Study to Explore Effectiveness of Sublingual Fentanyl Spray in Emergency Department Patients With Acute Pain

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Acute Pain

In brief

This study will explore effectiveness of three doses of fentanyl sublingual spray against an active comparator in emergency department (ED) patients with acute pain. After screening, eligible participants will participate in a treatment period (up to 2 hours) and a post-treatment evaluation period (up to 4 hours or discharge from the ED). Open-label standard of care rescue medication for pain can be given at any time during the study period, based on clinical judgment of the treating physician. Adverse events will be collected for five days after initial enrollment.

Key facts

Study ID

NCT02137525

Run by

INSYS Therapeutics Inc

People needed

0

Last updated by the study team

2017-07-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is able to understand the language in which the study is being conducted and has provided meaningful written informed consent for the study
• Has an acute painful condition requiring parenteral analgesia as deemed necessary by the treating physician or physician extender
• Has a pain score within protocol-specified parameters

You may not qualify if…

• Has allergy to fentanyl or morphine
• Has oxygen-dependent conditions or oxygen saturation <95%
• Has planned or recent drug use outside protocol-specified parameters
• Has any condition that, in the principal investigator's opinion, would place the patient at risk or influence the conduct of the study or interpretation of results

Where it is running

• Maricopa Medical Center — Phoenix, Arizona, United States
• Olive View-UCLA Medical Center — Sylmar, California, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Wayne State University School of Medicine — Detroit, Michigan, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Stony Brook University HSC — Stony Brook, New York, United States
• Duke University School of Medicine — Durham, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Virginia Health System — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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