NCT02559206

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 759 (actual)
• Sponsor: Ironwood Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Irritable Bowel Syndrome With Constipation

Interventions

Type	Name	Description
DRUG	Linaclotide	Oral, once daily
DRUG	Matching Placebo	Oral, once daily

Timeline

• Start date: 2015-10-22
• Primary completion: 2016-09-30
• Completion: 2016-09-30
• First posted: 2015-09-24
• Last updated: 2020-04-24
• Results posted: 2020-04-24

Locations

71 sites across 1 country: United States