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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Drug: TRV130

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.

• Study Type: Interventional
• Enrollment (Actual): 768
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Recruiting
  • California
    • Pasadena, California, United States, 91105
      • Recruiting
  • Florida
    • Miami, Florida, United States, 33155
      • Recruiting
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Recruiting
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Recruiting
  • New York
    • Staten Island, New York, United States, 10305
  • Pennsylvania
    • State College, Pennsylvania, United States, 16801
      • Recruiting
  • Texas
    • Houston, Texas, United States, 77004
    • Houston, Texas, United States, 77027
  • Utah
    • Murray, Utah, United States, 84123
      • Recruiting

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRV130; 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; Other Names: oliceridine

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Trevena Inc.
• Investigators: Study Chair: Franck Skobieranda, MD, Trevena Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: January 13, 2016
• First Submitted That Met QC Criteria: January 14, 2016
• First Posted (Estimate): January 15, 2016

Study Record Updates

• Last Update Posted (Actual): September 24, 2020
• Last Update Submitted That Met QC Criteria: September 23, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: CP130-3003