Clinical Trial TitleA phase 3, open-label study to evaluate the safety of TRV130 in patients with acute pain for which parenteral opioid therapy is warranted.
Clinical Trial Protocol Description:
The purpose of this study is test the safety and administration of TRV130. Most doctors use powerful pain-relieving medicines called opioids (narcotics) to treat moderate or severe acute pain after an operation or for painful illnesses. Morphine is an example. Such medicines often need to be given to the patient through a needle inserted into a vein, that is, intravenously (IV).
TRV130 is a new kind of opioid medication that may have fewer side effects and/or work more effectively than morphine or other opioids. In previous studies in patients who had an operation, TRV130 had fewer side effects than morphine while giving similar pain relief and it reduced pain more quickly.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Be at least 18 years of age at screening.
- Have moderate to severe acute pain for which parenteral opioid therapy is warranted, defined as NPRS pain intensity of >=4 during the pre-dose period.
- Be able to understand and comply with the procedures and study requirements, and to provide written informed consent before any study procedure.
You will be excluded from the study if any of the following criteria apply to you:
- Have 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.
- Have hemodynamic instability or respiratory insufficiency.
- Have advanced cancer in palliative or end-of-life care.
- Have concurrent use of chemotherapeutic or biologic agents for the treatment of cancer.
This is a partial list of inclusion and exclusion criteria.