Table 1.
Baseline demographics and patient characteristics
| Characteristic |
Tapentadol prolonged |
Oxycodone controlled |
|---|---|---|
| release (n = 978) | release (n = 999) | |
| Mean ± SD age, years |
56.8 ± 12.22 |
56.7 ± 12.39 |
| Age category, n (%): |
|
|
| <65 years |
719 (73.5) |
731 (73.2) |
| ≥65 years |
259 (26.5) |
268 (26.8) |
| Gender, n (%) |
|
|
| Female |
639 (65.3) |
601 (60.2%) |
| Male |
339 (34.7) |
398 (39.8) |
| Race, n (%) |
|
|
| White |
803 (82.1) |
813 (81.4) |
| Black |
111 (11.3) |
101 (10.1) |
| Hispanic |
40 (4.1) |
58 (5.8) |
| Other |
24 (2.5) |
27 (2.7) |
| Pain condition, n (%) |
|
|
| Osteoarthritis knee pain |
663 (67.8) |
673 (67.4) |
| Low back pain |
315 (32.2) |
326 (32.6) |
| Mean ± SD pain intensity score *+ |
7.4 ± 1.26 |
7.3 ± 1.21 |
| Pain intensity category, n (%) + ~ |
|
|
| Mild |
2 (0.2) |
0 |
| Moderate |
119 (12.2) |
123 (12.3) |
| Severe |
854 (87.6) |
873 (87.7) |
| Prior opioid experience, n (%) |
|
|
| No |
641 (65.5) |
681 (68.2) |
| Yes | 337 (34.5) | 318 (31.8) |
*Average pain score (11 point numerical rating scale) recorded over the last 72 hours prior to randomisation.
+ Tapentadol n = 975, oxycodone n = 996.
~ Mild pain intensity defined as 1 to <4 on the numerical rating scale, moderate >4 to <6 and severe ≥6.