Research Study for Children and Teens with IBS with Constipation (IBS-C)
What is the PRIME Study?
The PRIME Study is a 12-week research study to see if an investigational drug is safe and effective in treating Irritable Bowel Syndrome with Constipation (IBS-C) in children and teens. The study will compare the investigational drug with a placebo (a pill or liquid that looks like the investigational drug but has no drug in it).
Who can participate?
Pediatric and adolescent patients age 7-17 who have symptoms of IBS with constipation may be eligible to participate.
Why should my child participate?
By participating in this study, your child will help researchers gather important information on the investigational drug and IBS-C. Qualified participants will receive:
- Investigational drug or placebo at no cost
- Study-related medical care at no cost
Compensation may be provided for time and travel
What will my child be asked to do?
If your child qualifies, you will be involved in the study for up to 12 weeks. Your child will be randomly assigned (like flipping a coin) into a treatment group. Patients age 7-11 will take a liquid or capsule medication (or placebo), and patients age 12-17 will take a capsule medication (or placebo). Your child will need to attend 6 appointments with the study team. During these visits, the study team will:
- Talk with you and your child about symptoms and any changes since the last visit
- Ask about any other medications your child may have taken
- Conduct a physical exam
- Check weight and vital signs (e.g. blood pressure, temperature, pulse)
- Collect urine or blood for study-related lab tests
- Administer study surveys and questionnaires
You and your child will also be asked to collect information every day at home during the study period on a handheld electronic diary provided to you.
To see if your child may be eligible call 1-877-899-1391 or visit www.pediatricibscstudy.com.
If your child has been diagnosed with IBS-C, or suffers from IBS-C symptoms, and is 7 to 17 years old, he/she may be eligible to participate.
Please call 1-877-899-1391 for further information or visit www.pediatricibscstudy.com.