Expired Study
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Rochester, Minnesota 55905


Purpose:

This is a single center randomized, double-blind, placebo-controlled study, to be conducted at Mayo Clinic, Rochester, MN. The objective of our research is to determine whether inhibition of the tumor necrosis factor- alpha (TNF-a) pathway by Pentoxifylline reduces inflammatory markers in AP and whether it is safe, beneficial and well-tolerated in patients with acute pancreatitis AP. The study will have 2 groups of 75 patients each, all with AP, randomly assigned to either the drug or a placebo, which looks like the drug, for a period of 3 days or until the time they are discharged, if hospital discharge is within 7 days of admission. The levels of markers of inflammation of C-reactive protein (C-RP), Interleukin-6 (IL-6), Interleukin-8 (IL-8) and Tumor Necrosis Factor-alpha (TNF-a) will be measured at baseline and on 5 successive days or until the time of discharge, whichever occurs earlier. Subjects will be adult patients =18 years or older admitted to the hospital within 72 hours of diagnosis of acute pancreatitis (AP) as defined by at least two of the following: (1) amylase and/or lipase greater than 3x upper limit of normal, (2) characteristic cross-sectional imaging, (3) typical abdominal pain. Enrollment into the study should take place 24 hours of admission. Determination of group size was based on the previous pilot study to decrease any of the important adverse outcomes, providing for a dropout rate of 10% during the study. During 2012, 263 patients with AP were admitted to this institution, which possesses the needed infrastructure for successful completion of clinical drug intervention trials.


Study summary:

Participants will be put in one of two groups (randomized) by chance (as flip of a coin). This is done so that neither participant nor the investigator will know which group you are in. Subject will be in either the treatment group (Pentoxifylline medication) or the control group (Placebo). Placebo is a matching pill that has no medication in it. Participant will take a pill orally (by mouth) starting from the time of admission and enrollment. Participant will receive a total of 9 doses over the three days of hospitalization (72 hours). Research blood draws will be done to be measured at baseline and on 5 successive days or until the time of discharge, whichever occurs earlier. The research blood draws can be done at the time of standard patient care blood draws, when a little extra (10 mL or 2 teaspoons) is drawn for the research. Information from participant 's medical record will be gathered while hospitalized and after dismissal. The study will continue to gather clinical follow up information up to 4 months following hospitalization regarding the diagnosis of acute pancreatitis.


Criteria:

Inclusion criteria - Enrollment within 72 hours of diagnosis of AP - Ability to give informed consent or a legal adult representative LAR able to give informed consent for subject when needed as defined buy LAR use guidelines. - Adult subjects of age ≥18 years. Exclusion Criteria: - Moderate or severe congestive heart failure, - History of seizure disorders or demyelinating disease, - Nursing mothers, - Pregnancy, - History of prior tuberculosis or risk factors for tuberculosis - Evidence of non- corticosteroid immunosuppression (such as malignancy, chronic renal failure, chemotherapy within 60 days, and HIV) - Evidence of active hemorrhage, - Paralytic ileus with severe nausea and vomiting.


NCT ID:

NCT02487225


Primary Contact:

Principal Investigator
Santhi Swaroop Vege, MD
Mayo Clinic


Backup Contact:

N/A


Location Contact:

Rochester, Minnesota 55905
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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