drugset / Trial / NCT00538863

Long-term Safety and Efficacy Study of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain

NCT00538863

Phase 3 Completed 319 enrolled INSYS Therapeutics Inc
Non-randomizedSingle-groupOpen-labelSupportive care

Summary

The purpose of this study was to assess the 90-day safety of fentanyl sublingual spray for the treatment of breakthrough cancer pain in subjects on around-the-clock opioids for their persistent cancer pain.

Timeline

Start
2007-12
Primary completion
2010-10
Completion
2010-10

Drugs

EvaluationDrugModalityDoseRoute
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

Indications