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Pentoxifylline Treatment in Acute Pancreatitis (AP)

NCT02487225 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2019-01-23

Study results available
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Summary

The purpose of this study was to determine the effects (good and bad) of giving a drug called pentoxifylline to patients with acute pancreatitis.

Conditions

  • Acute Pancreatitis (AP)
  • Gallstone Pancreatitis
  • Alcoholic Pancreatitis
  • Trauma Acute Pancreatitis
  • Hypertriglyceridemia Acute Pancreatitis
  • Idiopathic (Unknown) Acute Pancreatitis
  • Medication Induced Acute Pancreatitis
  • Cancer Acute Pancreatitis
  • Miscellaneous (i.e. Acute on Chronic Pancreatitis)

Interventions

DRUG

Pentoxifylline

Pentoxifylline is a competitive nonselective phosphodiesterase inhibitor which raises intracellular cyclic adenosine monophosphate (cAMP), activates protein kinase A (PKA), inhibits Tumor Necrosis Factor (TNF) and leukotriene synthesis, and reduces inflammation and innate immunity. In addition, pentoxifylline improves red blood cell deformability (known as a haemorrheologic effect), reduces blood viscosity and decreases the potential for platelet aggregation and thrombus formation.Pentoxifylline is also an antagonist at adenosine 2 receptors

DRUG

Placebo

A harmless pill that has no therapeutic effect, used as a control in testing of investigational drug

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Santhi Swaroop Vege, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-04-30
Completion
2017-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02487225 on ClinicalTrials.gov