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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Oklahoma
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01270659
First received: January 4, 2011
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Pain
Drug: Fentanyl
Drug: Oxycodone/acetaminophen
Drug: oxycodone/acetaminophen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain: The FAIRTOP II Trial

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Pain Level [ Time Frame: every 5 minutes for 60 minutes ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Nausea level [ Time Frame: every 5 minutes for the first 60 minutes ] [ Designated as safety issue: No ]
    Subjects nausea level will be recorded to determine how fentanyl buccal tablet compares to standard therapy in causing nausea

  • Occurrence of adverse events [ Time Frame: the full 2 hours of the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: October 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01270659

Contacts
Contact: Annette O Arthur, PharmD 918-579-2362 annette-arthur@ouhsc.edu
Contact: Stephen H Thomas, MD MPH 918-660-3458 stephen-thomas@ouhsc.edu

Locations
United States, Oklahoma
Hillcrest Medical Center Emergency Department Recruiting
Tulsa, Oklahoma, United States, 74104
Contact: Stephen H Thomas, MD MPH       stephen-thomas@ouhsc.edu   
Principal Investigator: Stephen H Thomas, MD MPH         
Sub-Investigator: Annette O Arthur, PharmD         
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Stephen H Thomas, MD MPH University of Oklahoma
Study Director: Annette O Arthur, PharmD University of Oklahoma
  More Information

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01270659     History of Changes
Other Study ID Numbers: OUDEM 2010-12
Study First Received: January 4, 2011
Last Updated: December 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Oklahoma:
Fentanyl buccal tablet

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

ClinicalTrials.gov processed this record on September 22, 2014