Long-Term Safety of Linaclotide in Pediatric Participants With Functional Constipation

Clinical Trial

Offered by: Nemours Children's Health, Jacksonville
Location: Jacksonville, Fla.

Trial Name

Long-Term Safety of Linaclotide in Pediatric Participants With Functional Constipation (FC).

What is the trial about?

The purpose of this research is to look into the safety of linaclotide in the treatment of functional constipation (constipation without a known cause) and irritable bowel syndrome with constipation (IBS-C).

Who can participate?

This research study is looking for at least 120 children ages 6-17 years with functional constipation and children ages 7-17 years with irritable bowel syndrome with constipation (IBS-C) who have completed treatment in one of the linaclotide lead in studies (LIN-MD-62, LIN-MD-63 or LIN-MD-64).

What is involved?

You will be asked to sign a consent form. You will be asked questions about your health. You will have a physical exam and your height measured. We will check your vital signs, give you an electrocardiogram, and do a fecal impaction assessment. Two times during the study we will collect blood and urine samples. Female participants will have a urine pregnancy test done at every visit.

• If you have functional constipation, you will have a total of seven study visits over a period of approximately 26 weeks.
• If you have ISB-C you will have a total of 10 study visits over a period of approximately 54 weeks.