Study to Explore Effectiveness of Sublingual Fentanyl Spray in Emergency Department Patients With Acute Pain
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Chronic Pain, Hospital |
| Therapuetic Areas: | Musculoskeletal, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 6/1/2017 |
| Start Date: | June 30, 2017 |
| End Date: | December 2017 |
| Contact: | Melissa Ortiz Alvidrez |
| Email: | insyscbd@insysrx.com |
| Phone: | 1-512.351.9805 |
A Randomized, Multicenter, Double-Blind, Double Dummy, Active Comparator, Dose-Ranging Study to Explore the Efficacy of SUBSYS® in Emergency Department Patients With Acute Pain
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
15
sites
2600 Clifton Ave
Cincinnati, Ohio 45267
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Gregory Gregory Fermann, MD
Phone: 513-558-8983
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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1200 Moursund Street
Houston, Texas 77030
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Zubaid Rafique
Phone: 713-873-7042
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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1215 Lee St
Charlottesville, Virginia 22903
Charlottesville, Virginia 22903
(434) 924-0211
Principal Investigator: Mark Sochor, MD
Phone: 434-243-8603
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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2799 W Grand Blvd
Detroit, Michigan 48202
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Rich Nowak, MD
Phone: 313-916-8464
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, Michigan 48201
Principal Investigator: John Wilburn, MD
Phone: 313-745-4621
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Durham, North Carolina 27710
Principal Investigator: Caroline Freiermuth, MD
Phone: 919-681-0907
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Kansas City, Kansas
Principal Investigator: Chad Cannon, MD
Phone: 913-588-4643
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Minneapolis, Minnesota 55414
Principal Investigator: James Miner, MD
Phone: 612-624-8833
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2201 West End Ave
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-7311
Principal Investigator: Wesley Self, MD
Phone: 615-936-2651
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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800 Spruce St
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
215-829-3000
Principal Investigator: Charles Pollack, MD
Phone: 215-829-7549
Pennsylvania Hospital Pennsylvania Hospital, the nation's first hospital, has been a leader in patient care,...
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111 S 11th St
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Judd Hollander, MD
Phone: 410-419-6889
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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Phoenix, Arizona 85008
Principal Investigator: Frank Lovecchio, MD
Phone: 602-344-5058
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Saint Louis, Missouri 63110
Principal Investigator: Stacy House, MD
Phone: 314-362-5570
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Stony Brook, New York 11794
Principal Investigator: Adam Singer, MD
Phone: 631-444-2499
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Sylmar, California 91342
Principal Investigator: Pamela Pathmarajah
Phone: 818-364-3115
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