Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ironwood Pharmaceuticals, Inc.
• Treatments: Linaclotide

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.