NCT00938717

Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide Administered Orally for 26 Weeks in Patients With Irritable Bowel Syndrome With Constipation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 805 (actual)
• Sponsor: Ironwood Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and efficacy of linaclotide administered to patients with Irritable Bowel Syndrome with Constipation (IBS-C).

Conditions

• Irritable Bowel Syndrome With Constipation

Interventions

Type	Name	Description
DRUG	Linaclotide or Matching Placebo	Linaclotide or Matching Placebo, administered orally, once daily, for the duration of the trial

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2009-07-14
• Last updated: 2013-11-05
• Results posted: 2013-01-30

Locations

107 sites across 1 country: United States