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

May 19, 2017 updated by: University of Oklahoma

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

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"

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Hillcrest Medical Center Emergency Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low-FBT
Subject will receive FBT and placebo at a low dose
Drug: Fentanyl
Fentanyl buccal tablet 100 mcg once
Other Names:
  • Fentora 100 mcg buccal tablet
Drug: Fentanyl
Fentanyl buccal tablet 200 mcg once
Other Names:
  • Fentora buccal tablet 200 mcg
Experimental: High-FBT
Subject will receive the high dose regimen of FBT and a high dose placebo
Drug: Fentanyl
Fentanyl buccal tablet 100 mcg once
Other Names:
  • Fentora 100 mcg buccal tablet
Drug: Fentanyl
Fentanyl buccal tablet 200 mcg once
Other Names:
  • Fentora buccal tablet 200 mcg
Active Comparator: Low control
Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo"
Drug: Oxycodone/acetaminophen
Oxycodone/acetaminophen 5/325 mg once
Other Names:
  • Percocet 5/325
Active Comparator: High control
Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl "placebo"
Drug: oxycodone/acetaminophen
Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time
Other Names:
  • Percocet 5/325

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level)
Time Frame: 60 minutes
Median time (in minutes) to 2 units decrease in pain level after drug administration. Patients were asked to rate their pain at every 5 minutes intervals from 0 to 60 minutes post drug administration. The 10-point verbally administered numeric pain rating scale (NPRS) was used to have patients rate their level of pain on a scale of 0 (no pain) to 10 (worst pain ever).
60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nausea Level
Time Frame: every 5 minutes for the first 60 minutes

Subjects' nausea level was recorded to determine how fentanyl buccal tablet compares to standard therapy in causing nausea. Treatment induced nausea and severity of nausea level was assessed.

Nausea was assessed by a 10-point verbally administered scale. Patients rated their degree of nausea on a scale of 0 (no nausea) to 10 (worst nausea).

At the beginning of the study, literature review found relatively little evidence guiding objective means to rate nausea, but there was some precedent for this approach (Warden C. Prehospital use of ondansetron reduces nausea and episodes of vomiting in adults and children over 12 years old [abstract]. Prehosp Emerg Care. 2007;11:132).
every 5 minutes for the first 60 minutes
Number of Participants Experiencing Any Adverse Events
Time Frame: Full 2 hours of the study period
Occurrence of any adverse event.
Full 2 hours of the study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Stephen H Thomas, MD MPH, University of Oklahoma
  • Study Director: Annette O Arthur, PharmD, University of Oklahoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

January 4, 2011

First Submitted That Met QC Criteria

January 4, 2011

First Posted (Estimate)

January 5, 2011

Study Record Updates

Last Update Posted (Actual)

June 20, 2017

Last Update Submitted That Met QC Criteria

May 19, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1774

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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