Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
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).
Timeline
- Start
- 2007-10
- Primary completion
- 2010-02
- Completion
- 2010-10
Outcome
Met primary endpoint
paper Relative to placebo, fentanyl sublingual spray significantly improved mean SPID scores PMID 22480131 ↗
paper including the primary endpoint at 30 minutes (p < 0.0001). PMID 22480131 ↗
Publications
- Results Rauck R, Reynolds L, Geach J, Bull J, Stearns L, Scherlis M, Parikh N, Dillaha L. Efficacy and safety of fentanyl sublingual spray for the treatment of breakthrough cancer pain: a randomized, double-blind, placebo-controlled study. Curr Med Res Opin. 2012 May;28(5):859-70. doi: 10.1185/03007995.2012.683111. Epub 2012 May 2.
- Alberts DS, Smith CC, Parikh N, Rauck RL. Fentanyl sublingual spray for breakthrough cancer pain in patients receiving transdermal fentanyl. Pain Manag. 2016 Oct;6(5):427-34. doi: 10.2217/pmt-2015-0009. Epub 2016 Mar 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fentanyl | Other / unclassified | 100 ug | Other |
| Subject | Fentanyl | Other / unclassified | 200 ug | Other |
| Subject | Fentanyl | Other / unclassified | 400 ug | Other |
| Subject | Fentanyl | Other / unclassified | 600 ug | Other |
| Subject | Fentanyl | Other / unclassified | 800 ug | Other |
| Subject | Fentanyl | Other / unclassified | 1200 ug | Other |
| Subject | Fentanyl | Other / unclassified | 1600 ug | Other |