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)

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).

Timeline

Start

2013-07

Primary completion

2015-05

Completion

2015-05

Outcome

Met primary endpoint

registry Linaclotide Arm vs Placebo Arm; p = 0.0010; Odds Ratio (OR) 1.59 (95% CI 1.21 to 2.09) NCT01880424 ↗

registry Linaclotide Arm vs Placebo Arm; p <0.0001; Odds Ratio (OR) 2.56 (95% CI 1.83 to 3.58) NCT01880424 ↗

Publications

• Peng LH, Fang JY, Dai N, Shen XZ, Yang YL, Sun J, Yang YS. Efficacy and safety of linaclotide in patients with irritable bowel syndrome with constipation: Chinese sub-cohort analysis of a phase III, randomized, double-blind, placebo-controlled trial. J Dig Dis. 2022 Feb;23(2):99-110. doi: 10.1111/1751-2980.13081.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Linaclotide	Peptide	290 ug	Oral

Indications