Fentanyl Sublingual Spray for the Treatment of Acute Procedure-related Pain in a Monitored Setting
Chronic Pain
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
ON FSS 100 µg
ON FSS 200 µg
OE FSS 400 µg
ON PSS
OE PSS
Participants classified as opioid-naïve (ON), randomized to receive one dose of fentanyl sublingual spray (FSS) 10 minutes before treatment procedure, and further randomized to a dose of 100 µg
Participants classified as opioid-naïve (ON), randomized to receive one dose of fentanyl sublingual spray (FSS) 10 minutes before treatment procedure, and further randomized to a dose of 200 µg
Participants classified as opioid-experienced (OE), randomized to receive one dose of fentanyl sublingual spray (FSS) 10 minutes before treatment procedure, at a dose of 400 µg
Participants classified as opioid-naïve (ON) and randomized to receive one dose of matching placebo sublingual spray (PSS) 10 minutes before treatment procedure
Participants classified as opioid-experienced (OE) and randomized to receive one dose of matching placebo sublingual spray (PSS) 10 minutes before treatment procedure