NCT02656875

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
768

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 13, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

September 24, 2020

Completed
Last Updated

September 24, 2020

Status Verified

September 1, 2020

Enrollment Period

1.4 years

First QC Date

January 13, 2016

Results QC Date

August 24, 2020

Last Update Submit

September 23, 2020

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

  • Number of Patients That Experienced a Treatment-emergent Adverse Event

    From first dose through 3 days after last dose, approximately 4 days

Study Arms (1)

TRV130

EXPERIMENTAL

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

Interventions

TRV130DRUG
Also known as: oliceridine
TRV130

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Recruiting

Mobile, Alabama, 36608, United States

Location

Recruiting

Pasadena, California, 91105, United States

Location

Recruiting

Miami, Florida, 33155, United States

Location

Recruiting

Shreveport, Louisiana, 71101, United States

Location

Recruiting

Jackson, Mississippi, 39202, United States

Location

Unknown Facility

Staten Island, New York, 10305, United States

Location

Recruiting

State College, Pennsylvania, 16801, United States

Location

Unknown Facility

Houston, Texas, 77004, United States

Location

Unknown Facility

Houston, Texas, 77027, United States

Location

Recruiting

Murray, Utah, 84123, United States

Location

Related Publications (1)

  • 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.

    PMID: 31814753DERIVED

MeSH Terms

Conditions

Acute Pain

Interventions

((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Kelly Arscott
Organization
Trevena, Inc.
karscott@trevena.com
6103548840

Study Officials

  • Franck Skobieranda, MD

    Trevena Inc.

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2016

First Posted

January 15, 2016

Study Start

December 1, 2015

Primary Completion

May 1, 2017

Study Completion

August 1, 2017

Last Updated

September 24, 2020

Results First Posted

September 24, 2020

Record last verified: 2020-09

Locations

US(10)