NCT00538850

Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain

A Randomized, Double-blind, Placebo-controlled Multi-center Study to Evaluate the Safety and Efficacy of Fentanyl Sublingual Spray (Fentanyl SL Spray) for the Treatment of Breakthrough Cancer Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: INSYS Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain. The study medication is administered under the tongue as a simple spray and can be self-administered by patients or assisted by their caregivers. Patients are titrated to an effective-dose of fentanyl sublingual spray in the open-label titration period and then proceed to the double-blind randomized period where they randomly receive 7 treatments with fentanyl sublingual spray and 3 treatments with placebo. Patients are treated for up to a total of 6-7 weeks (including both the open-label titration and the double-blind randomized periods).

Detailed description

RATIONALE Fentanyl sublingual spray may help relieve breakthrough pain in patients receiving opioids for cancer pain. OBJECTIVES Primary * Determine the efficacy and safety of fentanyl sublingual spray for the treatment of breakthrough cancer pain in patients on around-the-clock opioids for their persistent cancer pain. Secondary * Evaluate the safety of fentanyl sublingual spray in these opioid-tolerant patients. * Assess the patient's satisfaction with treatment medication.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Fentanyl sublingual spray	In the open-label titration period of the study, participants started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 21±5 days was reached. In the double-blind period of the study, participants received fentanyl sublingual spray in doses of 100, 200, 400, 600, 800, 1200, or 1600 µg determined in the open-label titration period of the study.
DRUG	Placebo	Matching placebo to fentanyl sublingual spray.

Timeline

• Start date: 2007-10-01
• Primary completion: 2010-02-01
• Completion: 2010-10-01
• First posted: 2007-10-03
• Last updated: 2014-03-05
• Results posted: 2014-03-05

Locations

1 site across 1 country: United States