NORSPAN Transdermal Patches Phase III Study In Non-Cancer Pain

Summary

This is a multiple-dose, double-blind, double-dummy, active-control, parallel-group, multi-center, safety and efficacy study.

Timeline

Start

2009-08

Primary completion

2010-06

Completion

—

Outcome

Met primary endpoint

paper 0.45 (95% confidence interval, -0.02 to 0.91), which was within the ±1.5 cm predefined threshold PMID 25503600 ↗

paper indicating that the effectiveness of BTDS was not inferior to the effectiveness of sustained-release tramadol tablets. PMID 25503600 ↗

Publications

• Leng X, Li Z, Lv H, Zheng Y, Liu Y, Dai K, Yao C, Yan X, Zeng X. Effectiveness and Safety of Transdermal Buprenorphine Versus Sustained-release Tramadol in Patients With Moderate to Severe Musculoskeletal Pain: An 8-Week, Randomized, Double-Blind, Double-Dummy, Multicenter, Active-controlled, Noninferiority Study. Clin J Pain. 2015 Jul;31(7):612-20. doi: 10.1097/AJP.0000000000000144.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Buprenorphine	Other / unclassified	5 ug	Other
Comparator	Buprenorphine	Other / unclassified	10 ug	Other
Comparator	Buprenorphine	Other / unclassified	20 ug	Other
Subject	Tramadol	Other / unclassified	100 mg	Oral
Subject	Tramadol	Other / unclassified	200 mg	Oral

Indications