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Completed

NCT Number: NCT01292005

Pentoxifylline Treatment of Acute Pancreatitis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Predicted Severe Acute Pancreatitis
  • Enrollment within 72 hours of diagnosis
  • Ability to give informed consent
  • Age >17 years

Exclusion criteria

  • Moderate or severe congestive heart failure
  • History of seizure disorder or demyelinating disease
  • Nursing mothers
  • Pregnancy
  • History of prior tuberculosis or risk factors for tuberculosis
  • 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).
  • Evidence of chronic pancreatitis from history and examination (however, "acute on chronic pancreatitis" diagnosis is allowed)
  • Evidence of active or pending hemorrhage.
  • Paralytic ileus with vomiting

Treatment and study plan

Pentoxifylline

Drug

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.

Other names: Trental

Placebo

Drug

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.

Primary outcomes

  1. Change in C-Reactive Protein (CRP)

    Time frame: baseline, Day 1, Day 3

    C-reactive protein is produced by the liver. The level of CRP rises when there is inflammation throughout the body. The normal value range for CRP = 1-10 mg/L.

  2. Change in Tumor Necrosis Factor (TNF)-Alpha

    Time frame: baseline, Day 1, Day 3

    Normal value range for TNF alpha = 0 - 22 pg/ml.

  3. Change in Interleukin (IL) IL-6

    Time frame: baseline, Day 1, Day 3

    Normal value range for IL-6 = 0 - 5 pg/ml.

  4. Changes in Interleukin (IL) IL-8

    Time frame: baseline, Day 1, Day 3

    Normal value range for IL-8 = 0 - 5 pg/ml.

Secondary outcomes

  1. Number Of Subjects With New Onset Organ Failure During Hospitalization

    Time frame: 1 week or until dismissal date whichever occurs earlier.

  2. Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization

    Time frame: 1 week or until dismissal date whichever occurs earlier

  3. Number of Patients With Lengthy Hospital Stays

    Time frame: 30 days or until dismissal date, whichever occurs earlier

    "Lengthy" was defined as either greater than 4 days or greater than 10 days.

  4. Length of Hospital Stay

    Time frame: 30 days or until dismissal date, whichever occurs earlier

  5. Length of Intensive Care Unit (ICU) Stay

    Time frame: 30 days or until dismissal date, whichever occurs earlier

  6. Number of Subjects Who Needed an Intensive Care Unit Stay

    Time frame: 30 days, or until dismissal, whichever came first

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Pentoxifylline Treatment in Acute Pancreatitis; A Double-Blind Placebo-Controlled Randomized Trial

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Feb 9, 2011
Registry last updated
Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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