A randomized, placebo-controlled, double-blinded, parallel-group, 5-week study of buprenorphine transdermal system in adults with osteoarthritis

Journal of Opioid Management
Catherine MuneraCraig Landau

Abstract

This multicenter, parallel-group, 35-day study in adults with osteoarthritis (OA) pain evaluated the analgesic efficacy and safety of buprenorphine transdermal system (BTDS) designed for 7-day wear. Patients with OA pain inadequately controlled with nonsteroidal antiinflammatory drugs or patients who had taken opioids for OA pain within the past year entered a 7-day run-in period during which they took ibuprofen only. Patients with pain > or = on a 0-10 scale had their ibuprofen discontinued and were randomized into a 28-day double-blinded period to receive either BTDS at 1 of 3 dose levels (5, 10, or 20 microg/b) or placebo. Doses were titrated to effectiveness over a period of 21 days and maintained for 7 days. No rescue medication was allowed during the study. The primary efficacy measure was the proportion of patients who achieved treatment success, defined as a patient satisfaction score of good, very good, or excellent (on day 28 or at early discontinuation) for those who did not discontinue due to ineffective treatment. More BTDS-treated patients experienced treatment success than placebo TDS-treated patients (44 percent and 32 percent; odds ratio = 1.66, p = 0.036). Fewer patients taking BTDS titrated to the highest dos...Continue Reading

Citations

Mar 1, 2012·CNS Drugs·Greg L Plosker, Katherine A Lyseng-Williamson
Sep 13, 2011·Current Medical Research and Opinion·Rob RiemsmaSteffen Stürzebecher
Oct 3, 2012·Journal of Pain and Symptom Management·Ram P KapilStephen C Harris
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Aug 3, 2011·The Journal of Pain : Official Journal of the American Pain Society·Deborah SteinerCraig Landau
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Jun 28, 2021·Journal of Controlled Release : Official Journal of the Controlled Release Society·Garima SharmaJin-Chul Kim

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