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

Primary Purpose

Acute Pain

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Morphine 6 mg
Fentanyl 100 µg
Fentanyl 200 µg
Fentanyl 400 µg
Placebo Sublingual Spray
Intravenous Placebo
Sponsored by
INSYS Therapeutics Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maricopa Medical Center
  • Olive View-UCLA Medical Center
  • Kansas University Medical Center
  • Henry Ford Hospital
  • Wayne State University School of Medicine
  • Hennepin County Medical Center
  • Washington University
  • Stony Brook University HSC
  • Duke University School of Medicine
  • University of Cincinnati
  • Pennsylvania Hospital
  • Thomas Jefferson University Hospital
  • Vanderbilt University
  • Baylor College of Medicine
  • University of Virginia Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Morphine 6 mg

Fentanyl 100 µg

Fentanyl 200 µg

Fentanyl 400 µg

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Percentage of participants requiring additional doses of randomized pain medication

Secondary Outcome Measures

Percentage of participants requiring additional doses of randomized pain medication at secondary time points
Visual analogue scale (VAS) Summed Pain Intensity Difference (SPID) calculated as Area under the Curve (AUC) every 30 minutes
Number of Investigational Product (IP) administrations
Time to onset of pain relief (in minutes) using the stopwatch method
Richmond Agitation Sedation Scale (RASS) score
Percentage of Participants requiring rescue medication
Time until rescue medication was required
Percentage of participants experiencing a treatment-related adverse event
Percentage of participants with clinically significant changes in vital signs

Full Information

First Posted
May 12, 2014
Last Updated
June 30, 2017
Sponsor
INSYS Therapeutics Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02137525
Brief Title
Study to Explore Effectiveness of Sublingual Fentanyl Spray in Emergency Department Patients With Acute Pain
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Study was never initiated
Study Start Date
undefined (undefined)
Primary Completion Date
June 29, 2017 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
INSYS Therapeutics Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Morphine 6 mg
Arm Type
Active Comparator
Arm Description
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
Arm Title
Fentanyl 100 µg
Arm Type
Experimental
Arm Description
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
Arm Title
Fentanyl 200 µg
Arm Type
Experimental
Arm Description
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
Arm Title
Fentanyl 400 µg
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Morphine 6 mg
Other Intervention Name(s)
IVM 6 mg, Standard of Care
Intervention Description
Intravenous infusion - delivering morphine 6 mg
Intervention Type
Drug
Intervention Name(s)
Fentanyl 100 µg
Other Intervention Name(s)
FSS 100 µg, SUBSYS®
Intervention Description
Fentanyl sublingual spray - single unit delivering 100 µg fentanyl
Intervention Type
Drug
Intervention Name(s)
Fentanyl 200 µg
Other Intervention Name(s)
FSS 200 µg, SUBSYS®
Intervention Description
Fentanyl sublingual spray - single unit delivering 200 µg fentanyl
Intervention Type
Drug
Intervention Name(s)
Fentanyl 400 µg
Other Intervention Name(s)
FSS 400 µg, SUBSYS®
Intervention Description
Fentanyl sublingual spray - single unit delivering 400 µg fentanyl
Intervention Type
Drug
Intervention Name(s)
Placebo Sublingual Spray
Other Intervention Name(s)
PSS
Intervention Description
Matching sublingual spray - single unit delivering 0 µg fentanyl
Intervention Type
Drug
Intervention Name(s)
Intravenous Placebo
Other Intervention Name(s)
IVP
Intervention Description
Matching intravenous infusion - delivering 0 mg morphine
Primary Outcome Measure Information:
Title
Percentage of participants requiring additional doses of randomized pain medication
Time Frame
at 30 minutes after initial treatment
Secondary Outcome Measure Information:
Title
Percentage of participants requiring additional doses of randomized pain medication at secondary time points
Time Frame
within 120 minutes after initial treatment
Title
Visual analogue scale (VAS) Summed Pain Intensity Difference (SPID) calculated as Area under the Curve (AUC) every 30 minutes
Time Frame
from baseline through 120 minutes after the initial dose of investigational product
Title
Number of Investigational Product (IP) administrations
Time Frame
within 120 minutes after initial treatment
Title
Time to onset of pain relief (in minutes) using the stopwatch method
Time Frame
within 120 minutes after first treatment
Title
Richmond Agitation Sedation Scale (RASS) score
Time Frame
within 120 minutes after first treatment
Title
Percentage of Participants requiring rescue medication
Time Frame
during the 5-day study period
Title
Time until rescue medication was required
Time Frame
during the 5-day study period
Title
Percentage of participants experiencing a treatment-related adverse event
Time Frame
during the 5-day study period
Title
Percentage of participants with clinically significant changes in vital signs
Time Frame
during the 5-day study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni DeCastro
Organizational Affiliation
INSYS Therapeutics Inc
Official's Role
Study Director
Facility Information:
Facility Name
Maricopa Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
Olive View-UCLA Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48021
Country
United States
Facility Name
Wayne State University School of Medicine
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Stony Brook University HSC
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Duke University School of Medicine
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

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

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