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Pentoxifylline Treatment in Acute Pancreatitis (AP) (AP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02487225
Recruitment Status : Completed
First Posted : July 1, 2015
Results First Posted : January 23, 2019
Last Update Posted : January 23, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Santhi Swaroop Vege, M.D., Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
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) Drug: Pentoxifylline Drug: Placebo Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pentoxifylline Treatment in Acute Pancreatitis: A Double-Blind Placebo - Controlled Randomized Trial
Study Start Date : May 2015
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Experimental: Pentoxifylline
Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects to receive up to a maximum of 9 doses.
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
Other Names:
  • Trental
  • Pentox
  • Pentoxil
  • Flexital

Placebo Comparator: Placebo
Placebo 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects to receive up to a maximum of 9 doses.
Drug: Placebo
A harmless pill that has no therapeutic effect, used as a control in testing of investigational drug




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02487225


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Santhi Swaroop Vege, MD Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Santhi Swaroop Vege, M.D., Mayo Clinic:

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Responsible Party: Santhi Swaroop Vege, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02487225     History of Changes
Other Study ID Numbers: 15-001710
1R21DK101889-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 1, 2015    Key Record Dates
Results First Posted: January 23, 2019
Last Update Posted: January 23, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Santhi Swaroop Vege, M.D., Mayo Clinic:
Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) pancreatitis
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Gallstones
Pancreatitis, Alcoholic
Hypertriglyceridemia
Pancreatic Diseases
Digestive System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Cholelithiasis
Biliary Tract Diseases
Cholecystolithiasis
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Pentoxifylline
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents