Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain

Phase 3 Completed 204 enrolled Purdue Pharma LP

RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in subjects with osteoarthritis pain of the hip or knee. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication will be allowed.

Timeline

Start: 2003-06
Primary completion: 2004-07
Completion: 2004-07

Outcome

Met primary endpoint

paper A total of 84.3% of patients met the primary end point, completion of the 14-day double-blind phase (167/198 patients, 95% CI 79.3 - 89.4). PMID 22409388 ↗

Publications

Results Ripa SR, McCarberg BH, Munera C, Wen W, Landau CJ. A randomized, 14-day, double-blind study evaluating conversion from hydrocodone/acetaminophen (Vicodin) to buprenorphine transdermal system 10 mug/h or 20 mug/h in patients with osteoarthritis pain. Expert Opin Pharmacother. 2012 Jun;13(9):1229-41. doi: 10.1517/14656566.2012.667073. Epub 2012 Mar 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Buprenorphine	Other / unclassified	10 ug	Other
Subject	Buprenorphine	Other / unclassified	20 ug	Other