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

• Status: Withdrawn
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: INSYS Therapeutics Inc
• Treatments: Fentanyl

Criteria

Inclusion Criteria:

• Has scheduled an interventional procedure for treatment of pain without sedation

• Has cleared pre-operative assessment

• Is able to read or understand informed consent form, and gives consent to participate in the study

Exclusion Criteria:

• Is taking any form of fentanyl

• Has oral pathology that would prevent effective absorption of study medication

• Was treated with an investigational drug within protocol-specified parameters

• Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1) the safety or well-being of the participant or study staff, 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding), 3) the analysis of results