This is a single center randomized, double-blind, placebo-controlled study, to be conducted
at Mayo Clinic, Rochester, MN.
The objective of our research is to determine whether inhibition of the tumor necrosis
factor- alpha (TNF-a) pathway by Pentoxifylline reduces inflammatory markers in AP and
whether it is safe, beneficial and well-tolerated in patients with acute pancreatitis AP.
The study will have 2 groups of 75 patients each, all with AP, randomly assigned to either
the drug or a placebo, which looks like the drug, for a period of 3 days or until the time
they are discharged, if hospital discharge is within 7 days of admission. The levels of
markers of inflammation of C-reactive protein (C-RP), Interleukin-6 (IL-6), Interleukin-8
(IL-8) and Tumor Necrosis Factor-alpha (TNF-a) will be measured at baseline and on 5
successive days or until the time of discharge, whichever occurs earlier.
Subjects will be adult patients =18 years or older admitted to the hospital within 72 hours
of diagnosis of acute pancreatitis (AP) as defined by at least two of the following: (1)
amylase and/or lipase greater than 3x upper limit of normal, (2) characteristic
cross-sectional imaging, (3) typical abdominal pain. Enrollment into the study should take
place 24 hours of admission.
Determination of group size was based on the previous pilot study to decrease any of the
important adverse outcomes, providing for a dropout rate of 10% during the study. During
2012, 263 patients with AP were admitted to this institution, which possesses the needed
infrastructure for successful completion of clinical drug intervention trials.
Participants will be put in one of two groups (randomized) by chance (as flip of a coin).
This is done so that neither participant nor the investigator will know which group you are
Subject will be in either the treatment group (Pentoxifylline medication) or the control
group (Placebo). Placebo is a matching pill that has no medication in it.
Participant will take a pill orally (by mouth) starting from the time of admission and
enrollment. Participant will receive a total of 9 doses over the three days of
hospitalization (72 hours).
Research blood draws will be done to be measured at baseline and on 5 successive days or
until the time of discharge, whichever occurs earlier.
The research blood draws can be done at the time of standard patient care blood draws, when
a little extra (10 mL or 2 teaspoons) is drawn for the research.
Information from participant 's medical record will be gathered while hospitalized and after
dismissal. The study will continue to gather clinical follow up information up to 4 months
following hospitalization regarding the diagnosis of acute pancreatitis.
- Enrollment within 72 hours of diagnosis of 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.
- Moderate or severe congestive heart failure,
- History of seizure disorders or demyelinating disease,
- Nursing mothers,
- 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.