Francis Burch, Ritchard Fishman, Nicholas Messina, Bruce Corser, Florin Radulescu, Adrian Sarbu, Marcela M. Craciun-Nicodin, Rodica Chiriac, AndrÃ© Beaulieu, Jude Rodrigues et al.
One thousand twenty-eight (1,028) patients with pain due to osteoarthritis (OA) of the knee were enrolled in this multicenter, randomized, double-blind, parallel study designed to assess the analgesic efficacy and safety of Tramadol ContramidÂ® OAD compared to placebo. Patients were titrated to their optimal dose (200 mg or 300 mg), which was maintained for 12 weeks. An absolute mean reduction of 3.0 Â± 2.1 on a Pain Intensity Numerical Rating Scale (PI-NRS) was noted in the Tramadol Contramid OAD treatment group. The difference between active and placebo groups regarding this absolute mean reduction was statistically significant throughout the study. The responder analysis demonstrated that a significantly greater percentage of patients in the active treatment arm achieved a reduction of ?1 and ?2 points on the PI-NRS score by the end of the study. A significantly greater percentage of respondents in the Tramadol Contramid OAD group indicated improvement on both the Patient and Physician Global Impressions of Change. Both the 200 mg and 300 mg doses contributed to the overall superiority of Tramadol Contramid OAD. The most frequent adverse events were consistent with the known side effects of tramadol and were generally mild to moderate in intensity. These results confirm that Tramadol Contramid OAD given once daily is an efficacious and safe treatment for pain due to OA.
Journal of Pain and Symptom Management, 2007, 34(3),