Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Summary

The purpose of this study is to determine the safety, efficacy, and dose response of a range of oral doses of linaclotide administered to patients meeting criteria for IBS-C.

Timeline

Start

2007-04

Primary completion

2008-02

Completion

2008-04

Publications

• Lembo A, Kuo B, Boinpally R, Li E, Mallick M, Bochenek W, Bartolini W. Randomised clinical trial: effects of MD-7246 on irritable bowel syndrome with diarrhoea. Aliment Pharmacol Ther. 2023 Jan;57(2):192-204. doi: 10.1111/apt.17274. Epub 2022 Nov 2.
• Johnston JM, Kurtz CB, Macdougall JE, Lavins BJ, Currie MG, Fitch DA, O'Dea C, Baird M, Lembo AJ. Linaclotide improves abdominal pain and bowel habits in a phase IIb study of patients with irritable bowel syndrome with constipation. Gastroenterology. 2010 Dec;139(6):1877-1886.e2. doi: 10.1053/j.gastro.2010.08.041. Epub 2010 Aug 27.

Drugs

Indications