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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Recruitment Status : Withdrawn (Sponsor elected not to continue with study.)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

Tracking Information
First Submitted Date  ICMJE May 12, 2014
First Posted Date  ICMJE May 14, 2014
Last Update Posted Date January 4, 2018
Estimated Study Start Date  ICMJE December 30, 2017
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2014)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2014)
Sedation scored on a scale from 0 to 4, where 0 = awake/alert and 4 = unarousable [ Time Frame: within 24 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fentanyl Sublingual Spray for the Treatment of Acute Procedure-related Pain in a Monitored Setting
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain
Intervention  ICMJE
  • 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®
  • Drug: Placebo Sublingual Spray (PSS)
    Placebo sublingual spray (PSS) packaged to match FSS, but deliver no drug
Study Arms  ICMJE
  • 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
    Intervention: Drug: Fentanyl Sublingual Spray (FSS)
  • 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
    Intervention: Drug: Fentanyl Sublingual Spray (FSS)
  • 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
    Intervention: Drug: Fentanyl Sublingual Spray (FSS)
  • 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
    Intervention: Drug: Placebo Sublingual Spray (PSS)
  • 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
    Intervention: Drug: Placebo Sublingual Spray (PSS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 21, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 12, 2014)
60
Estimated Study Completion Date  ICMJE January 2018
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT02138409
Other Study ID Numbers  ICMJE INS-13-021
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party INSYS Therapeutics Inc
Study Sponsor  ICMJE INSYS Therapeutics Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Giovanni DeCastro INSYS Therapeutics Inc
PRS Account INSYS Therapeutics Inc
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP