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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01270659
Recruitment Status : Completed
First Posted : January 5, 2011
Results First Posted : June 20, 2017
Last Update Posted : June 20, 2017
Information provided by (Responsible Party):
University of Oklahoma

Brief 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"

Condition or disease Intervention/treatment Phase
Pain Drug: Fentanyl Drug: Oxycodone/acetaminophen Drug: oxycodone/acetaminophen Phase 3

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain: The FAIRTOP II Trial
Study Start Date : May 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Fentora 100 mcg buccal tablet
Experimental: High-FBT
Subject will receive the high dose regimen of FBT and a high dose placebo
Drug: Fentanyl
Fentanyl buccal tablet 200 mcg once
Other Name: 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 Name: 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 Name: Percocet 5/325

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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).

  2. Number of Participants Experiencing Any Adverse Events [ Time Frame: Full 2 hours of the study period ]
    Occurrence of any adverse event.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01270659

United States, Oklahoma
Hillcrest Medical Center Emergency Department
Tulsa, Oklahoma, United States, 74104
Sponsors and Collaborators
University of Oklahoma
Principal Investigator: Stephen H Thomas, MD MPH University of Oklahoma
Study Director: Annette O Arthur, PharmD University of Oklahoma

Responsible Party: University of Oklahoma Identifier: NCT01270659     History of Changes
Other Study ID Numbers: 1774
First Posted: January 5, 2011    Key Record Dates
Results First Posted: June 20, 2017
Last Update Posted: June 20, 2017
Last Verified: May 2017

Keywords provided by University of Oklahoma:
Fentanyl buccal tablet

Additional relevant MeSH terms:
Acetaminophen, hydrocodone drug combination
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents