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

Completed · Phase 3 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome Characterized by Constipation

In brief

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.

Key facts

Study ID

NCT00948818

Run by

Forest Laboratories

People needed

803

Starts

2009-07-01

Expected to finish

2010-08-01

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 meets protocol criteria for IBS: reports abdominal discomfort or pain that has two or more of the following three features:
• Relieved with defecation
• Onset associated with a change in frequency of stool
• 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

You may not qualify if…

• 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

Where it is running

• Forest Investigative Site 036 — Birmingham, Alabama, United States
• Forest Investigative Site 135 — Hueytown, Alabama, United States
• Forest Investigative Site 014 — Huntsville, Alabama, United States
• Forest Investigative Site 080 — Chandler, Arizona, United States
• Forest Investigative Site 053 — Mesa, Arizona, United States
• Forest Investigative Site 078 — Peoria, Arizona, United States
• Forest Investigative Site 101 — Phoenix, Arizona, United States
• Forest Investigative Site 128 — Phoenix, Arizona, United States
• Forest Investigative Site 051 — Scottsdale, Arizona, United States
• Forest Investigative Site 136 — Tucson, Arizona, United States
• Forest Investigative Site 087 — Tucson, Arizona, United States
• Forest Investigative Site 094 — Burbank, California, United States
• Forest Investigative Site 026 — Encinitas, California, United States
• Forest Investigative Site 096 — Foothill Ranch, California, United States
• Forest Investigative Site 057 — Los Angeles, California, United States
• Forest Investigative Site 097 — Mission Hills, California, United States
• Forest Investigative Site 005 — Orange, California, United States
• Forest Investigative Site 024 — Westlake Village, California, United States
• Forest Investigative Site 021 — Boulder, Colorado, United States
• Forest Investigative Site 019 — Colorado Springs, Colorado, United States
• Forest Investigative Site 034 — Denver, Colorado, United States
• Forest Investigative Site 074 — Longmont, Colorado, United States
• Forest Investigative Site 010 — Wheat Ridge, Colorado, United States
• Forest Investigative Site 058 — Waterbury, Connecticut, United States
• Forest Investigative Site 037 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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