An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

Completed · Phase 3

Conditions studied: Irritable Bowel Syndrome With Constipation, Chronic Constipation

In brief

The objective of this study is to assess the long-term safety of linaclotide administered to patients with chronic constipation (CC) or irritable bowel syndrome with constipation (IBS-C).

Key facts

Study ID

NCT00730171

Run by

Ironwood Pharmaceuticals, Inc.

People needed

1743

Starts

2008-09-01

Expected to finish

2012-03-01

Last updated by the study team

2018-02-19

Who can join

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

You may qualify if…

• Patients must have
• entered study MCP-103-303 or MCP-103-302 and at minimum completed the pre-treatment period or
• completed one of the following studies: MCP-103-004, MCP-103-005, MCP-103-201, MCP-103-202
• Sexually active patients of childbearing potential agree to use birth control
• Females of childbearing potential must have a negative urine pregnancy test prior to dosing
• Lactating females must agree not to breastfeed
• Patient must meet protocol criteria for CC or IBS-C

You may not qualify if…

• Patient must not use protocol-defined prohibited medicine
• Patient is planning to receive an investigational drug at any time during the study
• Patient has an unresolved adverse events or a clinically significant finding on a physical examination, 12-lead electrocardiogram, or clinical laboratory test

Where it is running

• Ironwood Investigational Site — Huntsville, Alabama, United States
• Ironwood Investigational Site — Chandler, Arizona, United States
• Ironwood Investigational Site — Phoenix, Arizona, United States
• Ironwood Investigational Site — Tucson, Arizona, United States
• Ironwood Investigational Site — Tucson, Arizona, United States
• Ironwood Investigational Site — Tucson, Arizona, United States
• Ironwood Investigational Site — Sherwood, Arkansas, United States
• 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 — Los Angeles, California, United States
• Ironwood Investigational Site — Orange, California, United States
• Ironwood Investigational Site — Sacramento, 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 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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