Pentoxifylline Treatment in Acute Pancreatitis (AP) (AP)
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|ClinicalTrials.gov Identifier: NCT02487225|
Recruitment Status : Completed
First Posted : July 1, 2015
Results First Posted : January 23, 2019
Last Update Posted : January 23, 2019
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
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
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.
A harmless pill that has no therapeutic effect, used as a control in testing of investigational drug
- 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
- 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
- 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
- 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
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
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Santhi Swaroop Vege, MD||Mayo Clinic|