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

Completed · Phase 3 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome With Constipation

In brief

The purpose of this study is to determine the safety and efficacy of linaclotide administered to patients with Irritable Bowel Syndrome with Constipation (IBS-C).

Key facts

Study ID

NCT00938717

Run by

Ironwood Pharmaceuticals, Inc.

People needed

805

Starts

2009-07-01

Expected to finish

2010-09-01

Last updated by the study team

2013-11-05

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 diagnosis of IBS-C
• Patient demonstrates continued IBS-C 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 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 — Anaheim, California, United States
• Ironwood Investigational Site — Chula Vista, California, United States
• Ironwood Investigational Site — Encinitas, California, United States
• Ironwood Investigational Site — Garden Grove, California, United States
• Ironwood Investigational Site — Laguna Hills, California, United States
• Ironwood Investigational Site — Orange, California, United States
• Ironwood Investigational Site — San Carlos, California, United States
• Ironwood Investigational Site — San Diego, California, United States
• Ironwood Investigational Site — San Diego, California, United States
• Ironwood Investigational Site — San Diego, California, United States
• Ironwood Investigational Site — Colorado Springs, Colorado, United States
• Ironwood Investigational Site — Bristol, Connecticut, United States
• Ironwood Investigational Site — Boynton Beach, Florida, United States
• Ironwood Investigational Site — Hollywood, Florida, United States
• Ironwood Investigational Site — Inverness, Florida, United States
• Ironwood Investigational Site — Jacksonville, Florida, United States
• Ironwood Investigational Site — Jacksonville, Florida, United States
• Ironwood Investigational Site — Lauderdale Lakes, Florida, United States
• Ironwood Investigational Site — Miami, Florida, United States
• Ironwood Investigational Site — Pinellas Park, Florida, United States
• Ironwood Investigational Site — Tampa, Florida, United States
• Ironwood Investigational Site — Newnan, Georgia, United States
• Ironwood Investigational Site — Peoria, Illinois, United States
• Ironwood Investigational Site — Anderson, Indiana, United States
• Ironwood Investigational Site — Sherwood, Arkansas, United States

Full record on ClinicalTrials.gov

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