Original ArticleTreatment of Osteoarthritis With Celecoxib, a Cyclooxygenase-2 Inhibitor: A Randomized Controlled Trial
Section snippets
Study Population
Male and female outpatients aged 18 years or older were eligible to participate if they fulfilled the American College of Rheumatology clinical criteria for a diagnosis of primary OA of the knee and were in a functional class of I, II, or III.20, 21 Patients were required to have symptomatic OA as evidenced by a defined worsening of the signs and symptoms of the disease following discontinuation of treatment with NSAIDs or other analgesic medications or to have met other criteria if the patient
Patient Characteristics
A total of 1003 patients were enrolled in the trial. No significant differences between the 5 treatment groups were detected with respect to demographic characteristics or measures of OA disease activity at baseline (Table 1). More than 70% of the patients evaluated their condition as poor or very poor in the patient's and physician's global assessments following withdrawal from an NSAID and other analgesic therapy. The study was completed by 569 (57%) patients. Reasons for early
Discussion
The results of this large, randomized, double-blind, placebo-controlled trial show the clinical efficacy of celecoxib, an anti-inflammatory/analgesic agent that primarily inhibits COX-2 and does not inhibit COX-1 at therapeutic doses, in patients with OA of the knee. Treatment with celecoxib for a period of 12 weeks was associated in a dose-related fashion with a reduction in the signs and symptoms of OA as shown by several measures of efficacy. The magnitude of improvement observed with
Acknowledgments
The following investigators participated in this trial: John L. Baldwin, MD, Bellevue, Wash; Herbert S. B. Baraf, MD, Wheaton, Md; Scott W. Baumgartner, MD, Spokane, Wash; Anthony Bohan, MD, JD, MHA, Newport Beach, Calif; Milan L. Brandon, MD, San Diego, Calif; Francis X. Burch, MD, San Antonio, Tex; Michael C. Burnette, MD, Tampa, Fla; Barbara A. Caciolo, MD, St Louis, Mo; Jacques R. Caldwell, MD, Gainesville, Fla; Stanley B. Cohen, MD, Dallas, Tex; Selwyn A. Cohen, MD, Trumbull, Conn; Francis
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Presented as a poster at the American College of Rheumatology annual meeting, San Diego, Calif, November 10,1998.
This study was supported in part by G. D. Searle & Co.