Study to Explore Effectiveness of Sublingual Fentanyl Spray in Emergency Department Patients With Acute Pain

A Randomized, Multicenter, Double-Blind, Double Dummy, Active Comparator, Dose-Ranging Study to Explore the Efficacy of SUBSYS® in Emergency Department Patients With Acute Pain

This study will explore effectiveness of three doses of fentanyl sublingual spray against an active comparator in emergency department (ED) patients with acute pain.

After screening, eligible participants will participate in a treatment period (up to 2 hours) and a post-treatment evaluation period (up to 4 hours or discharge from the ED). Open-label standard of care rescue medication for pain can be given at any time during the study period, based on clinical judgment of the treating physician.

Adverse events will be collected for five days after initial enrollment.

Study Overview

• Status: Withdrawn
• Conditions: Acute Pain
• Intervention / Treatment: Drug: Morphine 6 mg; Drug: Placebo Sublingual Spray; Drug: Fentanyl 100 µg; Drug: Intravenous Placebo; Drug: Fentanyl 200 µg; Drug: Fentanyl 400 µg

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85008
      • Maricopa Medical Center
  • California
    • Sylmar, California, United States, 91342
      • Olive View-UCLA Medical Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kansas University Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University School of Medicine
    • Detroit, Michigan, United States, 48021
      • Henry Ford Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University HSC
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University School of Medicine
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital
    • Philadelphia, Pennsylvania, United States, 19107
      • Pennsylvania Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Is able to understand the language in which the study is being conducted and has provided meaningful written informed consent for the study
• Has an acute painful condition requiring parenteral analgesia as deemed necessary by the treating physician or physician extender
• Has a pain score within protocol-specified parameters

Exclusion Criteria:

• Has allergy to fentanyl or morphine
• Has oxygen-dependent conditions or oxygen saturation <95%
• Has planned or recent drug use outside protocol-specified parameters
• Has any condition that, in the principal investigator's opinion, would place the patient at risk or influence the conduct of the study or interpretation of results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Morphine 6 mg; Placebo Sublingual Spray (PSS) + Intravenous Morphine (IVM 6 mg), every 30 minutes for two hours as needed (or until rescue), maximum exposure morphine 30 mg	Drug: Morphine 6 mg; Intravenous infusion - delivering morphine 6 mg; Other Names: Standard of Care; IVM 6 mg; Drug: Placebo Sublingual Spray; Matching sublingual spray - single unit delivering 0 µg fentanyl; Other Names: PSS
Experimental: Fentanyl 100 µg; Intravenous Placebo (IVP) + Fentanyl Sublingual Spray (FSS 100 µg), every 30 minutes for two hours as needed (or until rescue), maximum exposure fentanyl 500 µg	Drug: Fentanyl 100 µg; Fentanyl sublingual spray - single unit delivering 100 µg fentanyl; Other Names: SUBSYS®; FSS 100 µg; Drug: Intravenous Placebo; Matching intravenous infusion - delivering 0 mg morphine; Other Names: IVP
Experimental: Fentanyl 200 µg; Intravenous Placebo (IVP) + Fentanyl Sublingual Spray (FSS 200 µg), every 30 minutes for two hours as needed (or until rescue), maximum exposure fentanyl 1000 µg	Drug: Intravenous Placebo; Matching intravenous infusion - delivering 0 mg morphine; Other Names: IVP; Drug: Fentanyl 200 µg; Fentanyl sublingual spray - single unit delivering 200 µg fentanyl; Other Names: SUBSYS®; FSS 200 µg
Experimental: Fentanyl 400 µg; Intravenous Placebo (IVP) + Fentanyl Sublingual Spray (FSS 400 µg), every 30 minutes for two hours as needed (or until rescue), maximum exposure fentanyl 2000 µg	Drug: Intravenous Placebo; Matching intravenous infusion - delivering 0 mg morphine; Other Names: IVP; Drug: Fentanyl 400 µg; Fentanyl sublingual spray - single unit delivering 400 µg fentanyl; Other Names: SUBSYS®; FSS 400 µg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants requiring additional doses of randomized pain medication	at 30 minutes after initial treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants requiring additional doses of randomized pain medication at secondary time points	within 120 minutes after initial treatment
Visual analogue scale (VAS) Summed Pain Intensity Difference (SPID) calculated as Area under the Curve (AUC) every 30 minutes	from baseline through 120 minutes after the initial dose of investigational product
Number of Investigational Product (IP) administrations	within 120 minutes after initial treatment
Time to onset of pain relief (in minutes) using the stopwatch method	within 120 minutes after first treatment
Richmond Agitation Sedation Scale (RASS) score	within 120 minutes after first treatment
Percentage of Participants requiring rescue medication	during the 5-day study period
Time until rescue medication was required	during the 5-day study period
Percentage of participants experiencing a treatment-related adverse event	during the 5-day study period
Percentage of participants with clinically significant changes in vital signs	during the 5-day study period

Collaborators and Investigators

• Sponsor: INSYS Therapeutics Inc

Study record dates

Study Major Dates

• Primary Completion (Actual): June 29, 2017

Study Registration Dates

• First Submitted: May 12, 2014
• First Submitted That Met QC Criteria: May 12, 2014
• First Posted (Estimate): May 14, 2014

Study Record Updates

• Last Update Posted (Actual): July 5, 2017
• Last Update Submitted That Met QC Criteria: June 30, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Emergencies; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl; Morphine
• Other Study ID Numbers: INS-14-022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No