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Table 3 Change in patient-reported outcomes – overall study period

From: Patient-reported health-related quality of life, work productivity, and activity impairment during treatment with ALO-02 (extended-release oxycodone and sequestered naltrexone) for moderate-to-severe chronic low back pain

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
  1. ALO-02 extended-release oxycodone and sequestered naltrexone, LS least squares
  2. 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