drugset / Trial / NCT00589823

Efficacy and Safety Study of Nasalfent for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioids

NCT00589823

Phase 3 Completed 135 enrolled Archimedes Development Ltd
RandomizedCrossoverQuadruple-blindSupportive care

Summary

Cancer patients taking regular medication for their pain often still have episodes of severe pain that 'break through' despite their background pain treatment. Fentanyl is a strong, short-acting painkiller often used to treat this 'breakthrough' pain. Nasalfent contains fentanyl in a patented drug delivery system called PecSys and is given via a simple nasal spray. This study will test the efficacy and safety of Nasalfent compared to Immediate Release Morphine Sulphate in the treatment of breakthrough cancer pain.

Timeline

Start
2007-06
Primary completion
2009-03
Completion
2009-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fentanyl Other / unclassified 100 ug Intranasal
Comparator Fentanyl Other / unclassified 200 ug Intranasal
Comparator Fentanyl Other / unclassified 400 ug Intranasal
Comparator Fentanyl Other / unclassified 800 ug Intranasal
Subject Immediate release morphine sulphate Unknown Oral

Indications