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Study was never initiated
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morphine 6 mg | Active Comparator | 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 |
|
| Fentanyl 100 µg | Experimental | 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 200 µg | Experimental | 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 400 µg | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine 6 mg | Drug | Intravenous infusion - delivering morphine 6 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants requiring additional doses of randomized pain medication | at 30 minutes after initial treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giovanni DeCastro | INSYS Therapeutics Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maricopa Medical Center | Phoenix | Arizona | 85008 | United States | ||
| Olive View-UCLA Medical Center |
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| Fentanyl 100 µg | Drug | Fentanyl sublingual spray - single unit delivering 100 µg fentanyl |
|
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| Fentanyl 200 µg | Drug | Fentanyl sublingual spray - single unit delivering 200 µg fentanyl |
|
|
| Fentanyl 400 µg | Drug | Fentanyl sublingual spray - single unit delivering 400 µg fentanyl |
|
|
| Placebo Sublingual Spray | Drug | Matching sublingual spray - single unit delivering 0 µg fentanyl |
|
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| Intravenous Placebo | Drug | Matching intravenous infusion - delivering 0 mg morphine |
|
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| 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 |
| Percentage of Participants requiring rescue medication | during the 5-day study period |
| Time until rescue medication was required | during the 5-day study period |
| Percentage of participants experiencing a treatment-related adverse event | during the 5-day study period |
| Percentage of participants with clinically significant changes in vital signs | during the 5-day study period |
| 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 |
| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D000069416 | Intravital Microscopy |
| D059039 | Standard of Care |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D008853 | Microscopy |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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