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November 21, 2001

Reporting of 6-Month vs 12-Month Data in a Clinical Trial of Celecoxib

Author Affiliations

Stephen J.LurieMD, PhD, Senior EditorIndividualAuthorJody W.ZylkeMD, Contributing EditorIndividualAuthor

JAMA. 2001;286(19):2398-2400. doi:10.1001/jama.286.19.2398

To the Editor: The authors of the CLASS trial1 reported that celecoxib caused fewer symptomatic ulcers and ulcer complications than did diclofenac or ibuprofen at 6 months of follow-up.1 We are concerned that subsequent information from the trial, which is available on the US Food and Drug Administration (FDA) Web site,2 appears to contradict these conclusions. As described on the FDA Web site, the published CLASS trial differs from the original protocol in primary outcomes, statistical analysis, trial duration, and conclusions.24 In particular, the unpublished data show that by week 65, celecoxib was associated with a similar number of ulcer complications as diclofenac and ibuprofen.2

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