NCT02137525

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: INSYS Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	Morphine 6 mg	Intravenous infusion - delivering morphine 6 mg
DRUG	Fentanyl 100 µg	Fentanyl sublingual spray - single unit delivering 100 µg fentanyl
DRUG	Fentanyl 200 µg	Fentanyl sublingual spray - single unit delivering 200 µg fentanyl
DRUG	Fentanyl 400 µg	Fentanyl sublingual spray - single unit delivering 400 µg fentanyl
DRUG	Placebo Sublingual Spray	Matching sublingual spray - single unit delivering 0 µg fentanyl
DRUG	Intravenous Placebo	Matching intravenous infusion - delivering 0 mg morphine

Timeline

• Primary completion: 2017-06-29
• First posted: 2014-05-14
• Last updated: 2017-07-05

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study