NCT00460811

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

A Randomized, Multicenter, Double-blind, Placebo-controlled, Dose-range-finding, Parallel-design, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Irritable Bowel Syndrome With Constipation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 420 (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, efficacy, and dose response of a range of oral doses of linaclotide administered to patients meeting criteria for IBS-C.

Conditions

• Irritable Bowel Syndrome With Constipation

Interventions

Type	Name	Description
DRUG	Linaclotide Acetate	Oral, once daily
DRUG	Matching placebo	Oral, once daily

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-02-01
• Completion: 2008-04-01
• First posted: 2007-04-16
• Last updated: 2013-02-04
• Results posted: 2013-01-30

Locations

85 sites across 2 countries: United States, Canada