Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation

Phase 3 Completed 590 enrolled Sucampo Pharma Americas, LLC Takeda · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The primary purpose of this study is to evaluate the efficacy and safety of administration of lubiprostone in patients with irritable bowel syndrome with constipation.

Timeline

Start: 2005-05
Primary completion: —
Completion: 2006-07

Outcome

Met primary endpoint

registry analysis (unspecified test); Lubiprostone Study Period I vs Placebo Study Period I; p = 0.029; Cochran-Mantel-Haenszel; note: No adjustment NCT00380250 ↗

paper a significantly higher percentage of lubiprostone-treated patients were considered overall responders compared with those treated with placebo (17.9% vs. 10.1%, P=0.001). PMID 19006537 ↗

Publications

Results Drossman DA, Chey WD, Johanson JF, Fass R, Scott C, Panas R, Ueno R. Clinical trial: lubiprostone in patients with constipation-associated irritable bowel syndrome--results of two randomized, placebo-controlled studies. Aliment Pharmacol Ther. 2009 Feb 1;29(3):329-41. doi: 10.1111/j.1365-2036.2008.03881.x. Epub 2008 Nov 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lubiprostone	Small molecule	8 ug	—