The primary objective is to evaluate the analgesic efficacy of TRV130 for moderate to severe acute pain in patients presenting to the emergency department (ED) with a suspected/known, unilateral, closed long bone fracture.
This study is designed to evaluate the analgesic efficacy of TRV130 for the treatment of moderate to severe acute pain associated with a long bone fracture in patients presenting to the ED. The safety and tolerability of TRV130 will also be evaluated in this open-label pilot study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Drug
Trevena, Inc.
Indianapolis, Indiana, United States
Proportion of Patients Achieving Clinical Response, Defined as Achieving a NPRS <= 3, Without Requiring Rescue Pain Medication.
Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours
Time frame: 3-hours
Time Weighted Average Change in NPRS
Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours
Time frame: From baseline to 30 minutes, to 1 hour, to 2 hours and to 3 hours
Time to First NPRS <= 3
Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours
Time frame: 3-hours
Safety Assessments
Safety assessments include adverse events, vital sign measurements, physical examination findings, and clinical laboratory assessments.
Time frame: 3-hours
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