Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Completed · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome With Constipation

In brief

The objectives of this study are to evaluate the safety, efficacy, and dose response of two delayed release formulations of linaclotide (DR; DR formulation 1 is DR1; DR formulation 2 is DR2) administered orally to patients with irritable bowel syndrome with constipation (IBS-C). Additional objectives include understanding how the two DR formulations compare with each other and with the FDA-approved 290 μg LINZESS® (the immediate release \[IR\] formulation of linaclotide).

Key facts

Study ID

NCT02559206

Run by

Ironwood Pharmaceuticals, Inc.

People needed

759

Starts

2015-10-22

Expected to finish

2016-09-30

Last updated by the study team

2020-04-24

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 American Gastroenterological Association (AGA) criteria, with no clinically significant findings
• Patient has no clinically significant findings on a physical examination and clinical laboratory tests
• Patient meets protocol criteria for diagnosis of IBS-C
• Patient demonstrates continued IBS-C through Pretreatment Period
• Patient maintains a minimum level of compliance with daily diary

You may not qualify if…

• Patient has history of loose or watery stools
• Patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain
• 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

• Ironwood Investigational Site — Phoenix, Arizona, United States
• Ironwood Investigational Site — Tucson, Arizona, United States
• Ironwood Investigational Site — North Little Rock, Arkansas, United States
• Ironwood Investigational Site — Anaheim, California, United States
• Ironwood Investigational Site — Chula Vista, California, United States
• Ironwood Investigational Site — Garden Grove, California, United States
• Ironwood Investigational Site — La Mesa, California, United States
• Ironwood Investigational Site — Newport Beach, California, United States
• Ironwood Investigational Site — Orange, California, United States
• Ironwood Investigational Site — San Diego, California, United States
• Ironwood Investigational Site — Thousand Oaks, California, United States
• Ironwood Investigational Site — Colorado Springs, Colorado, United States
• Ironwood Investigational Site — Bristol, Connecticut, United States
• Ironwood Investigational Site — Waterbury, Connecticut, United States
• Ironwood Investigational Site — Hialeah, Florida, United States
• Ironwood Investigational Site — Kissimmee, Florida, United States
• Ironwood Investigational Site — Miami, Florida, United States
• Ironwood Investigational Site — Miami, Florida, United States
• Ironwood Investigational Site — Miami, Florida, United States
• Ironwood Investigational Site — Miami, Florida, United States
• Ironwood Investigational Site — Orlando, Florida, United States
• Ironwood Investigational Site — South Miami, Florida, United States
• Ironwood Investigational Site — Tampa, Florida, United States
• Ironwood Investigational Site — West Palm Beach, Florida, United States
• Ironwood Investigational Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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