Fentanyl Sublingual Spray for the Treatment of Acute Procedure-related Pain in a Monitored Setting
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Chronic Pain, Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/7/2017 |
| Start Date: | December 30, 2017 |
| End Date: | January 2018 |
| Contact: | Clinical Operations |
| Email: | InsysCBD@insysrx.com |
| Phone: | (602) 910-2617 |
A Pilot, Randomized, Double-blind, Placebo-controlled Single-center Study to Evaluate the Safety and Efficacy of SUBSYS™ (Fentanyl Sublingual Spray) for the Treatment of Acute Procedure-related Pain in a Monitored Setting
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.
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.
Participants will be separated into opioid-experienced and opioid-naïve groups. Participants
in each group will be randomly allocated in a 3:1 ratio to receive fentanyl sublingual spray
(FSS) or a matching placebo sublingual spray (PSS) 10 minutes before the scheduled procedure.
Based on FDA guidelines, opioid-experienced FSS participants will receive FSS 400 µg, and
opioid-naïve FSS participants will be further randomized in a 1:1 ratio to receive either 100
µg or 200 µg. All participants randomized to placebo receive the same matching PSS,
regardless of opioid experience. Pain and sedation will be recorded multiple times during the
scheduled procedure. If rescue medication is needed during the procedure, local anesthetic
standard of care for the procedure will be administered and recorded in the study record.
Efficacy and safety/tolerability of fentanyl sublingual spray will be evaluated among and
between the treatment groups.
in each group will be randomly allocated in a 3:1 ratio to receive fentanyl sublingual spray
(FSS) or a matching placebo sublingual spray (PSS) 10 minutes before the scheduled procedure.
Based on FDA guidelines, opioid-experienced FSS participants will receive FSS 400 µg, and
opioid-naïve FSS participants will be further randomized in a 1:1 ratio to receive either 100
µg or 200 µg. All participants randomized to placebo receive the same matching PSS,
regardless of opioid experience. Pain and sedation will be recorded multiple times during the
scheduled procedure. If rescue medication is needed during the procedure, local anesthetic
standard of care for the procedure will be administered and recorded in the study record.
Efficacy and safety/tolerability of fentanyl sublingual spray will be evaluated among and
between the treatment groups.
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
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