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

Acute Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656875
• Other study ID #: CP130-3003
• Status: Completed
• Phase: Phase 3
• Start date: December 2015
• Est. completion date: August 2017

Study information

• Verified date: September 2020
• Source: Trevena Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 768
• Est. completion date: August 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• TRV130

Locations

Country	Name	City	State
United States	Recruiting	Jackson	Mississippi
United States	Recruiting	Miami	Florida
United States	Recruiting	Mobile	Alabama
United States	Recruiting	Murray	Utah
United States	Recruiting	Pasadena	California
United States	Recruiting	Shreveport	Louisiana
United States	Recruiting	State College	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Trevena Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients That Experienced a Treatment-emergent Adverse Event		From first dose through 3 days after last dose, approximately 4 days