• Theophilus J Gana, Maria Luz G Pascual, Rosa Rosanna B Fleming, Jeff R Schein, Carmela C Janagap, Jim Xiang, Gary J Vorsanger, and 023 Study Group.
• Biopharmatech Consulting, Inc., Leesburg, VA, USA.
• Curr Med Res Opin. 2006 Jul 1;22(7):1391-401.

ObjectiveThis study evaluated the efficacy and safety of tramadol extended-release (tramadol ER) tablets once daily in subjects with osteoarthritis pain.MethodsThis 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial included 1020 adults with osteoarthritis of the knee or hip and baseline pain intensity >or= 40 on a 100-mm pain visual analog scale (0 = no pain, 100 = extreme pain). Subjects took placebo or were titrated to a target dose of tramadol ER 100, 200, 300, or 400 mg once daily.Main Outcome MeasuresThe co-primary efficacy variables were pain and physical function subscales of the WOMAC Osteoarthritis Index and subject global assessment of disease activity.ResultsMean changes in WOMAC Osteoarthritis Index pain and physical function subscales were significantly different between tramadol ER and placebo, overall (p ConclusionsTramadol ER 100-300 mg once daily was associated with significant improvement in pain intensity and physical function, and was well tolerated, despite the use of a fixed-dose study design not reflective of usual clinical practice. Tramadol ER is a useful treatment option for patients with osteoarthritis pain.

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