Table 2.
Change in patient-reported outcomes – double-blind treatment period
| Instrument | LS Mean Change | |||
|---|---|---|---|---|
| Placebo | ALO-02 | Differencea | p-value | |
| Short Form-36v2 Health Survey | ||||
| Physical Functioning | −2.06 | −1.44 | 0.62 | 0.5181 |
| Role-Physical | −2.56 | −2.59 | −0.03 | 0.9733 |
| Bodily Pain | −5.07 | −2.69 | 2.37 | 0.0100 |
| General Health | −1.55 | −2.10 | −0.55 | 0.4712 |
| Vitality | −1.62 | −2.77 | −1.16 | 0.2898 |
| Social Functioning | −3.17 | −1.69 | 1.48 | 0.1565 |
| Role-Emotional | −2.57 | −3.44 | −0.86 | 0.5220 |
| Mental Health | −2.95 | −2.93 | 0.02 | 0.9865 |
| Physical Component Score | −2.70 | −1.68 | 1.02 | 0.2491 |
| Mental Component Score | −2.29 | −2.98 | −0.69 | 0.5219 |
| EuroQol 5-Dimensions 3-Level | ||||
| Summary Index | −0.061 | −0.029 | 0.032 | 0.0605 |
| Visual Analog Scale | −3.61 | −2.89 | 0.72 | 0.7196 |
| Work Productivity and Activity Impairment Questionnaire: Specific Health Problem | ||||
| Percentage work time missed due to low back pain | 6.49 | 3.72 | −2.77 | 0.4944 |
| Percentage impairment while working due to low back pain | 6.77 | 4.39 | −2.38 | 0.6008 |
| Percentage overall work impairment due to low back pain | 10.85 | 5.71 | −5.14 | 0.3604 |
| Percentage activity impairment due to low back pain | 10.56 | 6.41 | −4.15 | 0.1031 |
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