Open-Label Study to Evaluate the Effect of Treatment With Fentanyl Buccal Tablets on Pain Anxiety Symptoms When Used for the Management of Breakthrough Pain

Summary

The primary purpose of the study is to evaluate the impact of treatment with fentanyl buccal tablets on the anxiety symptoms commonly associated with chronic pain in patients with breakthrough pain (BTP). Other purposes are to assess the management of BTP, to evaluate patient functioning, and to determine any influences on the successful dose achieved.

Timeline

Start

2006-12

Primary completion

2007-10

Completion

2007-10

Outcome

Missed primary endpoint

Stopped: “The sponsor felt enough information was available for the exploratory assessment of the effect of treatment with FBT on pain anxiety”

registry p = 0.3223; Mean Difference (Net) -1.6 (95% CI -4.64 to 1.54); t-test, 2 sided NCT00387010 ↗

paper The change from baseline in PASS total score was not statistically significant (mean change, -1.6; p = 0.322). PMID 21957829 ↗

Publications

• Results Webster LR, Messina J, Xie F, Nalamachu S. Effect of fentanyl buccal tablet on pain-related anxiety: a 4-week open-label study among opioid-tolerant patients with chronic and breakthrough pain. J Opioid Manag. 2011 Jul-Aug;7(4):297-308.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fentanyl	Other / unclassified	100 ug	Other
Subject	Fentanyl	Other / unclassified	200 ug	Other
Subject	Fentanyl	Other / unclassified	400 ug	Other
Subject	Fentanyl	Other / unclassified	600 ug	Other
Subject	Fentanyl	Other / unclassified	800 ug	Other

Indications