Efficacy/Safety Study of ACTIQ® for Opioid-Tolerant Children and Adolescents With Breakthrough Pain (BTP)
Status:
Completed
Trial end date:
2006-08-01
Target enrollment:
Participant gender:
Summary
The primary objective of the study is to evaluate the efficacy of ACTIQ treatment for the
management of breakthrough pain (BTP) compared to placebo treatment in children with cancer
and non-cancer pain who are receiving around-the-clock (ATC) opioid therapy and who require
additional therapy for BTP episodes. This will be determined by the analysis of the pain
intensity (PI), measured by the Faces Pain Scale-Revised (FPS-R) administered 15 minutes
after the start of each unit of study drug with an optimal ACTIQ dosage.