drugset / Trial / NCT02138409

Fentanyl Sublingual Spray for the Treatment of Acute Procedure-related Pain in a Monitored Setting

NCT02138409

Phase 3 Withdrawn INSYS Therapeutics Inc
RandomizedParallel-groupDouble-blindTreatment

Summary

Participants will be selected from patients who have been scheduled at the site for treatment of chronic pain without sedation. They will receive either fentanyl sublingual spray or a matching placebo sublingual spray that delivers no medication. Participants may take pain killers at any time after the procedure for pain relief. They will be given a diary card, which they will take home. They will record the name of the medication taken, the time, and dosage. The study coordinator will call participants about 24 hours after the procedure to collect information from the diary card and follow up information about pain and side effects (adverse events) after they left the site.

Timeline

Start
2017-12-30
Primary completion
2018-01
Completion
2018-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Fentanyl Other / unclassified 100 ug Other
Subject Fentanyl Other / unclassified 200 ug Other
Subject Fentanyl Other / unclassified 400 ug Other

Indications