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Completed

NCT Number: NCT02487225

Pentoxifylline Treatment in Acute Pancreatitis (AP)

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

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Key information

Conditions

Acute Pancreatitis (AP) Alcohol-Induced Disorders Alcohol-Related Disorders Alcoholic Pancreatitis Cancer Acute Pancreatitis Chemically-Induced Disorders Digestive System Diseases Gallstone Pancreatitis Hypertriglyceridemia Acute Pancreatitis Idiopathic (Unknown) Acute Pancreatitis Medication Induced Acute Pancreatitis Miscellaneous (i.e. Acute on Chronic Pancreatitis) Pancreatic Diseases Pancreatitis Pancreatitis, Alcoholic Substance-Related Disorders Trauma Acute Pancreatitis

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

Participants were randomized to either the treatment group (Pentoxifylline medication) or the control group (Placebo).

Participant took a pill orally, starting from the time of admission. Participants received a total of 9 doses over the three days of hospitalization (72 hours).

Research blood draws were done at baseline and on 5 successive days or until the time of discharge, whichever occured earlier. The study gathered clinical follow up information up to 4 months following hospitalization regarding the diagnosis of acute pancreatitis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Enrollment within 72 hours of diagnosis of acute pancreatitis (AP)
  • Ability to give informed consent or a Legal Adult Representative (LAR) able to give informed consent for subject when needed as defined buy LAR use guidelines.
  • Adult subjects of age ≥18 years.

Exclusion criteria

  • Moderate or severe congestive heart failure
  • History of seizure disorders or demyelinating disease
  • Nursing mothers
  • Pregnancy
  • History of prior tuberculosis or risk factors for tuberculosis
  • Evidence of non- corticosteroid immunosuppression (such as malignancy, chronic renal failure, chemotherapy within 60 days, and HIV)
  • Evidence of active hemorrhage
  • Paralytic ileus with severe nausea and vomiting

Treatment and study plan

Pentoxifylline

Drug

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

Other names: Trental, Pentox, Pentoxil, Flexital

Placebo

Drug

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

Primary outcomes

  1. Change in C-reactive Protein (C-RP) From Admission Baseline at One Week.

    Time frame: Admission (baseline), day 5

    C-reactive protein is a substance produced by the liver in response to inflammation. Normal C-RP levels are below 3.0 mg/L.Units: mg/L

  2. Change in Tumor Necrosis Factor-alpha (TNF-a) Levels From Admission Baseline at One Week.

    Time frame: Admission (baseline), day 5

    Tumor Necrosis Factor Alpha is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. TNF is important to the body because it helps regulate the response of the immune system to a foreign object, especially to the present cancerous tumor. It promotes inflammation, produces other cells used in the inflammatory response, and can help cells heal. The normal range is 5 to 27.2 pg/ml.Units: pg/ml

  3. Change in Interleukin-6 (IL-6) Levels From Admission Baseline at One Week.

    Time frame: Admission (baseline), day 5

    Interleukin-6 (IL-6) may be used to help evaluate a person who has a condition associated with inflammation, such as lupus or rheumatoid arthritis, or with infection, such as sepsis. It may also be used in the evaluation of diabetes or cardiovascular disease. IL-6 is a cytokine, a protein produced by immune cells that acts on other cells to help regulate and/or promote an immune response. It also stimulates the production of acute phase reactants, proteins that increase in the blood with conditions that cause inflammation or tissue injury. Circulating IL-6 can be found in the blood of normal individuals in the 1 pg/mL range, with slight elevations during the menstrual cycle, modest elevations in certain cancers (melanoma) (10 pg/mL), and large elevations after surgery (30-430 pg/mL).Units: pg/ml

  4. Change in Interleukin-8 (IL-8) Levels From Admission Baseline at One Week.

    Time frame: Admission (baseline), day 5

    IL-8 is a chemotactic factor that attracts neutrophils, basophils, and T-cells, but not monocytes. It is also involved in neutrophil activation. It is released from several cell types in response to an inflammatory stimulus. Units: pg/mL

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

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

Registry information

Official study title

Pentoxifylline Treatment in Acute Pancreatitis: A Double-Blind Placebo - Controlled Randomized Trial

Acronym: AP

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 1, 2015
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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