Pentoxifylline Treatment in Acute Pancreatitis (AP)

Phase 3

Completed

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

Interventions: Drug: Placebo
Drug: Pentoxifylline

Registration Number: NCT02487225

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 83

Inclusion Criteria

Not provided

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Pentoxifylline	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.

Primary Outcome Measures

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