Pentoxifylline Treatment of Acute Pancreatitis
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2009 |
| End Date: | July 2012 |
Pentoxifylline Treatment in Acute Pancreatitis; A Double-Blind Placebo-Controlled Randomized Trial
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.
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.
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.
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.
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
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