Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
Status:
Completed
Trial end date:
2010-10-01
Target enrollment:
Participant gender:
Summary
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the
clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.
The study medication is administered under the tongue as a simple spray and can be
self-administered by patients or assisted by their caregivers. Patients are titrated to an
effective-dose of fentanyl sublingual spray in the open-label titration period and then
proceed to the double-blind randomized period where they randomly receive 7 treatments with
fentanyl sublingual spray and 3 treatments with placebo. Patients are treated for up to a
total of 6-7 weeks (including both the open-label titration and the double-blind randomized
periods).