Efficacy and Safety of the Seven-Day Buprenorphine Transdermal System in Opioid-Naïve Patients with Moderate to Severe Chronic Low Back Pain: An Enriched, Randomized, Double-Blind, Placebo-Controlled Study

摘要: Context. This article presents the results of a pivotal Phase 3 study that assesses new treatment for management chronic low back pain: transdermal patch containing opioid buprenorphine. In this randomized, placebo- controlled with an enriched enrollment design, buprenorphine system (BTDS) was found to be efficacious and generally well tolerated. Objectives. enriched, multicenter, double-blind evaluated efficacy, tolerability, safety BTDS in opioid-na€ive patients who had moderate severe pain. Methods. Patients tolerated responded (10 or 20 mcg/hour) during open-label run-in period were randomized continue 10 mcg/hour receive matching placebo. The primary outcome ''average pain over last 24 hours'' at end 12-week phase, collected on 11-point scale (0 ¼ no pain, as bad you can imagine). Sleep disturbance (Medical Outcomes Study subscale) total number supplemental analgesic tablets used secondary efficacy variables. Results. Fifty-three percent receiving (541 1024) (n 257) placebo 284). reported statistically significantly lower scores Week 12 comparedwithplacebo(leastsquaremeantreatmentdifference: � 0.58,P 0.010). Sensitivity analyses variable analysis variables supported relative During incidence treatment-emergent adverse