Pentoxifylline Treatment of Acute Pancreatitis

Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01292005
• Other study ID #: 08-006648
• Status: Completed
• Phase: N/A
• First received: October 19, 2010
• Last updated: October 23, 2013
• Start date: April 2009
• Est. completion date: July 2012

Study information

• Verified date: October 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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 two days for up to 7 days, starting on the first day. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in C-Reactive Protein (CRP)	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.	baseline, Day 1, Day 3	No
Primary	Change in Tumor Necrosis Factor (TNF)-Alpha	Normal value range for TNF alpha = 0 - 22 pg/ml.	baseline, Day 1, Day 3	No
Primary	Change in Interleukin (IL) IL-6	Normal value range for IL-6 = 0 - 5 pg/ml.	baseline, Day 1, Day 3	No
Primary	Changes in Interleukin (IL) IL-8	Normal value range for IL-8 = 0 - 5 pg/ml.	baseline, Day 1, Day 3	No
Secondary	Number Of Subjects With New Onset Organ Failure During Hospitalization		1 week or until dismissal date whichever occurs earlier.	Yes
Secondary	Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization		1 week or until dismissal date whichever occurs earlier	Yes
Secondary	Number of Patients With Lengthy Hospital Stays	"Lengthy" was defined as either greater than 4 days or greater than 10 days.	30 days or until dismissal date, whichever occurs earlier	Yes
Secondary	Length of Hospital Stay		30 days or until dismissal date, whichever occurs earlier	Yes
Secondary	Length of Intensive Care Unit (ICU) Stay		30 days or until dismissal date, whichever occurs earlier	No
Secondary	Number of Subjects Who Needed an Intensive Care Unit Stay		30 days, or until dismissal, whichever came first	Yes