NCT01270659

Safety and Efficacy Study of Fentanyl Buccal Tablet Use in the Emergency Department for Isolated Extremity Injury

Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain: The FAIRTOP II Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate fentanyl buccal tablet (FBT) for analgesia in comparison to standard analgesia, to determine if the FBT allows for faster achievement of "significant analgesia"

Detailed description

The subjects/patients will be asked if they would desire a low dose or high dose pain medication regimen. The low dose (low-FBT) group will receive FBT at a dose of 100 mcg, as well as an oral (pill) placebo preparation. The low dose (low-control) group will receive an "inactive comparator" (lansoprazole rapidly-dissolving buccal 15mg, " FBT placebo") and a dose of 5/325 Percocet tablet (oxycodone/acetaminophen 5/325). The high dose (high-FBT) group will receive 200 mcg FBT plus 2 placebo tablets. The high dose (high-control) group will receive the "FBT placebo" and a dose of 2, 5/325 Percocet tablets.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Fentanyl	Fentanyl buccal tablet 100 mcg once
DRUG	Fentanyl	Fentanyl buccal tablet 200 mcg once
DRUG	Oxycodone/acetaminophen	Oxycodone/acetaminophen 5/325 mg once
DRUG	oxycodone/acetaminophen	Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2011-01-05
• Last updated: 2017-06-20
• Results posted: 2017-06-20

Locations

1 site across 1 country: United States