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

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ClinicalTrials.gov Identifier: NCT02138409
Recruitment Status : Withdrawn (Sponsor elected not to continue with study.)
First Posted : May 14, 2014
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc

Study Description
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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.


Condition or disease Intervention/treatment Phase
Chronic Pain Drug: Fentanyl Sublingual Spray (FSS) Drug: Placebo Sublingual Spray (PSS) Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 30, 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Drug: Fentanyl Sublingual Spray (FSS)
Fentanyl sublingual spray (FSS) packaged to deliver 100 µg/spray, 200 µg/spray or 400 µg/spray
Other Name: SUBSYS®
Experimental: 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
 Drug: Fentanyl Sublingual Spray (FSS)
Fentanyl sublingual spray (FSS) packaged to deliver 100 µg/spray, 200 µg/spray or 400 µg/spray
Other Name: SUBSYS®
Experimental: 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
 Drug: Fentanyl Sublingual Spray (FSS)
Fentanyl sublingual spray (FSS) packaged to deliver 100 µg/spray, 200 µg/spray or 400 µg/spray
Other Name: SUBSYS®
Placebo Comparator: 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
 Drug: Placebo Sublingual Spray (PSS)
Placebo sublingual spray (PSS) packaged to match FSS, but deliver no drug
Placebo Comparator: 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
 Drug: Placebo Sublingual Spray (PSS)
Placebo sublingual spray (PSS) packaged to match FSS, but deliver no drug


Outcome Measures
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Primary Outcome Measures :
  1. Pain scored on a scale from 0 to 10, where 0 = no pain and 10 = the most intense pain imaginable [ Time Frame: within 24 hours ]

Secondary Outcome Measures :
  1. Sedation scored on a scale from 0 to 4, where 0 = awake/alert and 4 = unarousable [ Time Frame: within 24 hours ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138409


Sponsors and Collaborators
INSYS Therapeutics Inc
Investigators
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Study Director: Giovanni DeCastro INSYS Therapeutics Inc
More Information
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Responsible Party: INSYS Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02138409    
Other Study ID Numbers: INS-13-021
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics