A Pilot Study of TRV130 for the Treatment of Fracture Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase 2, Open-label Pilot Study of TRV130 for the Treatment of Moderate to Severe Acute Pain Associated With Long Bone Fracture

Conditions
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Pain

Intervention / Treatment
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* Drug: TRV130


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 years, inclusive Has a suspected/known, unilateral, closed fracture of either: radius, ulna (or both) OR tibia, fibula (or both) BUT not fractures in more than 1 extremity Able to understand and comply with study procedures and requirements, and provide written informed consent Exclusion Criteria: Significant concomitant head, chest, or abdominal trauma Multiple extremity trauma Open fracture Clinically significant medical condition or history of such condition that may place the patient at an unacceptable risk in the trial, may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRV130<br>Drug: TRV130 | Drug: TRV130<br>* Drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3-hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Weighted Average Change in NPRS | Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours | 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 | 3-hours | 
| Safety Assessments | Safety assessments include adverse events, vital sign measurements, physical examination findings, and clinical laboratory assessments. | 3-hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Long bone, Fracture