A Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide 290 μg Administered Orally for 12 Weeks Followed by a 4-week Randomized Withdrawal Period in Patients With Irritable Bowel Syndrome With Constipation
A Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide 290 μg Administered Orally for 12 Weeks Followed by a 4-week Randomized Withdrawal Period in Patients With Irritable Bowel Syndrome With Constipation
To evaluate the efficacy on abdominal symptoms (abdominal bloating, abdominal discomfort, and abdominal pain) and safety of linaclotide 290 μg administered orally to patients with IBS-C.
This study consists of a 12-week Treatment Period followed by 4-week Randomized Withdrawal (RW) Period.
Inclusion Criteria:
Patient has no clinically significant findings on a physical examination and clinical laboratory tests
Female patients of childbearing potential must agree to use one of the following methods of birth control:
Patient meets protocol criteria for diagnosis of IBS-C
Patient demonstrates continued IBS-C symptoms through Pretreatment Period
Patient maintains a minimum level of compliance with daily diary
Exclusion Criteria: