This study is evaluating the safety and effectiveness of a study medication, called prucalopride, for children and teenagers with constipation. Prucalopride has already been approved in the United States for the treatment of constipation in adults.
The study is divided into three phases:
Phase One
Screening
This phase is devoted to determining if your child is eligible to participate in the study.
Phase Two
Study Treatment
If your child is eligible to participate in the 2Go Study, they will begin the Study Treatment Phase, which is broken into two parts, Part A and Part B.
- For Part A, which lasts for 12 weeks, your child will be randomly assigned to 1 of 3 study treatment groups: high dose, low dose, and placebo
- After Part A is completed, study participants who were in the placebo group for 12 weeks will be re-randomized into either the high- or low-dose group for Part B of the Study Treatment Phase, which lasts for 36 weeks
- Part B of the Study Treatment Phase will measure the long-term safety of the study medication
Phase Three
Follow-up Phase
After Part A and Part B of the Study Treatment Phase are completed, there will be one follow-up visit to complete the study that takes place approximately 4 weeks after the last dose of the study medication is taken.