NCT04113382 Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy
| NCT ID | NCT04113382 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Ferring Pharmaceuticals |
| Condition | Bowel Preparation |
| Study Type | INTERVENTIONAL |
| Enrollment | 39 participants |
| Start Date | 2022-06-23 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 39 participants in total. It began in 2022-06-23 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Bowel preparation for pediatric colonoscopy.
Eligibility Criteria
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.
Contact & Investigator
Ferring Pharmaceuticals A/S
STUDY DIRECTOR
Ferring Pharmaceuticals
Frequently Asked Questions
Who can join the NCT04113382 clinical trial?
This trial is open to participants of all sexes, aged 12 Months or older, up to 8 Years, studying Bowel Preparation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04113382 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04113382 currently recruiting?
Yes, NCT04113382 is actively recruiting participants. Contact the research team at Disclosure@ferring.com for enrollment information.
Where is the NCT04113382 trial being conducted?
This trial is being conducted at Mobile, United States, San Diego, United States, Baltimore, United States, Baltimore, United States.
Who is sponsoring the NCT04113382 clinical trial?
NCT04113382 is sponsored by Ferring Pharmaceuticals. The principal investigator is Ferring Pharmaceuticals A/S at Ferring Pharmaceuticals. The trial plans to enroll 39 participants.