Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Phase 2 Completed 759 enrolled Ironwood Pharmaceuticals, Inc. Forest Laboratories · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objectives of this study are to evaluate the safety, efficacy, and dose response of two delayed release formulations of linaclotide (DR; DR formulation 1 is DR1; DR formulation 2 is DR2) administered orally to patients with irritable bowel syndrome with constipation (IBS-C). Additional objectives include understanding how the two DR formulations compare with each other and with the FDA-approved 290 μg LINZESS® (the immediate release \[IR\] formulation of linaclotide).

Timeline

Start: 2015-10-22
Primary completion: 2016-09-30
Completion: 2016-09-30

Outcome

Mixed primary results

registry analysis (superiority test); Placebo vs Linaclotide DR1 300 μg; p = 0.0199; LS Mean Difference (Lin-Placebo) -0.771 (95% CI -1.419 to -0.123); MMRM NCT02559206 ↗

registry analysis (superiority test); Placebo vs Linaclotide DR2 300 μg; p = 0.4333; LS Mean Difference (Lin-Placebo) -0.258 (95% CI -0.905 to 0.389); MMRM NCT02559206 ↗

Publications

Chey WD, Sayuk GS, Bartolini W, Reasner DS, Fox SM, Bochenek W, Boinpally R, Shea E, Tripp K, Borgstein N. Randomized Trial of 2 Delayed-Release Formulations of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation. Am J Gastroenterol. 2021 Feb 1;116(2):354-361. doi: 10.14309/ajg.0000000000000967.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Linaclotide	Peptide	30 ug	Oral
Subject	Linaclotide	Peptide	100 ug	Oral
Subject	Linaclotide	Peptide	290 ug	Oral
Subject	Linaclotide	Peptide	300 ug	Oral