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

Acute Pain Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02137525
• Other study ID #: INS-14-022
• Status: Withdrawn
• Phase: Phase 2
• First received: May 12, 2014
• Last updated: June 30, 2017

Study information

• Verified date: June 2017
• Source: INSYS Therapeutics Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: June 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Emergencies

Intervention

Drug:
• Morphine 6 mg
Intravenous infusion - delivering morphine 6 mg
• Fentanyl 100 µg
Fentanyl sublingual spray - single unit delivering 100 µg fentanyl
• Fentanyl 200 µg
Fentanyl sublingual spray - single unit delivering 200 µg fentanyl
• Fentanyl 400 µg
Fentanyl sublingual spray - single unit delivering 400 µg fentanyl
• Placebo Sublingual Spray
Matching sublingual spray - single unit delivering 0 µg fentanyl
• Intravenous Placebo
Matching intravenous infusion - delivering 0 mg morphine

Locations

Country	Name	City	State
United States	University of Virginia Health System	Charlottesville	Virginia
United States	University of Cincinnati	Cincinnati	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Wayne State University School of Medicine	Detroit	Michigan
United States	Duke University School of Medicine	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Vanderbilt University	Nashville	Tennessee
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Maricopa Medical Center	Phoenix	Arizona
United States	Washington University	Saint Louis	Missouri
United States	Stony Brook University HSC	Stony Brook	New York
United States	Olive View-UCLA Medical Center	Sylmar	California

Sponsors (1)

Lead Sponsor	Collaborator
INSYS Therapeutics Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants requiring additional doses of randomized pain medication		at 30 minutes after initial treatment
Secondary	Percentage of participants requiring additional doses of randomized pain medication at secondary time points		within 120 minutes after initial treatment
Secondary	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
Secondary	Number of Investigational Product (IP) administrations		within 120 minutes after initial treatment
Secondary	Time to onset of pain relief (in minutes) using the stopwatch method		within 120 minutes after first treatment
Secondary	Richmond Agitation Sedation Scale (RASS) score		within 120 minutes after first treatment
Secondary	Percentage of Participants requiring rescue medication		during the 5-day study period
Secondary	Time until rescue medication was required		during the 5-day study period
Secondary	Percentage of participants experiencing a treatment-related adverse event		during the 5-day study period
Secondary	Percentage of participants with clinically significant changes in vital signs		during the 5-day study period