Study of oliceridine in patients with acute pain for which parenteral opioid therapy is warranted

Phase: III

Sponsor:  Trevena, Inc.

Contact:  Mollie Ball, 541-706-6594 or mball@bmctotalcare.com

Purpose:  To evaluate the safety and tolerability of oliceridine in patients with moderate to severe acute pain for which parenteral opioid therapy is warranted.

Inclusion Criteria:

  • Age >18 years at screening
  • Moderate to severe acute pain for which parenteral opioid therapy is warranted, defined as NPRS pain intensity of >4 during the pre-dose period
  • Able to understand and comply with the procedures and study requirements, and to provide written informed consent before any study procedure
  • If it is anticipated that the patient will be treated with oliceridine in the ED with subsequent discharge or transfer to another facility, that the patient will remain under the care of the investigator for at least three hours after the last dose of oliceridine

Exclusion Criteria:

  • Participated in another oliceridine clinical study
  • 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; or requires a tracheostomy or mechanically assisted ventilation
  • Advanced cancer in palliative or end-of-life care
  • Concurrent use of chemotherapeutic or biologic agents for the treatment of cancer
  • 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
  • Pregnancy, breastfeeding, or positive urine or serum pregnancy test at screening
  • Hepatic impairment (total bilirubin >2 x upper limit of normal [ULN], aspartate aminotransferase [AST] > =1.5 x ULN) or renal impairment (estimated Glomerular Filtration Rate [eGFR] <=29 nL/min/1.73 m² based on the Modification of Diet in Renal Disease [MDRD] equation), known or obtained at screening
  • History of human immunodeficiency virus, hepatitis B or hepatitis C
  • Clinically significant abnormal clinical laboratory values, known or obtained at screening
  • Clinically significant abnormal ECG
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