Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to 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 purpose of this study is to determine the safety, efficacy, and dose response of a range of oral doses of linaclotide administered to patients meeting criteria for IBS-C.

Key facts

Study ID

NCT00460811

Run by

Ironwood Pharmaceuticals, Inc.

People needed

420

Starts

2007-04-01

Expected to finish

2008-04-01

Last updated by the study team

2013-02-04

Who can join

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

You may qualify if…

• Must not be pregnant or breastfeeding and agree to use birth control;
• Completion of a negative colonoscopy as per American Gastroenterology Association (AGA) criteria and no clinically-significant laboratory or physical examination findings;
• Meets protocol-defined criteria for IBS-C, including stool frequency, straining, stool consistency, abdominal pain, and abdominal discomfort criteria;
• Demonstrates English fluency and has access to a touch-tone telephone.

You may not qualify if…

• Recent history of mushy or watery stools;
• Various medical conditions, medical histories, or family medical histories that would not make the patient a good candidate for the study;
• Clinically-significant alarm symptoms;
• Secondary causes of constipation or evacuation disorders;
• Surgery to the gastrointestinal tract;
• Usage of prohibited medications.

Where it is running

• Microbia Investigational Site — Chandler, Arizona, United States
• Microbia Investigational Site — Tuscon, Arizona, United States
• Microbia Investigational Site — Sherwood, Arkansas, United States
• Microbia Investigational Site — Anaheim, California, United States
• Microbia Investigational Site — Garden Grove, California, United States
• Microbia Investigational Site — Sacramento, California, United States
• Microbia Investigational Site — San Diego, California, United States
• Microbia Investigational Site — Bristol, Connecticut, United States
• Microbia Investigational Site — Boynton Beach, Florida, United States
• Microbia Investigational Site — Dunedin, Florida, United States
• Microbia Investigational Site — Largo, Florida, United States
• Microbia Investigational Site — Ocala, Florida, United States
• Microbia Investigational Site — Port Orange, Florida, United States
• Microbia Investigational Site — Stuart, Florida, United States
• Microbia Investigational Site — Tampa, Florida, United States
• Microbia Investigational Site — Stockbridge, Georgia, United States
• Microbia Investigational Site — Libertyville, Illinois, United States
• Microbia Investigational Site — Peoria, Illinois, United States
• Microbia Investigational Site — Clive, Iowa, United States
• Microbia Investigational Site — Davenport, Iowa, United States
• Microbia Investigational Site — Mission, Kansas, United States
• Microbia Investigational Site — Shawnee, Kansas, United States
• Microbia Investigational Site — Baton Rouge, Louisiana, United States
• Microbia Investigational Site — Monroe, Louisiana, United States
• Microbia Investigational Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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