Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pentoxifylline | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pentoxifylline | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, Day 1, Day 3 |
| Change in Tumor Necrosis Factor (TNF)-Alpha | Normal value range for TNF alpha = 0 - 22 pg/ml. | baseline, Day 1, Day 3 |
| Change in Interleukin (IL) IL-6 | Normal value range for IL-6 = 0 - 5 pg/ml. | baseline, Day 1, Day 3 |
| Changes in Interleukin (IL) IL-8 | Normal value range for IL-8 = 0 - 5 pg/ml. | baseline, Day 1, Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number Of Subjects With New Onset Organ Failure During Hospitalization | 1 week or until dismissal date whichever occurs earlier. | |
| Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization | 1 week or until dismissal date whichever occurs earlier |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Santhi S Vege, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26112745 | Derived | Vege SS, Atwal T, Bi Y, Chari ST, Clemens MA, Enders FT. Pentoxifylline Treatment in Severe Acute Pancreatitis: A Pilot, Double-Blind, Placebo-Controlled, Randomized Trial. Gastroenterology. 2015 Aug;149(2):318-20.e3. doi: 10.1053/j.gastro.2015.04.019. Epub 2015 Jun 23. |
Not provided
Not provided
30 subjects signed informed consent; two subjects were excluded after consent because they were found to be not eligible.
Subjects were enrolled from the Mayo Clinic in Rochester, Minnesota between 2009 and 2012.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pentoxifylline | 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. |
| FG001 | Placebo | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pentoxifylline | 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. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Full Range | mg/L | baseline, Day 1, Day 3 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pentoxifylline | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Santhi Swaroop Vege | Mayo Clinic | 507-284-2175 | vege.santhi@mayo.edu |
Not provided
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D019283 | Pancreatitis, Acute Necrotizing |
| D019512 | Pancreatitis, Alcoholic |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D010431 | Pentoxifylline |
| ID | Term |
|---|---|
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | 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. |
|
| Number of Patients With Lengthy Hospital Stays | "Lengthy" was defined as either greater than 4 days or greater than 10 days. | 30 days or until dismissal date, whichever occurs earlier |
| Length of Hospital Stay | 30 days or until dismissal date, whichever occurs earlier |
| Length of Intensive Care Unit (ICU) Stay | 30 days or until dismissal date, whichever occurs earlier |
| Number of Subjects Who Needed an Intensive Care Unit Stay | 30 days, or until dismissal, whichever came first |
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Median | Full Range | kg/m^2 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Change in Tumor Necrosis Factor (TNF)-Alpha | Normal value range for TNF alpha = 0 - 22 pg/ml. | Posted | Median | Full Range | pg/ml | baseline, Day 1, Day 3 |
|
|
|
|
| Primary | Change in Interleukin (IL) IL-6 | Normal value range for IL-6 = 0 - 5 pg/ml. | Posted | Median | Full Range | pg/ml | baseline, Day 1, Day 3 |
|
|
|
|
| Primary | Changes in Interleukin (IL) IL-8 | Normal value range for IL-8 = 0 - 5 pg/ml. | Posted | Median | Full Range | pg/ml | baseline, Day 1, Day 3 |
|
|
|
|
| Secondary | Number Of Subjects With New Onset Organ Failure During Hospitalization | Posted | Number | participants | 1 week or until dismissal date whichever occurs earlier. |
|
|
|
|
| Secondary | Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization | Posted | Number | participants | 1 week or until dismissal date whichever occurs earlier |
|
|
|
|
| Secondary | Number of Patients With Lengthy Hospital Stays | "Lengthy" was defined as either greater than 4 days or greater than 10 days. | Posted | Number | participants | 30 days or until dismissal date, whichever occurs earlier |
|
|
|
|
| Secondary | Length of Hospital Stay | Posted | Median | Full Range | days | 30 days or until dismissal date, whichever occurs earlier |
|
|
|
|
| Secondary | Length of Intensive Care Unit (ICU) Stay | Posted | Median | Full Range | Days | 30 days or until dismissal date, whichever occurs earlier |
|
|
|
|
| Secondary | Number of Subjects Who Needed an Intensive Care Unit Stay | Posted | Number | participants | 30 days, or until dismissal, whichever came first |
|
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Placebo | 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. | 0 | 14 | 0 | 14 |
Not provided
Not provided
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Wilcoxon (Mann-Whitney) |
| 0.50 |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) |
| 0.80 |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) |
| 0.56 |
| 95 |
| No |
| Superiority or Other |
| t-test, 2 sided |
| 0.03 |
| 95 |
| No |
| Superiority or Other |