Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Constipation

In brief

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

Key facts

Study ID

NCT00765882

Run by

Forest Laboratories

People needed

633

Starts

2008-09-01

Expected to finish

2009-08-01

Last updated by the study team

2013-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Forest Investigative Site — Birmingham, Alabama, United States
• Forest Investigative Site — Huntsville, Alabama, United States
• Forest Investigative Site — Chandler, Arizona, United States
• Forest Investigative Site — Mesa, Arizona, United States
• Forest Investigative Site — Peoria, Arizona, United States
• Forest Investigative Site — Phoenix, Arizona, United States
• Forest Investigative Site — Scottsdale, Arizona, United States
• Forest Investigative Site — Tucson, Arizona, United States
• Forest Investigative Site — Burbank, California, United States
• Forest Investigative Site — Encinitas, California, United States
• Forest Investigative Site — Foothill Ranch, California, United States
• Forest Investigative Site — Los Angeles, California, United States
• Forest Investigative Site — Orange, California, United States
• Forest Investigative Site — Westlake Village, California, United States
• Forest Investigative Site — Boulder, Colorado, United States
• Forest Investigative Site — Colorado Springs, Colorado, United States
• Forest Investigative Sites — Denver, Colorado, United States
• Forest Investigative Site — Longmont, Colorado, United States
• Forest Investigative Site — Wheat Ridge, Colorado, United States
• Forest Investigative Site — Waterbury, Connecticut, United States
• Forest Investigative Site — Boca Raton, Florida, United States
• Forest Investigative Site — Bradenton, Florida, United States
• Forest Investigative Site — Brooksville, Florida, United States
• Forest Investigative Site — Fort Myers, Florida, United States
• Forest Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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