A Clinical Trial With Intranasal Fentanyl in Cancer Patients With Breakthrough Pain

Summary

The aim of this clinical trial was to demonstrate the efficacy of a 400 μg dose strength of intranasal fentanyl spray (INFS, Instanyl®) and to evaluate the safety and to establish long term tolerability of treatment with INFS doses of 50, 100, 200 and 400 μg.

Timeline

Start

2011-08

Primary completion

2013-01

Completion

2013-01

Outcome

Met primary endpoint

registry Intranasal Fentanyl Spray (INFS) vs Placebo; p = 0.002; LS Mean Difference 1.1 (95% CI 0.41 to 1.179) NCT01429051 ↗

Publications

• Thronaes M, Popper L, Eeg M, Jaatun E, Kvitberg M, Kaasa S. Efficacy and tolerability of intranasal fentanyl spray in cancer patients with breakthrough pain. Clin Ther. 2015 Mar 1;37(3):585-96. doi: 10.1016/j.clinthera.2014.12.010. Epub 2015 Jan 30.

Drugs

Indications