drugset / Trial / NCT02137525

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

NCT02137525

Phase 2 Withdrawn INSYS Therapeutics Inc
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
Primary completion
2017-06-29
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Fentanyl Other / unclassified 100 ug Other
Subject Fentanyl Other / unclassified 200 ug Other
Subject Fentanyl Other / unclassified 400 ug Other
Comparator Morphine Other / unclassified 6 mg Intravenous

Indications

No indication recorded.