Pentoxifylline Treatment of Acute Pancreatitis
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Acute Pancreatitis |
Drug: study medication Drug: sugar pill |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Pentoxifylline Treatment in Acute Pancreatitis; A Double-Blind Placebo-Controlled Randomized Trial |
- Changes in CRP [ Time Frame: 1 week ] [ Designated as safety issue: No ]This primary objective of our research is to determine whether inhibition of the TNF-pathway by Pentoxifylline reduces inflammatory markers in severe AP.
- Changes in TNF-alpha [ Time Frame: 1 week ] [ Designated as safety issue: No ]The primary objective of our research is to determine whether inhibition of the TNF-pathway by Pentoxifylline reduces inflammatory markers in severe AP.
- Changes in IL-6 [ Time Frame: 1 week ] [ Designated as safety issue: No ]The primary objective of our research is to determine whether inhibition of the TNF-pathway by Pentoxifylline reduces inflammatory markers in severe AP.
- Changes in IL-8 [ Time Frame: 1 week ] [ Designated as safety issue: No ]The primary objective of our research is to determine whether inhibition of the TNF-pathway by Pentoxifylline reduces inflammatory markers in severe AP.
- Development of organ failure during hospitalization [ Time Frame: 1 week or until dismissal date whichever occurs earlier. ] [ Designated as safety issue: Yes ]This secondary objective of our research is to determine if Pentoxifylline is safe, beneficial and well-tolerated in patients with severe AP.
- Development of pancreatic necrosis during hospitalization. [ Time Frame: 1 week or until dismissal date whichever occurs earlier. ] [ Designated as safety issue: Yes ]This secondary objective of our research is to determine if Pentoxifylline is safe, beneficial and well-tolerated in patients with severe AP.
- Death during hospitalization. [ Time Frame: 1week or until dismissal date whichever occurs earlier. ] [ Designated as safety issue: Yes ]This secondary objective of our research is to determine if Pentoxifylline is safe, beneficial and well-tolerated in patients with severe AP.
- Need for radiologic, endoscopic and/or surgical intervention. [ Time Frame: 1 week or until dismissal date whichever occurs earlier. ] [ Designated as safety issue: Yes ]This secondary objective of our research is to determine if Pentoxifylline is safe, beneficial and well-tolerated in patients with severe AP.
- Length of hospital stay and the need for intensive care. [ Time Frame: 1 week or until dismissal date whichever occurs earlier. ] [ Designated as safety issue: Yes ]This secondary objective of our research is to determine if Pentoxifylline is safe, beneficial and well-tolerated in patients with severe AP.
- Development of serious infection: Culture positive infections in pancreatic/peripancreatic, blood stream, urine or clinical/radiological evidence of pneumonia after initiation of Pentoxifylline. [ Time Frame: 1 week or until dismissal date whichever occurs earlier. ] [ Designated as safety issue: Yes ]This secondary objective of our research is to determine if Pentoxifylline is safe, beneficial and well-tolerated in patients with severe AP.
- Adverse events like hemorrhage and and the most common side effects listed in the drug package insert in the treatment group [ Time Frame: 1 week or until dismissal date whichever occurs earlier. ] [ Designated as safety issue: Yes ]This secondary objective of our research is to determine if Pentoxifylline is safe, beneficial and well-tolerated in patients with severe AP.
| Enrollment: | 30 |
| Study Start Date: | April 2009 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pentoxifylline
Study drug used in study is Pentoxifylline, 400 mg,1 capsule every 8 hours up to maximum of 9 doses
|
Drug: study medication
400 mg, 1 capsule every 8 hours up to maximum of 9 doses.
Other Name: Pentoxifylline
|
|
Placebo Comparator: Placebo
Placebo, 400 mg, 1 capsule every 8 hours up to maximum of 9 doses: control study arm compared to the pentoxifylline study drug.
|
Drug: sugar pill
400 mg, 1 capsule every 8 hours up to maximum of 9 doses.
Other Name: Placebo
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 -
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Santhi S. Vege, M.D., Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01292005 History of Changes |
| Other Study ID Numbers: | 08-006648 |
| Study First Received: | October 19, 2010 |
| Last Updated: | February 7, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
pancreatitis pancreatic necrosis severe acute pancreatitis (SAP) Alcoholic pancreatitis gallstone pancreatitis |
Additional relevant MeSH terms:
|
Pancreatitis Pancreatic Diseases Digestive System Diseases Pentoxifylline Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Platelet Aggregation Inhibitors |
Hematologic Agents Therapeutic Uses Radiation-Protective Agents Protective Agents Physiological Effects of Drugs Vasodilator Agents Cardiovascular Agents Free Radical Scavengers Antioxidants |
ClinicalTrials.gov processed this record on June 18, 2013