Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
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).
Inclusion Criteria:

 -  Patient has completed a colonoscopy according to the American Gastroenterological
 Association (AGA) criteria, with no clinically significant findings

 -  Patient has no clinically significant findings on a physical examination and clinical
 laboratory tests

 -  Patient meets protocol criteria for diagnosis of IBS-C

 -  Patient demonstrates continued IBS-C through Pretreatment Period

 -  Patient maintains a minimum level of compliance with daily diary

 Exclusion Criteria:

 -  Patient has history of loose or watery stools

 -  Patient has symptoms of or been diagnosed with a medical condition that may contribute
 to abdominal pain

 -  Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease
 or condition that can affect GI motility

 -  Patient has any protocol-excluded or clinically significant medical or surgical
 history that could confound the study assessments