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.
Verified February 2012 by University of Oklahoma
Sponsor:
Stephen Thomas
Collaborator:
University of Oklahoma
Information provided by (Responsible Party):
Stephen Thomas, University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01270659
First received: January 4, 2011
Last updated: February 14, 2012
Last verified: February 2012
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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:
Drug Information available for:
Oxycodone
Acetaminophen
Oxycodone hydrochloride
Fentanyl
Fentanyl citrate
U.S. FDA Resources
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: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01270659
Contacts
| Contact: Annette O Arthur, PharmD | 918-66-3458 | 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
Stephen Thomas
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: | Stephen Thomas, Kaiser Chair & Professor Department of Emergency Medicine, 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: | February 14, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Oklahoma:
|
Fentanyl buccal tablet |
Additional relevant MeSH terms:
|
Acetaminophen Acetaminophen, hydrocodone drug combination Fentanyl Oxycodone Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents |
Therapeutic Uses Adjuvants, Anesthesia Narcotics Central Nervous System Depressants Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Opioid Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 22, 2013