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A Open-label Study to Evaluate the Safety of TRV130 in Patients With Acute Pain (ATHENA-1)

Primary Purpose

Acute Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
TRV130
Sponsored by
Trevena Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Recruiting
  • Recruiting
  • Recruiting
  • Recruiting
  • Recruiting
  • Recruiting
  • Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TRV130

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Patients That Experienced a Treatment-emergent Adverse Event

Secondary Outcome Measures

Full Information

First Posted
January 13, 2016
Last Updated
September 23, 2020
Sponsor
Trevena Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02656875
Brief Title
A Open-label Study to Evaluate the Safety of TRV130 in Patients With Acute Pain
Acronym
ATHENA-1
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trevena Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
768 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TRV130
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
TRV130
Other Intervention Name(s)
oliceridine
Primary Outcome Measure Information:
Title
Number of Patients That Experienced a Treatment-emergent Adverse Event
Time Frame
From first dose through 3 days after last dose, approximately 4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck Skobieranda, MD
Organizational Affiliation
Trevena Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Recruiting
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Recruiting
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Recruiting
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Recruiting
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Recruiting
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Recruiting
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Recruiting
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31814753
Citation
Bergese SD, Brzezinski M, Hammer GB, Beard TL, Pan PH, Mace SE, Berkowitz RD, Cochrane K, Wase L, Minkowitz HS, Habib AS. ATHENA: A Phase 3, Open-Label Study Of The Safety And Effectiveness Of Oliceridine (TRV130), A G-Protein Selective Agonist At The micro-Opioid Receptor, In Patients With Moderate To Severe Acute Pain Requiring Parenteral Opioid Therapy. J Pain Res. 2019 Nov 14;12:3113-3126. doi: 10.2147/JPR.S217563. eCollection 2019.
Results Reference
derived

Learn more about this trial

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

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