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: October 23, 2013
Last verified: October 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: Pentoxifylline
Drug: Placebo

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:
  • Change in C-Reactive Protein (CRP) [ Time Frame: baseline, Day 1, Day 3 ] [ Designated as safety issue: No ]
    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.

  • Change in Tumor Necrosis Factor (TNF)-Alpha [ Time Frame: baseline, Day 1, Day 3 ] [ Designated as safety issue: No ]
    Normal value range for TNF alpha = 0 - 22 pg/ml.

  • Change in Interleukin (IL) IL-6 [ Time Frame: baseline, Day 1, Day 3 ] [ Designated as safety issue: No ]
    Normal value range for IL-6 = 0 - 5 pg/ml.

  • Changes in Interleukin (IL) IL-8 [ Time Frame: baseline, Day 1, Day 3 ] [ Designated as safety issue: No ]
    Normal value range for IL-8 = 0 - 5 pg/ml.


Secondary Outcome Measures:
  • Number Of Subjects With New Onset Organ Failure During Hospitalization [ Time Frame: 1 week or until dismissal date whichever occurs earlier. ] [ Designated as safety issue: Yes ]
  • Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization [ Time Frame: 1 week or until dismissal date whichever occurs earlier ] [ Designated as safety issue: Yes ]
  • Number of Patients With Lengthy Hospital Stays [ Time Frame: 30 days or until dismissal date, whichever occurs earlier ] [ Designated as safety issue: Yes ]
    "Lengthy" was defined as either greater than 4 days or greater than 10 days.

  • Length of Hospital Stay [ Time Frame: 30 days or until dismissal date, whichever occurs earlier ] [ Designated as safety issue: Yes ]
  • Length of Intensive Care Unit (ICU) Stay [ Time Frame: 30 days or until dismissal date, whichever occurs earlier ] [ Designated as safety issue: No ]
  • Number of Subjects Who Needed an Intensive Care Unit Stay [ Time Frame: 30 days, or until dismissal, whichever came first ] [ Designated as safety issue: Yes ]

Enrollment: 28
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
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.
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.
Other Name: Trental
Placebo Comparator: Placebo
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.
Drug: 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.

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. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: September 23, 2013
Last Updated: October 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
pancreatitis
pancreatic necrosis
severe acute pancreatitis (SAP)
Alcoholic pancreatitis
gallstone pancreatitis

Additional relevant MeSH terms:
Pancreatitis
Digestive System Diseases
Pancreatic Diseases
Pentoxifylline
Antioxidants
Cardiovascular Agents
Enzyme Inhibitors
Free Radical Scavengers
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Protective Agents
Radiation-Protective Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 21, 2014