RECRUITING

Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy

Conditions

Bowel Preparation Colon Cleansing Preparation for Colonoscopy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2022-06-23

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04113382

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 8 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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.	* 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

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Global Clinical Compliance

CONTACT

+1 833-548-1402 (US/Canada)

DK0-Disclosure@ferring.com

Global Clinical Compliance

CONTACT

+1 862-286-5200 (outside US)

DK0-Disclosure@ferring.com

Principal Investigator

Global Clinical Compliance

STUDY_DIRECTOR

Ferring Pharmaceuticals

Study Locations (Sites)

Ferring Investigational Site

Mobile, Alabama, 36604

United States

Rady Children's Hospital

San Diego, California, 92123

United States

Ferring Investigational Site

Baltimore, Maryland, 21287

United States

The Children's Hospital at Montefiore

Bronx, New York, 10467

United States

Collaborators and Investigators

Sponsor: Ferring Pharmaceuticals

Global Clinical Compliance, STUDY_DIRECTOR, Ferring Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-23

Study Completion Date2026-03

Study Record Updates

Study Start Date2022-06-23

Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

Colon Cleansing
Preparation for Colonoscopy

Additional Relevant MeSH Terms

Bowel Preparation