Acute Pain
Conditions
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.
Interventions
DRUGMorphine 6 mg
Intravenous infusion - delivering morphine 6 mg
DRUGFentanyl 100 µg
Fentanyl sublingual spray - single unit delivering 100 µg fentanyl
DRUGFentanyl 200 µg
Fentanyl sublingual spray - single unit delivering 200 µg fentanyl
DRUGFentanyl 400 µg
Fentanyl sublingual spray - single unit delivering 400 µg fentanyl
Matching sublingual spray - single unit delivering 0 µg fentanyl
DRUGIntravenous Placebo
Matching intravenous infusion - delivering 0 mg morphine
Sponsors
INSYS Therapeutics Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants requiring additional doses of randomized pain medication | at 30 minutes after initial treatment |
Secondary
| Measure | Time frame |
|---|---|
| Time until rescue medication was required | during the 5-day study period |
| 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 |
| 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 |
| 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 |
| Percentage of participants requiring additional doses of randomized pain medication at secondary time points | within 120 minutes after initial treatment |
Countries
United States
Outcome results
None listed