European Journal of PainVolume 11, Issue S1 p. S81-S81 186 MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY AND EFFICACY OF LENALIDOMIDE IN THE TREATMENT OF CHRONIC PAINFUL RADICULOPATHY D. Levinsky, D. Levinsky Genova Clinical Research, Tucson, AZ, USASearch for more papers by this authorS. Gupta, S. Gupta Dayton Outpatient Center, Research Institute of Greater Dayton, OH, USASearch for more papers by this authorM. Byas-Smith, M. Byas-Smith Emory University Hospital, Atlanta, GA, USASearch for more papers by this authorM. Hale, M. Hale Gold Coast Research, LLC, Weston, FL, USASearch for more papers by this authorJ. Gimble, J. Gimble Arizona Research Center, Phoenix, AZ, USASearch for more papers by this authorA. Cooper, A. Cooper Celgene Corporation, Summit, NJ, USASearch for more papers by this authorE. Kurkimilis, E. Kurkimilis Celgene Corporation, Summit, NJ, USASearch for more papers by this authorJ. Zeldis, J. Zeldis Celgene Corporation, Summit, NJ, USASearch for more papers by this authorD. Manning, D. Manning Celgene Corporation, Summit, NJ, USASearch for more papers by this author D. Levinsky, D. Levinsky Genova Clinical Research, Tucson, AZ, USASearch for more papers by this authorS. Gupta, S. Gupta Dayton Outpatient Center, Research Institute of Greater Dayton, OH, USASearch for more papers by this authorM. Byas-Smith, M. Byas-Smith Emory University Hospital, Atlanta, GA, USASearch for more papers by this authorM. Hale, M. Hale Gold Coast Research, LLC, Weston, FL, USASearch for more papers by this authorJ. Gimble, J. Gimble Arizona Research Center, Phoenix, AZ, USASearch for more papers by this authorA. Cooper, A. Cooper Celgene Corporation, Summit, NJ, USASearch for more papers by this authorE. Kurkimilis, E. Kurkimilis Celgene Corporation, Summit, NJ, USASearch for more papers by this authorJ. Zeldis, J. Zeldis Celgene Corporation, Summit, NJ, USASearch for more papers by this authorD. Manning, D. Manning Celgene Corporation, Summit, NJ, USASearch for more papers by this author First published: 16 January 2012 https://doi.org/10.1016/j.ejpain.2007.03.201Citations: 1Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat No abstract is available for this article.Citing Literature Volume11, IssueS1June 2007Pages S81-S81 RelatedInformation

Published studies report chronic low-back pain (CLBP) prevalence in the U.S. to be 4-14%. Beyond pain control, assessing disability levels and sleep quality are important aspects of managing patients with CLBP. A phase-3 withdrawal study assessing 12-hour extended-release hydrocodone/acetaminophen (HC/APAP CR) treatment in subjects with CLBP, consisted of the following phases: 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 and study design details are reported elsewhere. Disability level and pain-related sleep interference were assessed and are reported here. To assess disability levels, subjects were given the Roland-Morris Disability Questionnaire (RMDQ), a 24-item self-administered questionnaire, at OL and DB baselines and final visit. Sleep interference was examined at these time points, with additional assessments at weeks 2, 6, and 12. During the OL period, improvements in randomized subjects' disability were demonstrated by reductions in RMDQ scores (mean percent change: –52%) from OL-baseline to DB-baseline. Additionally, mean reduction in subject's assessment of pain-related sleep interference score from OL-baseline to end of the OL-period was 4.0 for all subjects randomized into the DB period. During the DB period, both HC/APAP CR groups demonstrated statistically significantly lower mean percent-change increase in RMDQ scores than the placebo group, from DB-baseline to final visit. More specifically, mean percent increase for RMDQ scores in the 1-tablet HC/APAP CR group was 112% compared to 244% in the placebo group (p<0.001). Similarly, statistically significantly lower mean increase in sleep interference was observed for the HC/APAP CR groups compared with the placebo group at week 2 (p<0.001), week 6 (p<0.001) and week 12 (p<0.003). Twice daily administration of both 1 and 2 tablets of HC/APAP CR improved disability scores and decreased pain-related sleep interference relative to placebo. Funded by Abbott Laboratories.

Analgesic efficacy and safety of hydrocodone/acetaminophen extended-release (HC/APAP CR) was assessed in subjects with moderate-to-severe chronic low-back pain (CLBP). Subjects with CLBP (n=773) were enrolled at 62 sites; study protocol and informed consent were IRB-approved. Study periods were: Washout/Screening, 3-week Active-Drug Open-Label, 12-week Double-Blind in which subjects were randomized to placebo, 1 or 2 tablets HC/APAP CR twice daily, and Taper/Follow-up. Primary efficacy endpoint was mean change from double-blind baseline to final evaluation in Subject's Assessment of CLBP Intensity (VAS). Safety was evaluated by adverse-event (AE) assessment. All results reported are from the Double-Blind period. 511 subjects were randomized and received °Ý1 dose of study drug; data for 507 were evaluated for efficacy. Most subjects were women (59%) and white (87%); mean age 48 years. Baseline variables were similar among the 3 groups. Mean change from baseline CLBP intensity was statistically significantly lower in subjects in the HC/APAP CR groups than in the placebo group (8.6, 2-tablet; 13.3, 1-tablet vs 22.2, placebo; p<0.05); no statistically significant difference was observed between HC/APAP CR groups. The superiority of treatment with both HC/APAP treatments compared to placebo treatment was consistent across multiple secondary efficacy endpoints. 89/169 (53%) subjects in the HC/APAP CR 2-tablet, 75/170 (44%) in the 1-tablet, and 79/172 (46%) in the placebo group reported °Ý1 AE. AEs in °Ý5% of subjects in any treatment group were nausea, constipation, diarrhea, and headache. Nine subjects reported serious AEs (2 in each HC/APAP CR group; 5 in placebo group); 28 subjects discontinued due to AEs (3% in placebo; 6% in 1-tablet; 7% in 2-tablet group). Both HC/APAP CR doses given twice daily were effective treatment for CLBP over the 12-week period. The safety profile of HC/APAP CR was consistent with known profiles of mu-opioid receptor agonists. Funded by Abbott Laboratories. Analgesic efficacy and safety of hydrocodone/acetaminophen extended-release (HC/APAP CR) was assessed in subjects with moderate-to-severe chronic low-back pain (CLBP). Subjects with CLBP (n=773) were enrolled at 62 sites; study protocol and informed consent were IRB-approved. Study periods were: Washout/Screening, 3-week Active-Drug Open-Label, 12-week Double-Blind in which subjects were randomized to placebo, 1 or 2 tablets HC/APAP CR twice daily, and Taper/Follow-up. Primary efficacy endpoint was mean change from double-blind baseline to final evaluation in Subject's Assessment of CLBP Intensity (VAS). Safety was evaluated by adverse-event (AE) assessment. All results reported are from the Double-Blind period. 511 subjects were randomized and received °Ý1 dose of study drug; data for 507 were evaluated for efficacy. Most subjects were women (59%) and white (87%); mean age 48 years. Baseline variables were similar among the 3 groups. Mean change from baseline CLBP intensity was statistically significantly lower in subjects in the HC/APAP CR groups than in the placebo group (8.6, 2-tablet; 13.3, 1-tablet vs 22.2, placebo; p<0.05); no statistically significant difference was observed between HC/APAP CR groups. The superiority of treatment with both HC/APAP treatments compared to placebo treatment was consistent across multiple secondary efficacy endpoints. 89/169 (53%) subjects in the HC/APAP CR 2-tablet, 75/170 (44%) in the 1-tablet, and 79/172 (46%) in the placebo group reported °Ý1 AE. AEs in °Ý5% of subjects in any treatment group were nausea, constipation, diarrhea, and headache. Nine subjects reported serious AEs (2 in each HC/APAP CR group; 5 in placebo group); 28 subjects discontinued due to AEs (3% in placebo; 6% in 1-tablet; 7% in 2-tablet group). Both HC/APAP CR doses given twice daily were effective treatment for CLBP over the 12-week period. The safety profile of HC/APAP CR was consistent with known profiles of mu-opioid receptor agonists. Funded by Abbott Laboratories.

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. 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.