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

NCT01270659 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-06-20

Study results available
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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

Interventions

DRUG

Fentanyl

Fentanyl buccal tablet 100 mcg once

DRUG

Fentanyl

Fentanyl buccal tablet 200 mcg once

DRUG

Oxycodone/acetaminophen

Oxycodone/acetaminophen 5/325 mg once

DRUG

oxycodone/acetaminophen

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

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Stephen H Thomas, MD MPH · University of Oklahoma

  • Annette O Arthur, PharmD · University of Oklahoma

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01270659 on ClinicalTrials.gov