Table 3.
Change in patient-reported outcomes – overall study period
| Instrument | LS Mean Change | |||
|---|---|---|---|---|
| Placebo | ALO-02 | Differencea | p-value | |
| Short Form-36v2 Health Survey | ||||
| Physical Functioning | 5.32 | 6.84 | 1.52 | 0.1731 |
| Role-Physical | 5.68 | 6.78 | 1.10 | 0.3290 |
| Bodily Pain | 6.39 | 8.78 | 2.39 | 0.0232 |
| General Health | 1.28 | 1.07 | −0.20 | 0.8139 |
| Vitality | 3.46 | 3.01 | −0.45 | 0.6878 |
| Social Functioning | 3.58 | 5.57 | 2.00 | 0.0658 |
| Role-Emotional | 0.99 | 1.22 | 0.23 | 0.8670 |
| Mental Health | 0.09 | 0.47 | 0.37 | 0.7259 |
| Physical Component Score | 6.42 | 8.09 | 1.67 | 0.0989 |
| Mental Component Score | −0.44 | −0.45 | 0.00 | 0.9969 |
| EuroQol 5-Dimensions-3 Level | ||||
| Summary Index | 0.085 | 0.106 | 0.021 | 0.2280 |
| Visual Analog Scale | 4.75 | 7.01 | 2.26 | 0.2701 |
| Work Productivity and Activity Impairment Questionnaire: Specific Health Problem | ||||
| Percentage work time missed due to low back pain | −1.00 | −2.09 | −1.09 | 0.7480 |
| Percentage impairment while working due to low back pain | −16.18 | −25.38 | −9.20 | 0.0581 |
| Percentage overall work impairment due to low back pain | −15.16 | −25.51 | −10.35 | 0.0679 |
| Percentage activity impairment due to low back pain | −18.62 | −26.81 | −8.19 | 0.0040 |
ALO-02 extended-release oxycodone and sequestered naltrexone, LS least squares
aDifference calculated as ALO-02 minus placebo; a positive difference favors ALO-02 and a negative difference favors placebo for SF-36v2 and EQ-5D-3L; a negative difference favors ALO-02 for WPAI:SHP