A Open-label Study to Evaluate the Safety of TRV130 in Patients With Acute Pain (ATHENA-1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02656875|
Recruitment Status : Completed
First Posted : January 15, 2016
Results First Posted : September 24, 2020
Last Update Posted : September 24, 2020
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Acute Pain||Drug: TRV130||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||768 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
Other Name: oliceridine
- Number of Patients That Experienced a Treatment-emergent Adverse Event [ Time Frame: From first dose through 3 days after last dose, approximately 4 days ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
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
|United States, Alabama|
|Mobile, Alabama, United States, 36608|
|United States, California|
|Pasadena, California, United States, 91105|
|United States, Florida|
|Miami, Florida, United States, 33155|
|United States, Louisiana|
|Shreveport, Louisiana, United States, 71101|
|United States, Mississippi|
|Jackson, Mississippi, United States, 39202|
|United States, New York|
|Staten Island, New York, United States, 10305|
|United States, Pennsylvania|
|State College, Pennsylvania, United States, 16801|
|United States, Texas|
|Houston, Texas, United States, 77004|
|Houston, Texas, United States, 77027|
|United States, Utah|
|Murray, Utah, United States, 84123|
|Study Chair:||Franck Skobieranda, MD||Trevena Inc.|
Documents provided by Trevena Inc.:
|Responsible Party:||Trevena Inc.|
|Other Study ID Numbers:||
|First Posted:||January 15, 2016 Key Record Dates|
|Results First Posted:||September 24, 2020|
|Last Update Posted:||September 24, 2020|
|Last Verified:||September 2020|