NCT00362583

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

A Double-blind, Randomised, Placebo-controlled Trial Confirming the Efficacy of Intranasal Fentanyl Titrated to 50, 100 or 200 µg With an Open Long-term Safety Follow-up in Cancer Patients With Breakthrough Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Nycomed · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Fentanyl

Timeline

• Start date: 2006-06-01
• Primary completion: 2007-10-01
• Completion: 2008-03-01
• First posted: 2006-08-10
• Last updated: 2012-05-07

Locations

1 site across 1 country: Denmark