(256) Subject’s and physician’s global assessment of chronic low-back pain status after treatment with 12-hour extended-release hydrocodone/acetaminophen tablets: A 3-week open-label, 12-week randomized double-blinded placebo-controlled withdrawal trial

Chronic pain patients and the physicians who treat them may have differing assessments of pain and the affect of treatment on their pain. The use of the Subject’s Global Assessment (SGA) and Physician’s Global Assessment (PGA) in clinical trials allows patients and physicians to assess pain with a standardized questionnaire during treatment. A phase-3 withdrawal study assessing 12-hour extended-release hydrocodone/ acetaminophen (HC/APAP CR) treatment in chronic low-back pain (CLBP) consisted of the following periods: Washout/Screening, 3-week Active-Drug Open-Label (OL), 12-week Double-Blind (DB), in which subjects were randomized to placebo, 1 or 2 tablets HC/APAP CR twice daily, and Taper/Follow-up. Primary endpoint results and study design details are reported elsewhere. Subject’s (SGA) and physician’s (PGA) global assessment of Back Pain Status are reported here. Subjects’ assessment of their Back Pain Status was evaluated using a 5-point categorical scale (ranges: very good to very poor). Physician’s assessment of subject’s back pain was evaluated based on a 5-point categorical scale (ranges: very mild to very severe). Both measures were evaluated at the OL-baseline, DB-baseline, week-2, week-6, and week-12 visits. At weeks 2, 6 and 12, statistically significantly greater proportions of subjects in the HC/APAP CR 2-tablet group assessed their CLBP favorably on the SGA compared with subjects in the placebo group. Additionally, statistically significantly greater proportions of subjects in the HC/APAP CR 1-tablet group assessed their CLBP favorably, at weeks 6 and 12, on the SGA compared with subjects in the placebo group. Similarly the distribution of PGA scores at weeks 2, 6, and 12, was statistically significantly superior for each HC/APAP CR treatment group compared to the placebo treatment group. Global assessments of CLBP status, as rated by both subjects and physicians, were more favorable in the both HC/APAP CR groups compared with the placebo group. Funded by Abbott Laboratories.