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

Irritable Bowel Syndrome With Constipation Clinical Trial

Official title:
A Phase 2b, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group, Dose-range-finding Study of Two Delayed Release Formulations of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02559206
Study type Interventional
Source Ironwood Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 2
Start date October 22, 2015
Completion date September 30, 2016
View Details
See also
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