Irritable Bowel Syndrome with Constipation Study – Children Ages 7-17

STUDY BASICS

Does your child aged 7-17 struggle with constipation and abdominal pain? If so, your child may be able to take part in a research study to find out if an investigational drug is safe and effective for children with Irritable Bowel Syndrome with Constipation (IBS-C). Reimbursement may be provided.

STUDY PURPOSE

Constipation in children is a common problem. Children who are constipated may experience abdominal discomfort or pain, have infrequent bowel movements, and have dry, hard stools that are painful to pass. Irritable Bowel Syndrome with Constipation (IBS-C) may be diagnosed when a child regularly experiences these symptoms over a period of time. The purpose of this study is to find out if an investigational drug is safe and effective for children with Irritable Bowel Syndrome with Constipation (IBS-C).

COULD THIS STUDY BE RIGHT FOR YOUR CHILD?

• Ages 7-17
• In relatively good health
• During the past 2 months: - Has 2 or fewer bowel movements per week - Has painful or hard bowel movements
• Has had abdominal pain or discomfort associated with the following at least some of the time: - Improvement with bowel movements - Onset with a change in how often bowel movements occur - Onset with a change in bowel movement form or appearance

WHAT PARTICIPANTS CAN EXPECT

Participation involves six visits over 9-12 weeks. Participants will have exams and lab tests, and will be asked to complete an online diary twice each day (parent or child may complete the diary). It is important to know that children who participate in this study will be randomly assigned (like the flip of a coin) to receive either the investigational drug at 3 or 4 doses or placebo. The placebo looks and tastes just like the investigational drug but does not contain any active drug.