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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-10-31

Brief Summary

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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"

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Low-FBT

Subject will receive FBT and placebo at a low dose

Group Type EXPERIMENTAL

Fentanyl

Intervention Type DRUG

Fentanyl buccal tablet 100 mcg once

High-FBT

Subject will receive the high dose regimen of FBT and a high dose placebo

Group Type EXPERIMENTAL

Fentanyl

Intervention Type DRUG

Fentanyl buccal tablet 200 mcg once

Low control

Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo"

Group Type ACTIVE_COMPARATOR

Oxycodone/acetaminophen

Intervention Type DRUG

Oxycodone/acetaminophen 5/325 mg once

High control

Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl "placebo"

Group Type ACTIVE_COMPARATOR

oxycodone/acetaminophen

Intervention Type DRUG

Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time

Interventions

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Fentanyl

Fentanyl buccal tablet 100 mcg once

Intervention Type DRUG

Fentanyl

Fentanyl buccal tablet 200 mcg once

Intervention Type DRUG

Oxycodone/acetaminophen

Oxycodone/acetaminophen 5/325 mg once

Intervention Type DRUG

oxycodone/acetaminophen

Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time

Intervention Type DRUG

Other Intervention Names

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Fentora 100 mcg buccal tablet Fentora buccal tablet 200 mcg Percocet 5/325 Percocet 5/325

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No