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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-30

Study Completion Date

2018-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ON FSS 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 100 µg

Group Type EXPERIMENTAL

Fentanyl Sublingual Spray (FSS)

Intervention Type DRUG

Fentanyl sublingual spray (FSS) packaged to deliver 100 µg/spray, 200 µg/spray or 400 µg/spray

ON FSS 200 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

Group Type EXPERIMENTAL

Fentanyl Sublingual Spray (FSS)

Intervention Type DRUG

Fentanyl sublingual spray (FSS) packaged to deliver 100 µg/spray, 200 µg/spray or 400 µg/spray

OE FSS 400 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

Group Type EXPERIMENTAL

Fentanyl Sublingual Spray (FSS)

Intervention Type DRUG

Fentanyl sublingual spray (FSS) packaged to deliver 100 µg/spray, 200 µg/spray or 400 µg/spray

ON PSS

Participants classified as opioid-naïve (ON) and randomized to receive one dose of matching placebo sublingual spray (PSS) 10 minutes before treatment procedure

Group Type PLACEBO_COMPARATOR

Placebo Sublingual Spray (PSS)

Intervention Type DRUG

Placebo sublingual spray (PSS) packaged to match FSS, but deliver no drug

OE PSS

Participants classified as opioid-experienced (OE) and randomized to receive one dose of matching placebo sublingual spray (PSS) 10 minutes before treatment procedure

Group Type PLACEBO_COMPARATOR

Placebo Sublingual Spray (PSS)

Intervention Type DRUG

Placebo sublingual spray (PSS) packaged to match FSS, but deliver no drug

Interventions

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Fentanyl Sublingual Spray (FSS)

Fentanyl sublingual spray (FSS) packaged to deliver 100 µg/spray, 200 µg/spray or 400 µg/spray

Intervention Type DRUG

Placebo Sublingual Spray (PSS)

Placebo sublingual spray (PSS) packaged to match FSS, but deliver no drug

Intervention Type DRUG

Other Intervention Names

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SUBSYS®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No