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

NCT ID: NCT02656875

Last Updated: 2020-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 768 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-08-31

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.

Conditions

Acute Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

TRV130

Intervention Type: DRUG

Interventions

TRV130

Intervention Type: DRUG

Other Intervention Names

oliceridine

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Trevena Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Franck Skobieranda, MD

Role: STUDY_CHAIR

Trevena Inc.

Locations

Recruiting

Mobile, Alabama, United States

Recruiting

Pasadena, California, United States

Recruiting

Miami, Florida, United States

Recruiting

Shreveport, Louisiana, United States

Recruiting

Jackson, Mississippi, United States

Staten Island, New York, United States

Recruiting

State College, Pennsylvania, United States

Houston, Texas, United States

Houston, Texas, United States

Recruiting

Murray, Utah, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31814753 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CP130-3003

Identifier Type: -

Identifier Source: org_study_id