Comparison of Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq) in Cancer Breakthrough Pain (FT-019-IM)

Summary

Primary: • To compare the efficacy of nasal fentanyl (NF) to oral transmucosal fentanyl (Actiq®) (hereafter Actiq) in the management of breakthrough pain in cancer patients. Secondary: * To compare patients' general impression and preference of NF and Actiq * To explore the relationship between NF doses and dose of current opioid for breakthrough pain (BTP) and the relationship between dose of NF and of background opioid * To assess safety and tolerability of NF

Timeline

Start

2007-01

Primary completion

2008-08

Completion

2009-10

Outcome

Met primary endpoint

paper median time to onset of 'meaningful' pain relief was 11 minutes with INFS versus 16 minutes with OTFC PMID 19792837 ↗

paper 65.7% of patients attained faster time to 'meaningful' pain-relief onset with INFS (p < 0.001). PMID 19792837 ↗

Publications

• Mercadante S, Radbruch L, Davies A, Poulain P, Sitte T, Perkins P, Colberg T, Camba MA. A comparison of intranasal fentanyl spray with oral transmucosal fentanyl citrate for the treatment of breakthrough cancer pain: an open-label, randomised, crossover trial. Curr Med Res Opin. 2009 Nov;25(11):2805-15. doi: 10.1185/03007990903336135.

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

Indications

No indication recorded.