drugset / Trial / NCT00216684

Phase III Clinical Trial of Fentanyl Transdermal Matrix Patch, in the Management of Chronic Intractable Pain- Assessment of Effectiveness, Safety and Pharmacokinetics

NCT00216684

Phase 3 Completed 139 enrolled Janssen Pharmaceutical K.K.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to verify the effectiveness, and safety in Japanese patients with chronic intractable pain after 4-week medication of fentanyl transdermal matrix patches containing either 12.5 mcg/hr, 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, or 100 mcg/hr, who have been switched from existing formulations, such as codeine, morphine hydrochloride, or fentanyl injectable. Furthermore, the safety and effectiveness of long term treatment such as 48 weeks are to be assessed, if possible.

Timeline

Start
2005-05
Primary completion
Completion
2006-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Fentanyl Other / unclassified 12.5 ug Other
Subject Fentanyl Other / unclassified 25 ug Other
Subject Fentanyl Other / unclassified 50 ug Other
Subject Fentanyl Other / unclassified 75 ug Other
Subject Fentanyl Other / unclassified 100 ug Other

Indications