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

NCT02138409 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: INS-13-021
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Pain scored on a scale from 0 to 10, where 0 = no pain and 10 = the most intense pain imaginable

  within 24 hours

Secondary Outcomes (1)

• Sedation scored on a scale from 0 to 4, where 0 = awake/alert and 4 = unarousable

  within 24 hours

Study Arms (5)

ON FSS 100 µg

EXPERIMENTAL

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)

ON FSS 200 µg

EXPERIMENTAL

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)

OE FSS 400 µg

EXPERIMENTAL

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)

ON PSS

PLACEBO COMPARATOR

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)

OE PSS

PLACEBO COMPARATOR

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)

Interventions

Fentanyl Sublingual Spray (FSS) DRUG

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

Also known as: SUBSYS®

OE FSS 400 µg; ON FSS 100 µg; ON FSS 200 µg

Placebo Sublingual Spray (PSS) DRUG

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

OE PSS; ON PSS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• INSYS Therapeutics Inc: lead

MeSH Terms

Conditions

Chronic Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Giovanni DeCastro

  INSYS Therapeutics Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 14, 2014
• Study Start: December 30, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: January 4, 2018

Record last verified: 2018-01