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

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ClinicalTrials.gov Identifier: NCT02137525
Recruitment Status : Withdrawn (Study was never initiated)
First Posted : May 14, 2014
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc

Brief 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.


Condition or disease Intervention/treatment Phase
Acute Pain Drug: Morphine 6 mg Drug: Fentanyl 100 µg Drug: Fentanyl 200 µg Drug: Fentanyl 400 µg Drug: Placebo Sublingual Spray Drug: Intravenous Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Primary Completion Date : June 29, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
Drug: Morphine 6 mg
Intravenous infusion - delivering morphine 6 mg
Other Names:
  • IVM 6 mg
  • Standard of Care

Drug: Placebo Sublingual Spray
Matching sublingual spray - single unit delivering 0 µg fentanyl
Other Name: PSS

Experimental: 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
Drug: Fentanyl 100 µg
Fentanyl sublingual spray - single unit delivering 100 µg fentanyl
Other Names:
  • FSS 100 µg
  • SUBSYS®

Drug: Intravenous Placebo
Matching intravenous infusion - delivering 0 mg morphine
Other Name: IVP

Experimental: 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
Drug: Fentanyl 200 µg
Fentanyl sublingual spray - single unit delivering 200 µg fentanyl
Other Names:
  • FSS 200 µg
  • SUBSYS®

Drug: Intravenous Placebo
Matching intravenous infusion - delivering 0 mg morphine
Other Name: IVP

Experimental: 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
Drug: Fentanyl 400 µg
Fentanyl sublingual spray - single unit delivering 400 µg fentanyl
Other Names:
  • FSS 400 µg
  • SUBSYS®

Drug: Intravenous Placebo
Matching intravenous infusion - delivering 0 mg morphine
Other Name: IVP




Primary Outcome Measures :
  1. Percentage of participants requiring additional doses of randomized pain medication [ Time Frame: at 30 minutes after initial treatment ]

Secondary Outcome Measures :
  1. Percentage of participants requiring additional doses of randomized pain medication at secondary time points [ Time Frame: within 120 minutes after initial treatment ]
  2. Visual analogue scale (VAS) Summed Pain Intensity Difference (SPID) calculated as Area under the Curve (AUC) every 30 minutes [ Time Frame: from baseline through 120 minutes after the initial dose of investigational product ]
  3. Number of Investigational Product (IP) administrations [ Time Frame: within 120 minutes after initial treatment ]
  4. Time to onset of pain relief (in minutes) using the stopwatch method [ Time Frame: within 120 minutes after first treatment ]
  5. Richmond Agitation Sedation Scale (RASS) score [ Time Frame: within 120 minutes after first treatment ]
  6. Percentage of Participants requiring rescue medication [ Time Frame: during the 5-day study period ]
  7. Time until rescue medication was required [ Time Frame: during the 5-day study period ]
  8. Percentage of participants experiencing a treatment-related adverse event [ Time Frame: during the 5-day study period ]
  9. Percentage of participants with clinically significant changes in vital signs [ Time Frame: during the 5-day study period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02137525


Locations
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United States, Arizona
Maricopa Medical Center
Phoenix, Arizona, United States, 85008
United States, California
Olive View-UCLA Medical Center
Sylmar, California, United States, 91342
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48021
Wayne State University School of Medicine
Detroit, Michigan, United States, 48201
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, New York
Stony Brook University HSC
Stony Brook, New York, United States, 11794
United States, North Carolina
Duke University School of Medicine
Durham, North Carolina, United States, 27710
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
INSYS Therapeutics Inc
Investigators
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Study Director: Giovanni DeCastro INSYS Therapeutics Inc

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Responsible Party: INSYS Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02137525     History of Changes
Other Study ID Numbers: INS-14-022
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Acute Pain
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Fentanyl
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics