Pentoxifylline Treatment in Acute Pancreatitis (AP)

Mayo Clinic

Status and phase: Completed; Phase 3

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

Treatments: Drug: Pentoxifylline; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02487225

1R21DK101889-01A1 (U.S. NIH Grant/Contract)

15-001710

Details and patient eligibility

About

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

Full 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.

Enrollment: 83 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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83 participants in 2 patient groups, including a placebo group

Pentoxifylline

Experimental group

Description:

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.

Treatment:

Drug: Pentoxifylline

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo