Clinical trial NCT02138409: Fentanyl Sublingual Spray for the Treatment of Acute Procedure-related Pain in a Monitored Setting
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Chronic Pain
Lead sponsor: INSYS Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2014-05-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Pain scored on a scale from 0 to 10, where 0 = no pain and 10 = the most intense pain imaginable
timeFrame: within 24 hours
Secondary outcomes:
measure: Sedation scored on a scale from 0 to 4, where 0 = awake/alert and 4 = unarousable
timeFrame: within 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: INSYS Therapeutics Inc
name: Giovanni DeCastro
role: STUDY_DIRECTOR
References: