NCT00948818

Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks Followed by a 4-Week Randomized Withdrawal Period in Patients With Irritable Bowel Syndrome With Constipation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 803 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with irritable bowel syndrome with constipation (IBS-C). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder.

Conditions

• Irritable Bowel Syndrome Characterized by Constipation

Interventions

Type	Name	Description
DRUG	Linaclotide 290 micrograms	Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study
DRUG	Matching placebo	Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-07-01
• Completion: 2010-08-01
• First posted: 2009-07-29
• Last updated: 2013-01-30
• Results posted: 2013-01-30

Locations

118 sites across 2 countries: United States, Canada