A Open-label Study to Evaluate the Safety of TRV130 in Patients With Acute Pain

Study Overview
=================
Brief Summary
-----------------
Patients with moderate to severe pain caused by medical conditions or surgery, who require IV opioid therapy may be enrolled in this open label safety study. Patients will be treated with TRV130 by IV bolus, PCA (patient-controlled analgesia) administration, or both, as determined by the investigator, for a duration not to exceed 14 days.

Detailed Description
-----------------
The duration of treatment for each patient will be determined by the clinical need for parenteral opioid therapy. Eligible patients with moderate to severe pain caused by medical conditions or surgery, who require IV opioid therapy may be enrolled in this open label safety study. Patients will be treated with TRV130 by IV bolus, PCA administration, or both, as determined by the investigator, for a duration not to exceed 14 days. The duration of treatment for each patient will be determined by the clinical need for parenteral opioid therapy. A follow-up assessment will take place 2-3 days after the completion of the treatment phase.

Official Title
-----------------
A Phase 3, Open-label Study to Evaluate the Safety of TRV130 in Patients With Acute Pain for Which Parenteral Opioid Therapy is Warranted

Conditions
-----------------
Acute Pain

Intervention / Treatment
-----------------
* Drug: TRV130


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria include: Moderate to severe acute pain for which parenteral opioid therapy is warranted Able to understand and comply with the procedures and study requirements, and to provide written informed consent before any study procedure. Exclusion Criteria include: Clinically significant medical, surgical, postsurgical, psychiatric or substance abuse condition or history of such condition that would confound the interpretation of safety, tolerability, or efficacy data in the study. Hemodynamic instability or respiratory insufficiency. Advanced cancer in palliative or end-of-life care. Another current painful condition (other than acute pain for which parenteral opioid therapy is warranted) that would confound the interpretation of safety, tolerability, or efficacy data in the study. Clinically significant, immune-mediated hypersensitivity reaction to opioids.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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>For clinician-administered bolus dosing, TRV130 initial dose is administered and supplemental dosing is available, if clinically indicated. Subsequent doses may be administered every 1 to 3 hours as needed. For PCA dosing, the TRV130 regimen consists of a loading dose, a demand dose, and a lockout interval. | Drug: TRV130<br> <br> * Other names: oliceridine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients That Experienced a Treatment-emergent Adverse Event |  | From first dose through 3 days after last dose, approximately 4 days |