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: Chronic Constipation, Irritable Bowel Syndrome With 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

NCT00765999

Run by

Forest Laboratories

People needed

1559

Starts

2008-10-31

Expected to finish

2012-01-31

Last updated by the study team

2019-02-15

Who can join

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

You may qualify if…

• Patients must have
• entered study LIN-MD 01[NCT00765882] or LIN-MD-31 [NCT00948818] and at minimum completed the pre-treatment period or
• completed one of the following studies: MCP-103-004 [NCT00306748], MCP-103-005 [NCT00258193], MCP-103-201 [NCT00402337], MCP-103-202 [NCT00460811]
• 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 AE or a clinically significant finding on a physical examination, 12-lead ECG, or clinical laboratory test

Where it is running

• Parkway Medical Center — Birmingham, Alabama, United States
• Medical Affiliated Research Center, Inc. — Huntsville, Alabama, United States
• Radiant Research, Inc. — Chandler, Arizona, United States
• Pivotal Research Centers — Peoria, Arizona, United States
• Pivotal Research Center — Peoria, Arizona, United States
• Carl T Hayden VA Medical Center GI Section-CS-111G — Phoenix, Arizona, United States
• Elite Clinical Studies, LLC — Phoenix, Arizona, United States
• Radiant Research, Inc. — Scottsdale, Arizona, United States
• Genova Clinical Research, Inc. — Tucson, Arizona, United States
• Adobe Clinical Research, LLC — Tucson, Arizona, United States
• Providence Clinical Research — Burbank, California, United States
• Encompass Clinical Research North Coast — Encinitas, California, United States
• Family Medical Center — Foothill Ranch, California, United States
• Axis Clinical Trials — Los Angeles, California, United States
• Facey Medical Foundation — Mission Hills, California, United States
• Advanced Clinical Research Institute — Orange, California, United States
• Westlake Medical Research — Westlake Village, California, United States
• Boulder Medical Center, P.C. — Boulder, Colorado, United States
• Lynn Institute of the Rockies — Colorado Springs, Colorado, United States
• Colorado Gastroenterology, Prof LLC — Denver, Colorado, United States
• Longmont Medical Research Network — Longmont, Colorado, United States
• Western States Clinical Research — Wheat Ridge, Colorado, United States
• Chase Medical Research, LLC — Waterbury, Connecticut, United States
• Clinical Trials Management of Boca Raton, Inc. — Boca Raton, Florida, United States
• Innovative Clinical Trials — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.