A Research Study of MK0633 in Patients With Chronic Obstructive Pulmonary Disease (COPD)(0633-009)(COMPLETED)

Phase 2 Completed 266 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

A clinical study to evaluate the efficacy and safety of MK0633 in patients with Chronic Obstructive Pulmonary Disease (COPD).

Timeline

Start: 2008-01
Primary completion: 2009-03
Completion: 2009-03

Outcome

Missed primary endpoint

paper The 5-LO inhibitor MK-0633 was not significantly more effective than placebo in improving FEV(1) from baseline in patients with COPD PMID 20970976 ↗

paper The change in FEV(1) over the last 2 weeks of the 12 weeks treatment period compared to baseline was 0.015 L for MK-0633 and 0.0002 for placebo (p = 0.556). PMID 20970976 ↗

Publications

Bernstein JA, Liu N, Knorr BA, Smugar SS, Hanley WD, Reiss TF, Greenberg S. MK-0633, a potent 5-lipoxygenase inhibitor, in chronic obstructive pulmonary disease. Respir Med. 2011 Mar;105(3):392-401. doi: 10.1016/j.rmed.2010.09.021. Epub 2010 Nov 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SETILEUTON	Small molecule	100 mg	Oral