In one 12-week randomized, double-blind, placebo-controlled flexible-dosing trial of ULTRAM ER in patients with osteoarthritis of the knee, patients titrated to an average daily ULTRAM ER dose of approximately 270 mg/day. Forty-nine percent of patients randomized to ULTRAM ER completed the study, while 52% of patients randomized to placebo completed the study. Most of the early discontinuations in the ULTRAM ER treatment group were due to adverse events, accounting for 27% of the early discontinuations in contrast to 7% of the discontinuations from the placebo group. Thirty-four percent of the placebo-treated patients discontinued the study due to lack of efficacy compared to 15% of ULTRAM ER-treated patients. The ULTRAM ER group demonstrated a statistically significant decrease in the mean VAS score, and a statistically significant difference in the responder rate, based on the percent change from baseline in the VAS score, measured at 1, 2, 4, 8, and 12 weeks, between patients receiving ULTRAM ER and placebo (see Figure 4).

Figure 4

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