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Efficacy and Safety of Tramadol/Acetaminophen Tablets (Ultracet®) as Add-on Therapy for Osteoarthritis Pain in Subjects Receiving a COX-2 Nonsteroidal Antiinflammatory Drug: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
RONALD EMKEY, NORMAN ROSENTHAL, SHU-CHEN WU, DONNA JORDAN, and MARC KAMIN, for the CAPSS-114 Study Group
ABSTRACT.
Methods. This 91-day, multicenter, randomized, double-blind, placebo-controlled trial enrolled subjects with symptomatic OA for ³ 1 year who experienced at least moderate pain [visual analog scale (VAS) score ³ 50/100 mm] despite treatment with stable doses of celecoxib (³ 200 mg/day) or rofecoxib (³ 25 mg/day). Tramadol/APAP or matching placebo was titrated to 4 tablets/day on Day 10 and thereafter as needed up to 8 tablets/day. The primary efficacy measure was final VAS score; secondary measures included final pain relief rating scores, subject/investigator overall medication assessments, rate and time to discontinuation due to lack of efficacy, and selected quality-of-life/physical functioning scores. Results. Of 307 subjects randomized, 306 taking celecoxib (56.5%) or rofecoxib (43.5%) were included in the intent-to-treat population (n = 153 tramadol/APAP, 153 placebo). Mean final VAS scores for tramadol/APAP plus COX-2 NSAID were significantly lower than placebo plus COX-2 NSAID (41.5 vs 48.3; p = 0.025) and mean final pain relief rating scores were significantly higher (p = 0.002). Subjects taking tramadol/APAP showed significant improvements compared with placebo in subject/investigator medication assessments, as well as in the WOMAC Physical Function and the Medical Outcome Study Short Form-36 Role-Physical measures. The most common treatment-related adverse events for tramadol/APAP were somnolence (6.5%), nausea (4.6%), and constipation (3.3%). Mean tramadol/APAP dose was 4.1 tablets (154 mg tramadol/ 1332 mg APAP). Conclusion. Tramadol 37.5 mg/APAP 325 mg combination tablets were effective and safe as add-on therapy with COX-2 NSAID for treatment of OA pain. (J Rheumatol 2004;31:150-6) Key Indexing Terms:
OSTEOARTHRITIS
From the Radiant Research/Reading,Wyomissing, Pennsylvania; and Ortho-McNeil Pharmaceutical, Raritan, New Jersey, USA. Supported by Ortho-McNeil Pharmaceutical, Inc., Raritan, New Jersey, USA. R. Emkey, MD, Radiant Research/Reading; N.R. Rosenthal, MD; S-C. Wu, PhD; D. Jordan, BSN; M. Kamin, MD, Ortho-McNeil Pharmaceutical. Address reprint requests to Dr. R. Emkey, Radiant Research/Reading, 1235 Penn Avenue, Suite 200, Wyomissing, PA 19610. E-mail: ronaldemkey@radiantresearch.com Submitted January 29, 2003; revision accepted June 16, 2003. |