Pentoxifylline Treatment of Acute Pancreatitis

Mayo Clinic

Status and phase: Completed; Early Phase 1

Conditions: Acute Pancreatitis

Treatments: Drug: Placebo; Drug: Pentoxifylline

Study type: Interventional

Funder types: Other

Identifiers

NCT01292005

08-006648

Details and patient eligibility

About

The purpose of this study is to determine the effects (good and bad) of giving a drug called pentoxifylline to patients with acute pancreatitis, to see if it can improve blood tests associated with inflammation (tissue damage). Pentoxifylline is approved by the US Food and Drug Administration (FDA) for treatment of circulation problems, but its use in this study is investigational, which means that the FDA has not approved it for the treatment of pancreatitis. However, the FDA has allowed the use of pentoxifylline in this research study.

Full description

Subjects will be put in one of two groups by chance (as in the flip of a coin). This is done so that neither you nor the investigator will know which group you are in.

You will be put into either the treatment group or the control group.

• The treatment group will receive a drug called pentoxifylline
• The control group will receive a placebo (matching pill that has no medication in it) You will take the pills by mouth starting from the time of admission. You will receive a total of 9 doses over the first three days of your hospitalization (72 hours).

When subject have standard patient care blood draws, additional blood will be taken to do the research tests. The additional blood tests will be done every day for up to 5 days, after the administration of study drug or till the time of discharge whichever occurs earlier. The additional tests will require about 2 teaspoons (10 ml) of blood per day; the maximum amount of extra blood taken would be less than 3 tablespoons (40.0 ml). Information from your medical record will be gathered while you are hospitalized and after your discharge. The study will continue to gather clinical follow up information up to four months.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Predicted Severe Acute Pancreatitis
2. Enrollment within 72 hours of diagnosis
3. Ability to give informed consent
4. Age >17 years

Exclusion criteria

1. Moderate or severe congestive heart failure
2. History of seizure disorder or demyelinating disease
3. Nursing mothers
4. Pregnancy
5. History of prior tuberculosis or risk factors for tuberculosis
6. Evidence of immunosuppression (malignancy, chronic renal failure, chemotherapy within 60 days, ongoing steroid treatment*, and HIV)- (*the exception of prednisone use will be allowed to participate).
7. Evidence of chronic pancreatitis from history and examination (however, "acute on chronic pancreatitis" diagnosis is allowed)
8. Evidence of active or pending hemorrhage.
9. Paralytic ileus with vomiting

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 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 received up to a maximum of 9 doses.

Treatment:

Drug: Pentoxifylline

Placebo

Placebo Comparator group

Description:

Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.

Treatment:

Drug: Placebo