Study to Explore Effectiveness of Sublingual Fentanyl Spray in Emergency Department Patients With Acute Pain
NCT ID: NCT02137525
Last Updated: 2017-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Morphine 6 mg
Placebo Sublingual Spray (PSS) + Intravenous Morphine (IVM 6 mg), every 30 minutes for two hours as needed (or until rescue), maximum exposure morphine 30 mg
Morphine 6 mg
Intravenous infusion - delivering morphine 6 mg
Placebo Sublingual Spray
Matching sublingual spray - single unit delivering 0 µg fentanyl
Fentanyl 100 µg
Intravenous Placebo (IVP) + Fentanyl Sublingual Spray (FSS 100 µg), every 30 minutes for two hours as needed (or until rescue), maximum exposure fentanyl 500 µg
Fentanyl 100 µg
Fentanyl sublingual spray - single unit delivering 100 µg fentanyl
Intravenous Placebo
Matching intravenous infusion - delivering 0 mg morphine
Fentanyl 200 µg
Intravenous Placebo (IVP) + Fentanyl Sublingual Spray (FSS 200 µg), every 30 minutes for two hours as needed (or until rescue), maximum exposure fentanyl 1000 µg
Fentanyl 200 µg
Fentanyl sublingual spray - single unit delivering 200 µg fentanyl
Intravenous Placebo
Matching intravenous infusion - delivering 0 mg morphine
Fentanyl 400 µg
Intravenous Placebo (IVP) + Fentanyl Sublingual Spray (FSS 400 µg), every 30 minutes for two hours as needed (or until rescue), maximum exposure fentanyl 2000 µg
Fentanyl 400 µg
Fentanyl sublingual spray - single unit delivering 400 µg fentanyl
Intravenous Placebo
Matching intravenous infusion - delivering 0 mg morphine
Interventions
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Morphine 6 mg
Intravenous infusion - delivering morphine 6 mg
Fentanyl 100 µg
Fentanyl sublingual spray - single unit delivering 100 µg fentanyl
Fentanyl 200 µg
Fentanyl sublingual spray - single unit delivering 200 µg fentanyl
Fentanyl 400 µg
Fentanyl sublingual spray - single unit delivering 400 µg fentanyl
Placebo Sublingual Spray
Matching sublingual spray - single unit delivering 0 µg fentanyl
Intravenous Placebo
Matching intravenous infusion - delivering 0 mg morphine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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INSYS Therapeutics Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Giovanni DeCastro
Role: STUDY_DIRECTOR
INSYS Therapeutics Inc
Locations
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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
Countries
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Other Identifiers
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INS-14-022
Identifier Type: -
Identifier Source: org_study_id
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