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Table 2 Change in patient-reported outcomes – double-blind treatment 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 −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
  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