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

Pain Clinical Trial

— FAIRTOP II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01270659
• Other study ID #: 1774
• Status: Completed
• Phase: Phase 3
• First received: January 4, 2011
• Last updated: December 2, 2014
• Start date: May 2011
• Est. completion date: October 2014

Study information

• Verified date: December 2014
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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"

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• pain sufficient to warrant medication stronger than acetaminophen (Tylenol) or aspirin

• only if Emergency Department provider approves

• a negative pregnancy test is required for participation for women of childbearing age

Exclusion Criteria:

• If treating provider determines intravenous analgesia is required

• allergy to acetaminophen or any opiate/opioid, or lansoprazole patients currently taking phenothiazines, CNS depressants (including alcohol), or if they have taken an monoamine oxidase inhibitor (MAOI) or selective serotonin reuptake inhibitor (SSRI) in the past two weeks

• if patient has already been administered an opioid analgesic for their current injury

• patients on chronic opioids therapy or a history of opioid abuse

• breastfeeding mothers

• patients who plan to drive home after their emergency department visit

• history of phenylketonuria (due to phenylalanine in the formulation of the lansoprazole solutab)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Fentanyl
Fentanyl buccal tablet 100 mcg once
• Fentanyl
Fentanyl buccal tablet 200 mcg once
• Oxycodone/acetaminophen
Oxycodone/acetaminophen 5/325 mg once
• oxycodone/acetaminophen
Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time

Locations

Country	Name	City	State
United States	Hillcrest Medical Center Emergency Department	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Level	The study's primary endpoint will be the time at which subjects' pain levels dropped significantly (1.3 units) from the initial pain level, using a verbally administered 10 point pain scale.	every 5 minutes for 60 minutes	No
Secondary	Nausea level	Subjects nausea level will be recorded to determine how fentanyl buccal tablet compares to standard therapy in causing nausea	every 5 minutes for the first 60 minutes	No
Secondary	Occurrence of adverse events		the full 2 hours of the study	Yes