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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.

I AM INTERESTED

  • 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

For more information contact:

Richard Drake

richard.drake@hsc.utah.edu

  801-213-8678

IRB#: IRB_00141463

PI: Molly O'Gorman

Department: PEDIATRICS

Approval Date: 2022-04-06 06:00:00

Specialties: Gastroenterology

Last Updated: 6/8/23