Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation
Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation
The objective of this trial is to determine the efficacy and safety of linaclotide
 administered to patients with chronic constipation (CC). The primary efficacy parameter is
 the percentage of patients in each treatment group that meet the protocol definition for
 Complete Spontaneous Bowel Movement (CSBM) Overall Responder
Inclusion Criteria:

 -  Patient has completed a colonoscopy according to the AGA criteria, with no clinically
 significant findings

 -  Patient has successfully completed protocol procedures (with no clinically significant
 findings): physical exam, 12-lead ECG, or clinical laboratory tests

 -  Patient meets protocol criteria for CC: reports < 3 bowel movements per week and
 reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation
 during > 25% of BMs

 -  Patient demonstrates continued chronic constipation through Pretreatment Period

 -  Patient is compliant with IVRS

 Exclusion Criteria:

 -  Patient has history of loose or watery stools

 -  Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS)

 -  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