Constipation Study - Children 6-17

STUDY BASICS

Does your child aged 6-17 struggle with constipation? 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 constipation. Reimbursement may be provided.

STUDY PURPOSE

Constipation in children is a common problem. Children who are constipated may have infrequent bowel movements, and have dry, hard stools that are painful to pass. The purpose of this study is to find out if an investigational drug is safe and effective for children with constipation.

COULD THIS STUDY BE RIGHT FOR YOUR CHILD?

• Ages 6-17
• In relatively good health
• During the past 2 months: - Has 2 or fewer bowel movements per week - Has painful or hard bowel movements

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 possible doses or placebo. The placebo looks and tastes just like the investigational drug but does not contain any active drug.