Auxora in Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome

What is the Purpose of this Study?

The purpose of this study is to determine whether an experimental drug called Auxora is safe to use in people who have acute pancreatitis with accompanying systemic inflammatory response syndrome (SIRS). Acute pancreatitis with SIRS is a condition in which the pancreas has suddenly become swollen and is causing serious complications in other parts of the body. Researchers aim to identify the best dose of the drug to give to patients and will test 3 doses of Auxora against placebo (inactive substance). Participants will be randomly assigned to receive Auxora plus standard care or standard care and placebo; their chance of receiving a dose is 75% (for every 1 who receives placebo, 3 receive a dose of Auxora).


Eligibility

  • All of the following must be met for a patient to be randomized into the study:
  • The diagnosis of acute pancreatitis has been established by the presence of abdominal pain consistent with acute pancreatitis together with at least 1 of the following 2 criteria:
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

A Randomized, Double-Blind, Placebo Controlled Dose-Ranging Study of Auxora in Patients with Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome

Study Details
Disease Type/Condition

Other

Principal Investigator

Pandol, Stephen

Age Group

Adult

Phase

II

IRB Number

STUDY00002230

ClinicalTrials.gov ID

NCT04681066

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Pandol, Stephen

Age Group

Adult

Phase

II

IRB Number

CM4620-203

ClinicalTrials.gov ID

NCT04681066

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org