@article {Smugar:July 2006:0300-7995:1353,
	author = "Smugar, Steven S.",
	author = "Schnitzer, Thomas J.",
	author = "Weaver, Arthur L.",
	author = "Rubin, Bernard R.",
	author = "Polis, Adam B.",
	author = "Tershakovec, Andrew M.",
	title = "Rofecoxib 12.5 mg, rofecoxib 25 mg, and celecoxib 200 mg in the treatment of symptomatic osteoarthritis: results of two similarly designed studies",
	journal = "Current Medical Research and Opinion",
	volume = "22",
	year = "July 2006",
	abstract = "<I>Objective:</I> To compare the efficacy of rofecoxib and celecoxib for the treatment of knee or hip OA over 6 weeks.<P></P><I>Methods:</I> Two similarly designed, multicenter, randomized, double-blind, placebo-controlled studies. Patients were randomly assigned 3:3:3:1 in Study 1 to once daily (QD) rofecoxib 12.5 mg (<I>N</I> = 456), rofecoxib 25 mg (<I>N</I> = 459), celecoxib 200 mg (<I>N</I> = 456), or placebo (<I>N</I> = 150) and 3:3:1 in Study 2 to QD rofecoxib 25 mg (<I>N</I> = 471), celecoxib 200 mg (<I>N</I> = 460), or placebo (<I>N</I> = 151). There was no rofecoxib 12.5 mg arm in Study 2. The primary outcome measure of both studies was pain at night over 6 weeks for rofecoxib 25 mg vs. celecoxib 200 mg. Efficacy comparisons with rofecoxib 12.5 mg in Study 1 were included as pre-specified study objectives but not as pre-specified study hypotheses. Secondary endpoints included Patient Global Assessment of Response to Therapy (PGART) over 6 weeks and over 1 week. Safety was evaluated through the assessment of spontaneously reported adverse experiences (AEs), evaluation of vital signs, and laboratory data reported by investigators and patients.<P></P><I>Results:</I> For the primary endpoint, reduction in pain at night over 6 weeks in Study 1 was not significantly different between active treatments; in Study 2 rofecoxib 25 mg significantly (<I>p</I> = 0.023) reduced pain at night compared with celecoxib 200 mg over 6 weeks. For the secondary endpoints, in both studies, significantly (<I>p</I> &#60; 0.05) more patients treated with rofecoxib 25 mg than celecoxib 200 mg had a good or excellent PGART over 6 weeks, and over the first week (<I>p</I> &#60; 0.01). In both studies, there were no significant differences between active medications in the incidence of reported overall, serious, or drug-related AEs. The reported AE rates with the active treatments were generally similar to those with placebo in the two studies.<P></P><I>Conclusions:</I> Rofecoxib 25 mg was significantly better than celecoxib 200 mg in relieving night pain at 6 weeks in one study; this was not confirmed in the accompanying study.",
	pages = "1353-1367(15)",
	url = "http://www.ingentaconnect.com/content/apl/cmro/2006/00000022/00000007/art00013"
	doi = "doi:10.1185/030079906X104876"
}