Clinical Trial: Pentoxifylline Treatment in Acute Pancreatitis (AP)
Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional
Official Title: Pentoxifylline Treatment in Acute Pancreatitis: A Double-Blind Placebo - Controlled Randomized Trial
Brief Summary:
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.
Detailed 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.
Sponsor: Mayo Clinic
Current Primary Outcome:
- Determine changes in C-reactive protein (C-RP) from admission baseline at one week. [ Time Frame: Admission (baseline) and then 5 consecutive days ]
- Determine changes in Tumor Necrosis Factor-alpha (TNF-a) levels from admission baseline at one week. [ Time Frame: Admission (baseline) and then 5 consecutive days ]
- Determine changes in Interleukin-6 (IL-6) levels from admission baseline at one week. [ Time Frame: Admission (baseline) and then 5 consecutive days ]
- Determine changes in Interleukin-8 (IL-8) levels from admission baseline at one week. [ Time Frame: Admission (baseline) and then 5 consecutive days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Mayo Clinic
Dates:
Date Received: June 29, 2015
Date Started: May 2015
Date Completion: June 2017
Last Updated: September 14, 2016
Last Verified: January 2016
