Overview

Trial of Linaclotide in Patients With Chronic Constipation

Status:
Completed
Trial end date:
2009-10-01
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 chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each dosing group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ironwood Pharmaceuticals, Inc.
Collaborator:
Forest Laboratories
Treatments:
Linaclotide
Criteria
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