At a glance
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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)
In Brief
A Phase 3 clinical trial evaluating Placebo and Linaclotide for Irritable Bowel Syndrome With Constipation (IBS-C). Completed, enrolled 1,722 participants across 82 sites in 5 countries.
Detailed 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).
Study Details
Timeline
Interventions
matching Placebo Capsules, Oral, once daily
Linaclotide 290 ug Capsules, Oral, once daily