Intranasal Fentanyl for the Treatment of Breakthrough Pain in Cancer Patients (FT-017-IM)
To demonstrate the efficacy of intranasal fentanyl in the treatment of breakthrough pain (BTP) in cancer patients.
To explore the relationship between the response to the fentanyl dose and the stable background pain opioid dose.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Intranasal Fentanyl for the Treatment of Breakthrough Pain in Cancer Patients. A Randomised, Double-blind, Placebo-controlled, Cross-over Confirmatory Trial Testing Fentanyl and Placebo in Eight Breakthrough Pain Episodes|
- Pain intensity difference at 10 minutes (PID10) after administration
- Sum of pain intensity differences over the 0-60 minute time interval (SPID0-60) and General Impression (GI) with 5 point verbal rating scale at 60 minutes
|Study Start Date:||May 2006|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|