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

• ClinicalTrials.gov Identifier: NCT02656875
• Recruitment Status: Completed
• First Posted: January 15, 2016
• Results First Posted: September 24, 2020
• Last Update Posted: September 24, 2020
• Sponsor: Trevena Inc.
• Information provided by (Responsible Party): Trevena Inc.

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.

Condition or disease	Intervention/treatment	Phase
Acute Pain	Drug: TRV130	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 768 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: December 2015
• Actual Primary Completion Date: May 2017
• Actual Study Completion Date: August 2017

Arms and Interventions

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 Name: oliceridine

Outcome Measures

Primary Outcome Measures :

1. Number of Patients That Experienced a Treatment-emergent Adverse Event [ Time Frame: From first dose through 3 days after last dose, approximately 4 days ]

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, Alabama

Recruiting

Mobile, Alabama, United States, 36608

United States, California

Recruiting

Pasadena, California, United States, 91105

United States, Florida

Recruiting

Miami, Florida, United States, 33155

United States, Louisiana

Recruiting

Shreveport, Louisiana, United States, 71101

United States, Mississippi

Recruiting

Jackson, Mississippi, United States, 39202

United States, New York

Staten Island, New York, United States, 10305

United States, Pennsylvania

Recruiting

State College, Pennsylvania, United States, 16801

United States, Texas

Houston, Texas, United States, 77004

Houston, Texas, United States, 77027

United States, Utah

Recruiting

Murray, Utah, United States, 84123

Sponsors and Collaborators

Trevena Inc.

Investigators

• Study Chair: Franck Skobieranda, MD; Trevena Inc.

  Study Documents (Full-Text)

Documents provided by Trevena Inc.:

Study Protocol  [PDF] September 14, 2016

Statistical Analysis Plan  [PDF] December 20, 2016

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Trevena Inc.
• ClinicalTrials.gov Identifier: NCT02656875
• Other Study ID Numbers: CP130-3003
• First Posted: January 15, 2016
• Results First Posted: September 24, 2020
• Last Update Posted: September 24, 2020
• Last Verified: September 2020

Additional relevant MeSH terms:

Acute Pain; Pain; Neurologic Manifestations