Study Stopped
Study was never initiated
Study to Explore Effectiveness of Sublingual Fentanyl Spray in Emergency Department Patients With Acute Pain
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
1 other identifier
interventional
N/A
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2014
CompletedFirst Posted
Study publicly available on registry
May 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2017
CompletedJuly 5, 2017
June 1, 2017
May 12, 2014
June 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of participants requiring additional doses of randomized pain medication
at 30 minutes after initial treatment
Secondary Outcomes (9)
Percentage of participants requiring additional doses of randomized pain medication at secondary time points
within 120 minutes after initial treatment
Visual analogue scale (VAS) Summed Pain Intensity Difference (SPID) calculated as Area under the Curve (AUC) every 30 minutes
from baseline through 120 minutes after the initial dose of investigational product
Number of Investigational Product (IP) administrations
within 120 minutes after initial treatment
Time to onset of pain relief (in minutes) using the stopwatch method
within 120 minutes after first treatment
Richmond Agitation Sedation Scale (RASS) score
within 120 minutes after first treatment
- +4 more secondary outcomes
Study Arms (4)
Morphine 6 mg
ACTIVE COMPARATORPlacebo Sublingual Spray (PSS) + Intravenous Morphine (IVM 6 mg), every 30 minutes for two hours as needed (or until rescue), maximum exposure morphine 30 mg
Fentanyl 100 µg
EXPERIMENTALIntravenous 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 200 µg
EXPERIMENTALIntravenous 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 400 µg
EXPERIMENTALIntravenous Placebo (IVP) + Fentanyl Sublingual Spray (FSS 400 µg), every 30 minutes for two hours as needed (or until rescue), maximum exposure fentanyl 2000 µg
Interventions
Intravenous infusion - delivering morphine 6 mg
Fentanyl sublingual spray - single unit delivering 100 µg fentanyl
Fentanyl sublingual spray - single unit delivering 200 µg fentanyl
Fentanyl sublingual spray - single unit delivering 400 µg fentanyl
Matching sublingual spray - single unit delivering 0 µg fentanyl
Matching intravenous infusion - delivering 0 mg morphine
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Maricopa Medical Center
Phoenix, Arizona, 85008, United States
Olive View-UCLA Medical Center
Sylmar, California, 91342, United States
Kansas University Medical Center
Kansas City, Kansas, 66160, United States
Henry Ford Hospital
Detroit, Michigan, 48021, United States
Wayne State University School of Medicine
Detroit, Michigan, 48201, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Washington University
St Louis, Missouri, 63110, United States
Stony Brook University HSC
Stony Brook, New York, 11794, United States
Duke University School of Medicine
Durham, North Carolina, 27710, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Giovanni DeCastro
INSYS Therapeutics Inc
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2014
First Posted
May 14, 2014
Primary Completion
June 29, 2017
Last Updated
July 5, 2017
Record last verified: 2017-06