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

• ClinicalTrials.gov Identifier: NCT02138409
• Recruitment Status: Withdrawn
• First Posted: May 14, 2014
• Last Update Posted: January 4, 2018
• Sponsor: INSYS Therapeutics Inc
• Information provided by (Responsible Party): INSYS Therapeutics Inc

Tracking Information

• First Submitted Date: May 12, 2014
• First Posted Date: May 14, 2014
• Last Update Posted Date: January 4, 2018
• Estimated Study Start Date: December 30, 2017
• Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Chronic Pain

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: December 21, 2017): 0
• Original Estimated Enrollment (submitted: May 12, 2014): 60
• Estimated Study Completion Date: January 2018
• Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT02138409
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: INSYS Therapeutics Inc
• Study Sponsor: INSYS Therapeutics Inc
• Collaborators: Not Provided

Investigators

• Study Director: Giovanni DeCastro; INSYS Therapeutics Inc

• PRS Account: INSYS Therapeutics Inc
• Verification Date: January 2018