Offered by: Nemours Children's Health, Jacksonville
Location: Jacksonville, Fla.
Linaclotide Safety and Efficacy Functional Constipation (FC)
What is the trial about?
The purpose of this study is to look into the safety and efficacy of linaclotide in the treatment of functional constipation (constipation without a known cause) in children 6-17 years of age.
Who can participate?
Children 6 to 17 years of age with functional constipation.
What is involved?
There will be a total of 8 study visits over a period of up to 20 weeks. The study staff will tell you about the study visit schedule and how long each visit will last. You may need to attend additional unscheduled visits for safety or other reasons.
You will be asked to provide information about yourself, such as name, date of birth, and race. We will ask you to tell us about your health and any medications that you take. We will measure your height, weight, and vital signs. We will ask you to provide blood and urine samples and complete an electrocardiogram of your heart. You would have a physical examination performed by the study doctor. There will be a fecal impaction assessment. You would be provide an electronic diary to complete questionnaires about you and your health.