Mayo Clinic
Rochester, Minnesota, 55905, United States
NCT Number: NCT01292005
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.
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Notify Me18 year and older
All sexes
Interventional
Early Phase 1
Rochester, Minnesota, 55905, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: 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.
Time frame: baseline, Day 1, Day 3
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
Normal value range for TNF alpha = 0 - 22 pg/ml.
Time frame: baseline, Day 1, Day 3
Normal value range for IL-6 = 0 - 5 pg/ml.
Time frame: baseline, Day 1, Day 3
Normal value range for IL-8 = 0 - 5 pg/ml.
Time frame: 1 week or until dismissal date whichever occurs earlier.
Time frame: 1 week or until dismissal date whichever occurs earlier
Time frame: 30 days or until dismissal date, whichever occurs earlier
"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
Time frame: 30 days or until dismissal date, whichever occurs earlier
Time frame: 30 days, or until dismissal, whichever came first
Mayo Clinic
Other
Pentoxifylline Treatment in Acute Pancreatitis; A Double-Blind Placebo-Controlled Randomized Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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