An Early Phase 1 interventional study of Pentoxifylline and Placebo in Acute Pancreatitis, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-25.
Sponsored by Mayo Clinic · Early Phase 1, Interventional, and Treatment
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.
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.
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 day for up to 5 days, after the administration of study drug or till the time of discharge whichever occurs earlier. 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.
752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.
This study's enrollment of 28 is below the median of 80 across 448 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Also known as: Trental
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.
Change in C-Reactive Protein (CRP)
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.
Time frame: baseline, Day 1, Day 3
Change in Tumor Necrosis Factor (TNF)-Alpha
Normal value range for TNF alpha = 0 - 22 pg/ml.
Time frame: baseline, Day 1, Day 3
Change in Interleukin (IL) IL-6
Normal value range for IL-6 = 0 - 5 pg/ml.
Time frame: baseline, Day 1, Day 3
Changes in Interleukin (IL) IL-8
Normal value range for IL-8 = 0 - 5 pg/ml.
Time frame: baseline, Day 1, Day 3
Number Of Subjects With New Onset Organ Failure During Hospitalization
Time frame: 1 week or until dismissal date whichever occurs earlier.
Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization
Time frame: 1 week or until dismissal date whichever occurs earlier
Number of Patients With Lengthy Hospital Stays
"Lengthy" was defined as either greater than 4 days or greater than 10 days.
Time frame: 30 days or until dismissal date, whichever occurs earlier
Length of Hospital Stay
Time frame: 30 days or until dismissal date, whichever occurs earlier
Length of Intensive Care Unit (ICU) Stay
Time frame: 30 days or until dismissal date, whichever occurs earlier
Number of Subjects Who Needed an Intensive Care Unit Stay
Time frame: 30 days, or until dismissal, whichever came first
Subjects were enrolled from the Mayo Clinic in Rochester, Minnesota between 2009 and 2012.
| Milestone | Pentoxifylline | Placebo |
|---|---|---|
| Started | 14 | 14 |
| Completed | 14 | 14 |
| Not completed | 0 | 0 |
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.
| mg/L | Pentoxifylline | Placebo |
|---|---|---|
| Change from baseline to Day 1 | 48.4 (-37.1 to 207.3) | 60.6 (-71 to 283.2) |
| Change from baseline to Day 3 | 62 (-157.4 to 255.3) | 154 (-170 to 193.5) |
Normal value range for TNF alpha = 0 - 22 pg/ml.
| pg/ml | Pentoxifylline | Placebo |
|---|---|---|
| Change from baseline to Day 1 | 0 (-1.2 to 0.52) | -0.05 (-0.9 to 49.2) |
| Change from baseline to Day 3 | 0.2 (-1.0 to 0.5) | -0.3 (-3.5 to 17.2) |
Normal value range for IL-6 = 0 - 5 pg/ml.
| pg/ml | Pentoxifylline | Placebo |
|---|---|---|
| Change from baseline to Day 1 | 2.1 (-37 to 25) | 0.7 (-62 to 152) |
| Change from baseline to Day 2 | -8.6 (-61 to 15.6) | -2.9 (-213 to 65.8) |
Normal value range for IL-8 = 0 - 5 pg/ml.
| pg/ml | Pentoxifylline | Placebo |
|---|---|---|
| Change from baseline to Day 1 | -3.0 (-7.2 to 30.8) | -1.7 (-38.2 to 49.2) |
| Change from baseline to Day 3 | 0.35 (-10.3 to 5.4) | -1.9 (-43.6 to 18.2) |
| participants | Pentoxifylline | Placebo |
|---|---|---|
| Number Of Subjects With New Onset Organ Failure During Hospitalization | 0 | 3 |
| participants | Pentoxifylline | Placebo |
|---|---|---|
| Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization | 0 | 2 |
"Lengthy" was defined as either greater than 4 days or greater than 10 days.
| participants | Pentoxifylline | Placebo |
|---|---|---|
| Length of hospitalization >4 days | 2 | 8 |
| Length of hospitalization >10 days | 0 | 5 |
| days | Pentoxifylline | Placebo |
|---|---|---|
| Length of Hospital Stay | 3 (1 to 5) | 5 (1 to 30) |
| Days | Pentoxifylline | Placebo |
|---|---|---|
| Length of Intensive Care Unit (ICU) Stay | 0 (0 to 0) | 0 (0 to 13) |
| participants | Pentoxifylline | Placebo |
|---|---|---|
| Number of Subjects Who Needed an Intensive Care Unit Stay | 0 | 4 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pentoxifylline | — | 0/14 (0%) | 0/14 (0%) |
| Placebo | — | 0/14 (0%) | 0/14 (0%) |
| Age, Continuous(years) | Pentoxifylline | Placebo | Total |
|---|---|---|---|
| Median | 69 (34 to 87) | 58 (24 to 82) | 64 (24 to 87) |
| Sex: Female, Male(Participants) | Pentoxifylline | Placebo | Total |
|---|---|---|---|
| Female | 6 | 5 | 11 |
| Male | 8 | 9 | 17 |
| Region of Enrollment(participants) | Pentoxifylline | Placebo | Total |
|---|---|---|---|
| United States | 14 | 14 | 28 |
| Body Mass Index(kg/m^2) | Pentoxifylline | Placebo | Total |
|---|---|---|---|
| Median | 30.2 (20.6 to 42.9) | 32.5 (16.7 to 50.1) | 30.3 (16.7 to 50.1) |
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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