Offered by: Nemours Children's Health, Jacksonville
Location: Jacksonville, Fla.
Long-Term Safety of Linaclotide in Pediatric Participants With Functional Constipation (FC).
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).
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).
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.
Trial Name: Long-Term Safety of Linaclotide in Pediatric Participants With Functional Constipation (FC).
IRB#: 1505456
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