Fixed-dose combination of enteric-coated naproxen and immediate-release esomeprazole has comparable efficacy to celecoxib for knee osteoarthritis: two randomized trials

Autor: Marc C. Hochberg, Mark Sostek, John G. Fort, Clara Hwang, Ola Svensson
Rok vydání: 2011
Předmět:
Zdroj: Current Medical Research and Opinion. 27:1243-1253
ISSN: 1473-4877
0300-7995
DOI: 10.1185/03007995.2011.580340
Popis: Objective:To demonstrate that a fixed-dose combination of enteric-coated naproxen 500 mg and immediate-release esomeprazole magnesium 20 mg has comparable efficacy to celecoxib for knee osteoarthritis.Research design and methods:Two randomized, double-blind, parallel-group, placebo-controlled, multicenter phase III studies (PN400-307 and PN400-309) enrolled patients aged ≥50 years with symptomatic knee osteoarthritis. Following an osteoarthritis flare, patients received naproxen/esomeprazole magnesium twice daily, celecoxib 200 mg once daily, or placebo for 12 weeks.Clinical trial registration:NCT00664560 and NCT00665431.Main outcome measures:Three co-primary efficacy endpoints were mean change from baseline to week 12 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain and function subscales, and Patient Global Assessment of osteoarthritis using a visual analog scale (PGA-VAS).Results:In Study 307, 619 patients were randomized and 614 treated. In Study 309, 615 patients were randomi...
Databáze: OpenAIRE