Pentoxifylline Treatment in Acute Pancreatitis (AP)
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.
Acute Pancreatitis (AP)
Acute on Chronic Pancreatitis
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Pentoxifylline Treatment in Acute Pancreatitis: A Double-Blind Placebo - Controlled Randomized Trial|
- Determine changes in C-reactive protein (C-RP) from admission baseline at one week. [ Time Frame: Admission (baseline) and then 5 consecutive days ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Determine changes in Interleukin-6 (IL-6) levels from admission baseline at one week. [ Time Frame: Admission (baseline) and then 5 consecutive days ] [ Designated as safety issue: No ]
- Determine changes in Interleukin-8 (IL-8) levels from admission baseline at one week. [ Time Frame: Admission (baseline) and then 5 consecutive days ] [ Designated as safety issue: No ]
|Study Start Date:||May 2015|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects to receive up to a maximum of 9 doses.
Pentoxifylline is a competitive nonselective phosphodiesterase inhibitor which raises intracellular cAMP, activates PKA, inhibits TNF and leukotriene synthesis, and reduces inflammation and innate immunity. In addition, pentoxifylline improves red blood cell deformability (known as a haemorrheologic effect), reduces blood viscosity and decreases the potential for platelet aggregation and thrombus formation.Pentoxifylline is also an antagonist at adenosine 2 receptors
Placebo Comparator: Placebo
Placebo 400 mg , 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects to receive up to a maximum of 9 doses.
a harmless pill that has no therapeutic effect, used as a control in testing of investigational drug
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02487225
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Santhi Swaroop Vege, MD||Mayo Clinic|