Pentoxifylline Treatment of Acute Pancreatitis

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01292005
First received: October 19, 2010
Last updated: February 7, 2013
Last verified: February 2013
  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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  1. Enrollment within 72 hours of diagnosis
  2. Ability to give informed consent
  3. 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 -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292005

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Santhi S Vege, MD Mayo Clinic
  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