Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Status:
Completed
Trial end date:
2016-09-30
Target enrollment:
Participant gender:
Summary
The objectives of this study are to evaluate the safety, efficacy, and dose response of two
delayed release formulations of linaclotide (DR; DR formulation 1 is DR1; DR formulation 2 is
DR2) administered orally to patients with irritable bowel syndrome with constipation (IBS-C).
Additional objectives include understanding how the two DR formulations compare with each
other and with the FDA-approved 290 μg LINZESS® (the immediate release [IR] formulation of
linaclotide).