NCT01880424

A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,722 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial comparing one dose of linaclotide to placebo. Approximately 800 patients with a diagnosis of IBS-C (modified Rome III criteria) will be randomized at up to 60 trial centers in China, Australia, and New Zealand. The trial will consist of up to 21 days of screening, 14 to 21 days of pre-treatment, 12 weeks of double-blind treatment, and 2 weeks of follow-up. At the end of the Pre-treatment Period, patients meeting the entry criteria for this trial will be randomized to one of two double-blind treatment groups: 290 ug linaclotide, or placebo (1:1).

Conditions

• Irritable Bowel Syndrome With Constipation (IBS-C)

Interventions

Type	Name	Description
DRUG	Placebo	matching Placebo Capsules, Oral, once daily
DRUG	Linaclotide	Linaclotide 290 ug Capsules, Oral, once daily

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2013-06-19
• Last updated: 2016-09-27
• Results posted: 2016-09-27

Locations

82 sites across 5 countries: United States, Australia, Canada, China, New Zealand