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

Phase 2

Withdrawn

• Conditions: Acute Pain
• Interventions: Drug: Morphine 6 mg; Drug: Fentanyl 100 µg; Drug: Fentanyl 200 µg; Drug: Fentanyl 400 µg; Drug: Placebo Sublingual Spray; Drug: Intravenous Placebo

• Registration Number: NCT02137525
• Lead Sponsor: INSYS Therapeutics Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-12
• Study First Submitted QC: 2014-05-12
• Study First Posted: 2014-05-14
• Status Verified: 2017-06
• Primary Completion: 2017-06-29
• Last Update Submitted: 2017-06-30
• Last Update Posted: 2017-07-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Morphine 6 mg	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
Morphine 6 mg	Placebo Sublingual Spray	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
Fentanyl 100 µg	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
Fentanyl 100 µg	Intravenous Placebo	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
Fentanyl 200 µg	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
Fentanyl 200 µg	Intravenous Placebo	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
Fentanyl 400 µg	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
Fentanyl 400 µg	Intravenous Placebo	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

Primary Outcome Measures

Name	Time	Method
Percentage of participants requiring additional doses of randomized pain medication	at 30 minutes after initial treatment

Secondary Outcome Measures

Name	Time	Method
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 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 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

Trial Locations

Locations (15)

Wayne State University School of Medicine; 🇺🇸 Detroit, Michigan, United States

Kansas University Medical Center; 🇺🇸 Kansas City, Kansas, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Maricopa Medical Center; 🇺🇸 Phoenix, Arizona, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

Stony Brook University HSC; 🇺🇸 Stony Brook, New York, United States

Duke University School of Medicine; 🇺🇸 Durham, North Carolina, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Pennsylvania Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States

Olive View-UCLA Medical Center; 🇺🇸 Sylmar, California, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States