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

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ClinicalTrials.gov Identifier: NCT02656875
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Trevena Inc.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 768 participants
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

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




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: From first dose through 3 days after end of treatment phase ]


Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656875


Locations
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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
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Study Chair: Franck Skobieranda, MD Trevena Inc.

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Responsible Party: Trevena Inc.
ClinicalTrials.gov Identifier: NCT02656875     History of Changes
Other Study ID Numbers: CP130-3003
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2016

Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms