drugset / Trial / NCT00362583
Efficacy and Safety of Intranasal Fentanyl in the Treatment of Breakthrough Pain (FT-018-IM)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fentanyl | Other / unclassified | 50 ug | Intranasal |
| Subject | Fentanyl | Other / unclassified | 100 ug | Intranasal |
| Subject | Fentanyl | Other / unclassified | 200 ug | Intranasal |