Clinical trial NCT02137525: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Acute Pain
Lead sponsor: INSYS Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2014-05-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of participants requiring additional doses of randomized pain medication
timeFrame: at 30 minutes after initial treatment
Secondary outcomes:
measure: Percentage of participants requiring additional doses of randomized pain medication at secondary time points
timeFrame: within 120 minutes after initial treatment
measure: Visual analogue scale (VAS) Summed Pain Intensity Difference (SPID) calculated as Area under the Curve (AUC) every 30 minutes
timeFrame: from baseline through 120 minutes after the initial dose of investigational product
measure: Number of Investigational Product (IP) administrations
timeFrame: within 120 minutes after initial treatment
measure: Time to onset of pain relief (in minutes) using the stopwatch method
timeFrame: within 120 minutes after first treatment
measure: Richmond Agitation Sedation Scale (RASS) score
timeFrame: within 120 minutes after first treatment
measure: Percentage of Participants requiring rescue medication
timeFrame: during the 5-day study period
measure: Time until rescue medication was required
timeFrame: during the 5-day study period
measure: Percentage of participants experiencing a treatment-related adverse event
timeFrame: during the 5-day study period
measure: Percentage of participants with clinically significant changes in vital signs
timeFrame: during the 5-day study period
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Maricopa Medical Center
state: Arizona
city: Sylmar
country: United States
facility: Olive View-UCLA Medical Center
state: California
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: Wayne State University School of Medicine
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Stony Brook
country: United States
facility: Stony Brook University HSC
state: New York
city: Durham
country: United States
facility: Duke University School of Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: INSYS Therapeutics Inc
name: Giovanni DeCastro
role: STUDY_DIRECTOR
References: