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

Acute Pain Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02137525
Study type Interventional
Source INSYS Therapeutics Inc
Contact
Status Withdrawn
Phase Phase 2
View Details
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