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

Information source: INSYS Therapeutics Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Pain

Intervention: Morphine 6 mg (Drug); Fentanyl 100 µg (Drug); Fentanyl 200 µg (Drug); Fentanyl 400 µg (Drug); Placebo Sublingual Spray (Drug); Intravenous Placebo (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: INSYS Therapeutics Inc

Official(s) and/or principal investigator(s):
Giovanni DeCastro, Study Director, Affiliation: INSYS Therapeutics Inc

Overall contact:
Melissa Ortiz Alvidrez, Phone: 1-512.351.9805

Summary

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percentage of participants requiring additional doses of randomized pain medication

Secondary outcome:

Percentage of participants requiring additional doses of randomized pain medication at secondary time points

Visual analogue scale (VAS) Summed Pain Intensity Difference (SPID) calculated as Area under the Curve (AUC) every 30 minutes

Number of Investigational Product (IP) administrations

Time to onset of pain relief (in minutes) using the stopwatch method

Richmond Agitation Sedation Scale (RASS) score

Percentage of Participants requiring rescue medication

Time until rescue medication was required

Percentage of participants experiencing a treatment-related adverse event

Percentage of participants with clinically significant changes in vital signs

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Melissa Ortiz Alvidrez, Phone: 1-512.351.9805

Maricopa Medical Center, Phoeniz, Arizona 85008, United States; Not yet recruiting
Mary Mulrow, RN, Phone: 602-344-5058, Email: mary.mulrow@mich.org
Frank Lovecchio, MD, Principal Investigator

Olive View-UCLA Medical Center, Sylmar, California 91342, United States; Not yet recruiting
Kavitha Pathmarajah, Phone: 818-364-3115, Email: kpathmar@gmail.com
Pamela Pathmarajah, Principal Investigator

Kansas University Medical Center, Kansas City, Kansas 66160, United States; Not yet recruiting
Jeannie M Whipple, Phone: 913-588-4643, Email: jwhipple@kumc.edu
Chad Cannon, MD, Principal Investigator

Henry Ford Hospital, Detroit, Michigan 48021, United States; Not yet recruiting
Michael Berthume, Phone: 313-916-8464, Email: mberthu1@hfhs.org
Rich Nowak, MD, Principal Investigator

Wayne State University School of Medicine, Detroit, Michigan 48201, United States; Not yet recruiting
Patrick Medado, Phone: 313-745-4621, Email: pbmedado@med.wayne.edu
John Wilburn, MD, Principal Investigator

Hennepin County Medical Center, Minneapolis, Minnesota 55415, United States; Not yet recruiting
Audrey Hendrickson, MPH, CCRP, Phone: 612-624-8833, Email: audrey.hendrickson@hcmed.org
James Miner, MD, Principal Investigator

Washington University, St Louis, Missouri 63110, United States; Not yet recruiting
Catherine Richard, BSN, Phone: 314-362-5570, Email: richardc@wusm.wusti.edu
Stacy House, MD, Principal Investigator

Stony Brook University HSC, Stony Brook, New York 11794, United States; Not yet recruiting
Maria Taylor, RN, Phone: 631-444-2499, Email: maria.taylor@stonybrookmedicine.edu
Adam Singer, MD, Principal Investigator

Duke University School of Medicine, Durham, North Carolina 27710, United States; Not yet recruiting
Drake Weiying, Phone: 919-681-0907, Email: weiying.gao@duke.edu
Caroline Freiermuth, MD, Principal Investigator

University of Cincinnati, Cincinnati, Ohio 45267, United States; Not yet recruiting
Jillian Picard, RN, BSN, Phone: 513-558-8983, Email: picardjk@ucmail.uc.edu
Gregory Gregory Fermann, MD, Principal Investigator

Pennsylvania Hospital, Philadelphia, Pennsylvania 19107, United States; Not yet recruiting
Jim Lynch, Phone: 215-829-7549, Email: jmjsst@verizon.net
Charles Pollack, MD, Principal Investigator

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania 19107, United States; Not yet recruiting
Laura Costelloe, NP, Phone: 410-419-6889, Email: laura.costelloe@jefferson.edu
Judd Hollander, MD, Principal Investigator

Vanderbilt University, Nashville, Tennessee 37232, United States; Not yet recruiting
Kelly Moser, BS, Phone: 615-936-2651, Email: kelly.moser@vanderbilt.edu
Wesley Self, MD, Principal Investigator

Baylor College of Medicine, Houston, Texas 77030, United States; Not yet recruiting
Kelly Rogers Keene, RN, Phone: 713-873-7042, Email: kelly.keene@bcm.edu
Zubaid Rafique, Principal Investigator

University of Virginia Health System, Charlottesville, Virginia 22908, United States; Not yet recruiting
Elaine Dube, Phone: 434-243-8603, Email: ED7Y@hscmail.mcc.virginia.edu
Mark Sochor, MD, Principal Investigator

Additional Information

Starting date: May 2016
Last updated: July 20, 2015

Page last updated: August 23, 2015

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