Study Details
Functional Constipation Study - Clinical Trial using Prucalopride compared to placebo
(IRB#: IRB_00141463)
We are asking you to allow your child to take part in a research study for prucalopride (called the study drug) because they have been diagnosed with functional constipation. Constipation happens when your child has fewer than 3 bowel movements a week. Functional constipation is a condition in which your child withholds stool, usually because they are afraid of the pain associated with passing of hard stools or due to social reasons. It is not due to a medical problem. When your child holds stool much longer than normal, this can cause the stool to become harder and packed (impacted) in the rectum. As a result, your child may have difficulties in passing stool. The study drug was approved in the United States in 2018 to treat adults with constipation. It is now being looked at in children with functional constipation.
- All genders
- All Ages
- Healthy Volunteers
- In Person
- Paid
Who can participate?
Gender: All genders
Age: All Ages
Volunteers: Healthy Volunteers
Location: In Person
Inclusion Criteria
- Toilet-trained children 3 years to 17 years of age, or non-toilet-trained subjects 6 months to 17 years of age
- Subject weighs at least 5.5 kg (12 lbs) or more
- Male, or non-pregnant, non-lactating female subjects - if you sexually active these individuals must agree to comply use of approved contraceptive
Will I be paid for my time?
Yes
IRB#: IRB_00141463
PI: Molly O'Gorman
Department: PEDIATRICS
Approval Date: 2022-04-06 06:00:00
Specialties: Gastroenterology