drugset / Trial / NCT00362583

Efficacy and Safety of Intranasal Fentanyl in the Treatment of Breakthrough Pain (FT-018-IM)

NCT00362583

Phase 3 Completed 100 enrolled Nycomed
RandomizedSingle-groupDouble-blindTreatment

Summary

Primary objectives: * To confirm the efficacy of intranasal fentanyl titrated to doses 50, 100 or 200 µg for treatment of breakthrough pain (BTP) in cancer patients * To establish long-term safety of treatment with intranasal fentanyl Secondary objectives: \- To explore the relationship between dose of background opioid treatment and titrated fentanyl dose

Timeline

Start
2006-06
Primary completion
2007-10
Completion
2008-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Fentanyl Other / unclassified 50 ug Intranasal
Subject Fentanyl Other / unclassified 100 ug Intranasal
Subject Fentanyl Other / unclassified 200 ug Intranasal

Indications