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New treatment option for Bowel Preparation
Official title Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy
ClinicalTrials.gov ID: NCT04113382
What this study is testing
What is CLENPIQ?
CLENPIQ is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for bowel preparation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Bowel preparation for pediatric colonoscopy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 8
You may be able to join if
- 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.
You likely can't join if
- 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).
See the full eligibility 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...
- Participation in an treatment 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Mobile, Alabama, United States
- San Diego, California, United States
- Baltimore, Maryland, United States
- The Bronx, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 8 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mobile, Alabama, United States; San Diego, California, United States; Baltimore, Maryland, United States; The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.