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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Pain

Intervention / Treatment
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* Drug: Morphine 6 mg
* Drug: Fentanyl 100 µg
* Drug: Fentanyl 200 µg
* Drug: Fentanyl 400 µg
* Drug: Placebo Sublingual Spray
* Drug: Intravenous Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Morphine 6 mg<br>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<br>* Intravenous infusion - delivering morphine 6 mg<br>* Other names: Standard of Care;Drug: Placebo Sublingual Spray<br>* Matching sublingual spray - single unit delivering 0 µg fentanyl<br>* Other names: PSS;|
| Experimental: Fentanyl 100 µg<br>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<br>* Fentanyl sublingual spray - single unit delivering 100 µg fentanyl<br>* Other names: SUBSYS®;Drug: Intravenous Placebo<br>* Matching intravenous infusion - delivering 0 mg morphine<br>* Other names: IVP;|
| Experimental: Fentanyl 200 µg<br>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<br>* Fentanyl sublingual spray - single unit delivering 200 µg fentanyl<br>* Other names: SUBSYS®;Drug: Intravenous Placebo<br>* Matching intravenous infusion - delivering 0 mg morphine<br>* Other names: IVP;|
| Experimental: Fentanyl 400 µg<br>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<br>* Fentanyl sublingual spray - single unit delivering 400 µg fentanyl<br>* Other names: SUBSYS®;Drug: Intravenous Placebo<br>* Matching intravenous infusion - delivering 0 mg morphine<br>* Other names: IVP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants requiring additional doses of randomized pain medication |  | at 30 minutes after initial treatment | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |