Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain

Summary

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 in comparison to the buprenorphine transdermal system (BTDS) 5 and oxycodone immediate-release in subjects with moderate to severe low back pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen) will be provided to all subjects in addition to study drug.

Timeline

Start

2004-02

Primary completion

2005-09

Completion

2005-09

Outcome

Met primary endpoint

Stopped: “Terminated early due to administrative reasons unrelated to efficacy or safety.”

registry analysis (superiority or other test); Double-blind BTDS 5 vs Double-blind BTDS 20; p <.001; Mean Difference (Final Values) -0.67 (95% CI -0.99 to -0.35) NCT00313014 ↗

paper The primary endpoint, "average pain in the last 24 hours" during double-blind weeks 4, 8, and 12, was significantly lower for patients receiving BTDS 20 PMID 21807566 ↗

Publications

• Results Steiner D, Munera C, Hale M, Ripa S, Landau C. Efficacy and safety of buprenorphine transdermal system (BTDS) for chronic moderate to severe low back pain: a randomized, double-blind study. J Pain. 2011 Nov;12(11):1163-73. doi: 10.1016/j.jpain.2011.06.003. Epub 2011 Jul 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Buprenorphine	Other / unclassified	5 ug	Other
Subject	Buprenorphine	Other / unclassified	20 ug	Other
Subject	Oxycodone	Other / unclassified	40 mg	Oral

Indications

No indication recorded.