • History of upper gastrointestinal disorders such as active ulcers, pyloric stenosis, gastroparesis, or ileus
  • History of upper gastrointestinal surgery excluding gallbladder removal
  • Chronic or severe nausea or vomiting during screening
  • Moderate to severe dehydration during screening
  • Prior epileptic seizures or convulsions
  • Relevant neurological events during screening
  • Abnormal kidney function tests or electrolyte levels during screening
  • High magnesium levels during screening
  • Use of prohibited medications before the procedure including lithium, laxatives, drugs causing constipation, antidiarrheals, or oral iron
  • Participation in another investigational drug trial recently
  • Any abnormal medical findings that might increase risk in the opinion of investigators
  • Hypersensitivity to any trial medication ingredients
  • Inability to follow dietary restrictions or fluid requirements before and after study drug administration

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

G

Global Clinical Compliance

CONTACT

G

Global Clinical Compliance

CONTACT

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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