Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with irritable bowel syndrome with constipation (IBS-C).

The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Collaborator: Ironwood Pharmaceuticals, Inc.
• Treatments: Linaclotide

Criteria

Inclusion Criteria:

• Patient meets protocol criteria for IBS: reports abdominal discomfort or pain that has two or more of the following three features:

1. Relieved with defecation

2. Onset associated with a change in frequency of stool

3. Onset associated with a change in form (appearance) of stool

• Patient reports < 3 bowel movements (BMs) per week (in the absence of any laxative, suppository, or enema use during the preceding 24 hours) and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during > 25% of BMs

• Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests (some patients may require a colonoscopy per American Gastroenterological Association (AGA) guidelines)

• Patient is compliant with Interactive Voice Response System (IVRS) for daily diary reporting of BM habits and IBS symptoms

Exclusion Criteria:

• Patient has history of loose or watery stools for >25% of BMs

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

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