Trial of Linaclotide in Patients With Chronic Idiopathic Constipation

Inclusion Criteria

• •Patient has completed a colonoscopy if one is needed 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 CIC: reports \< 3 bowel movements (BMs) per week and reports one or more of the following during ≥ 25% of BMs: straining, lumpy or hard stools, sensation of incomplete evacuation during the 3 months before the diagnosis with the onset at least 6 months before the diagnosis
• •Patient is compliant with daily interactive voice response system (IVRS) calls
• •Patient reports an average of \< 3 complete spontaneous BMs (CSBMs) and ≤ 6 SBMs per week by the IVRS over the 14 calendar days before the Randomization Visit and the calendar day of Randomization.