Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Constipation

In brief

The primary purpose of this study is to evaluate the efficacy and safety of administration of linaclotide acetate in patients with chronic constipation.

Key facts

Study ID

NCT00402337

Run by

Ironwood Pharmaceuticals, Inc.

People needed

310

Starts

2006-11-01

Expected to finish

2008-02-01

Last updated by the study team

2013-03-05

Who can join

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

You may qualify if…

• Patient is 18 years of age or older
• Patient meets colonoscopy requirements according to the American Gastroenterological Association
• Patient meets criteria for chronic constipation including weekly bowel movement frequency requirements and reports one or more symptoms of constipation according to protocol requirements
• Patient has successfully completed study requirements with no clinically-significant findings: physical exam, ECG, clinical laboratory tests
• Patient is fluent in English

You may not qualify if…

• Patient reports loose or watery stools
• Patient meets criteria for IBS including protocol-defined abdominal discomfort or pain
• Patient may not take prohibited medications per protocol
• Medical diagnoses, medical conditions, or family history that would not make the patient a good candidate for the study or limit the patient's ability to complete the clinical study

Where it is running

• Microbia Investigational Site — Tucson, Arizona, United States
• Microbia Investigational Site — Sherwood, Arkansas, United States
• Microbia Investigational Site — Anaheim, California, United States
• Microbia Investigational Site — Sacramento, California, United States
• Microbia Investigational Site — San Diego, California, United States
• Microbia Investigational Site — Boulder, Colorado, United States
• Microbia Investigational Site — Bristol, Connecticut, United States
• Microbia Investigational Site — Boynton Beach, Florida, United States
• Microbia Investigational Site — Port Orange, Florida, United States
• Microbia Investigational Site — Tampa, Florida, United States
• Microbia Investigational Site — Stockbridge, Georgia, United States
• Microbia Investigational Site — Peoria, Illinois, United States
• Microbia Investigational Site — Indianapolis, Indiana, United States
• Microbia Investigational Site — Clive, Iowa, United States
• Microbia Investigational Site — Davenport, Iowa, United States
• Microbia Investigational Site — Louisville, Kentucky, United States
• Microbia Investigational Site — Monroe, Louisiana, United States
• Microbia Investigational Site — Silver Spring, Maryland, United States
• Microbia Investigational Site — Boston, Massachusetts, United States
• Microbia Investigational Site — Ann Arbor, Michigan, United States
• Microbia Investigational Site — Traverse City, Michigan, United States
• Microbia Investigational Site — Olive Branch, Mississippi, United States
• Microbia Investigational Site — Lincoln, Nebraska, United States
• Microbia Investigational Site — Great Neck, New York, United States
• Microbia Investigational Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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