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

NCT01270659 | Completed Phase 3 Results DMC

• 1 other identifier: 1774
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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"

Conditions

Pain

Keywords

Fentanyl buccal tablet

Outcome Measures

Primary Outcomes (1)

• Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level)

  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 Outcomes (2)

• Nausea Level

  every 5 minutes for the first 60 minutes

• Number of Participants Experiencing Any Adverse Events

  Full 2 hours of the study period

Study Arms (4)

Low-FBT

EXPERIMENTAL

Subject will receive FBT and placebo at a low dose

Drug: Fentanyl

High-FBT

EXPERIMENTAL

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

Drug: Fentanyl

Low control

ACTIVE COMPARATOR

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

Drug: Oxycodone/acetaminophen

High control

ACTIVE COMPARATOR

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

Interventions

Fentanyl DRUG

Fentanyl buccal tablet 100 mcg once

Also known as: Fentora 100 mcg buccal tablet

Low-FBT

oxycodone/acetaminophen DRUG

Oxycodone/acetaminophen 5/325 mg once

Also known as: Percocet 5/325

Low control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Hillcrest Medical Center Emergency Department

Tulsa, Oklahoma, 74104, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Fentanyl; oxycodone-acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Nasir Mushtaw
• Organization: University of Oklahoma Health Sciences Center Tulsa

Nasir-Mushtaq@ouhsc.edu

918/660-3680

Study Officials

• Stephen H Thomas, MD MPH

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

• Annette O Arthur, PharmD

  University of Oklahoma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2011
• First Posted: January 5, 2011
• Study Start: May 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: June 20, 2017
• Results First Posted: June 20, 2017

Record last verified: 2017-05

Locations

US (1)