Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating
Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating
The purpose of this study is to evaluate the efficacy and safety of linaclotide compared with
 placebo in patients with chronic constipation (CC) and prominent abdominal bloating. This
 study includes an up to 3-week screening period and a 2-3 week pretreatment period. Patients
 who are eligible will be randomized to one of two doses of linaclotide or placebo for 12
 weeks. This 12-week study will assess the effects of linaclotide on bowel movement frequency,
 as well as other abdominal and bowel symptoms of CC.
Inclusion Criteria:

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

 -  Patient has successfully completed protocol procedures (with no clinically significant
 findings)

 -  Patient meets protocol criteria for Chronic Constipation(CC): < 3 bowel movements per
 week and reports one or more of the following symptoms for at least 12 weeks:

 1. Straining during more than 25% of BMs

 2. Lumpy or hard stools during more than 25% of BMs

 3. Sensation of incomplete evacuation during more than 25% of BMs

 -  Patient demonstrates continued chronic constipation and bloating through Pretreatment
 Period

 -  Patient is compliant with Interactive voice response System (IVRS)

 Exclusion Criteria:

 -  Patient has a 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 would limit the patient's ability to complete or participate in this
 clinical trial or could confound the study assessments