Trial · NCT02487225
Pentoxifylline Treatment in Acute Pancreatitis (AP)
NCT02487225, Phase 3, Completed, Mayo Clinic; results first posted 2019-01-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pentoxifylline Treatment in Acute Pancreatitis (AP). Trials, record NCT02487225. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02487225
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pentoxifylline Treatment in Acute Pancreatitis (AP)
- NCT number
- NCT02487225
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 83 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
Acute Pancreatitis (AP), Gallstone Pancreatitis, Alcoholic Pancreatitis, Trauma Acute Pancreatitis, Hypertriglyceridemia Acute Pancreatitis, Idiopathic (Unknown) Acute Pancreatitis, Medication Induced Acute Pancreatitis, Cancer Acute Pancreatitis, Miscellaneous (i.e. Acute on Chronic Pancreatitis)
- Interventions
- Pentoxifylline, Placebo
- First posted
- 2015-07-01
- Last updated
- 2019-01-23
- Results first posted
- 2019-01-23
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in C-reactive Protein (C-RP) From Admission Baseline at One Week. | Admission (baseline), day 5 | C-reactive protein is a substance produced by the liver in response to inflammation. Normal C-RP levels are below 3.0 mg/L.Units: mg/L |
| Primary | Change in Tumor Necrosis Factor-alpha (TNF-a) Levels From Admission Baseline at One Week. | Admission (baseline), day 5 | Tumor Necrosis Factor Alpha is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. TNF is important to the body because it helps regulate the response of the immune system to a foreign object, especially to the present cancerous tumor. It promotes inflammation, produces other cells used in the inflammatory response, and can help cells heal. The normal range is 5 to 27.2 pg/ml.Units: pg/ml |
| Primary | Change in Interleukin-6 (IL-6) Levels From Admission Baseline at One Week. | Admission (baseline), day 5 | Interleukin-6 (IL-6) may be used to help evaluate a person who has a condition associated with inflammation, such as lupus or rheumatoid arthritis, or with infection, such as sepsis. It may also be used in the evaluation of diabetes or cardiovascular disease. IL-6 is a cytokine, a protein produced by immune cells that acts on other cells to help regulate and/or promote an immune response. It also stimulates the production of acute phase reactants, proteins that increase in the blood with conditions that cause inflammation or tissue injury. Circulating IL-6 can be found in the blood of normal individuals in the 1 pg/mL range, with slight elevations during the menstrual cycle, modest elevations in certain cancers (melanoma) (10 pg/mL), and large elevations after surgery (30-430 pg/mL).Units: pg/ml |
| Primary | Change in Interleukin-8 (IL-8) Levels From Admission Baseline at One Week. | Admission (baseline), day 5 | IL-8 is a chemotactic factor that attracts neutrophils, basophils, and T-cells, but not monocytes. It is also involved in neutrophil activation. It is released from several cell types in response to an inflammatory stimulus. Units: pg/mL |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in C-reactive Protein (C-RP) From Admission Baseline at One Week. | Admission (baseline), day 5 | Eighteen (18) of forty-five subjects (45) in the treatment arm and eight (8) of thirty-eight (38) subjects in the placebo arm completed the study. Additionally, subjects had blood collections for 5 days or until dismissal. Many subjects were dismissed at 2-3 days. | mg/L | MEAN |
| PRIMARY | Change in Tumor Necrosis Factor-alpha (TNF-a) Levels From Admission Baseline at One Week. | Admission (baseline), day 5 | Eighteen (18) of forty-five subjects (45) in the treatment arm and eight (8) of thirty-eight (38) subjects in the placebo arm completed the study. Additionally, subjects had blood collections for 5 days or until dismissal. Many subjects were dismissed at 2-3 days. | pg/ml | MEAN |
| PRIMARY | Change in Interleukin-6 (IL-6) Levels From Admission Baseline at One Week. | Admission (baseline), day 5 | Eighteen (18) of forty-five subjects (45) in the treatment arm and eight (8) of thirty-eight (38) subjects in the placebo arm completed the study. Additionally, subjects had blood collections for 5 days or until dismissal. Many subjects were dismissed at 2-3 days. | pg/mL | MEAN |
| PRIMARY | Change in Interleukin-8 (IL-8) Levels From Admission Baseline at One Week. | Admission (baseline), day 5 | Eighteen (18) of forty-five subjects (45) in the treatment arm and eight (8) of thirty-eight (38) subjects in the placebo arm completed the study. Additionally, subjects had blood collections for 5 days or until dismissal. Many subjects were dismissed at 2-3 days. | pg/ml | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in C-reactive Protein (C-RP) From Admission Baseline at One Week. | Pentoxifylline | Admission (baseline) | 86.2 | Standard Deviation 81.5 | mg/L |
| Change in C-reactive Protein (C-RP) From Admission Baseline at One Week. | Placebo | Admission (baseline) | 75.8 | Standard Deviation 83.1 | mg/L |
| Change in C-reactive Protein (C-RP) From Admission Baseline at One Week. | Pentoxifylline | Day 5 | 116.4 | Standard Deviation 100.4 | mg/L |
| Change in C-reactive Protein (C-RP) From Admission Baseline at One Week. | Placebo | Day 5 | 127.2 | Standard Deviation 97.8 | mg/L |
| Change in Tumor Necrosis Factor-alpha (TNF-a) Levels From Admission Baseline at One Week. | Pentoxifylline | Admission (baseline) | 1.9 | Standard Deviation 0.9 | pg/ml |
| Change in Tumor Necrosis Factor-alpha (TNF-a) Levels From Admission Baseline at One Week. | Placebo | Admission (baseline) | 1.8 | Standard Deviation 1.3 | pg/ml |
| Change in Tumor Necrosis Factor-alpha (TNF-a) Levels From Admission Baseline at One Week. | Pentoxifylline | Day 5 | 4.3 | Standard Deviation 6.3 | pg/ml |
| Change in Tumor Necrosis Factor-alpha (TNF-a) Levels From Admission Baseline at One Week. | Placebo | Day 5 | 1.9 | Standard Deviation 0.7 | pg/ml |
| Change in Interleukin-6 (IL-6) Levels From Admission Baseline at One Week. | Pentoxifylline | Admission (baseline) | 107.9 | Standard Deviation 124.8 | pg/mL |
| Change in Interleukin-6 (IL-6) Levels From Admission Baseline at One Week. | Placebo | Admission (baseline) | 89.1 | Standard Deviation 138.2 | pg/mL |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pentoxifylline | 45 | |
| Overall Study | STARTED | Placebo | 38 | |
| Overall Study | COMPLETED | Pentoxifylline | 18 | |
| Overall Study | COMPLETED | Placebo | 8 | |
| Overall Study | NOT COMPLETED | Pentoxifylline | 27 | |
| Overall Study | NOT COMPLETED | Placebo | 30 |
Source ClinicalTrials.gov
Adverse events22
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Sepsis due to disease progression | General disorders | Pentoxifylline | 2 | 45 | 2 |
| other | Sepsis due to disease progression | General disorders | Placebo | 0 | 38 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | Pentoxifylline | 0 | 45 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo | 1 | 38 | 1 |
| other | Headache/Migraine | General disorders | Pentoxifylline | 1 | 45 | 1 |
| other | Headache/Migraine | General disorders | Placebo | 2 | 38 | 2 |
| other | Angina | Cardiac disorders | Pentoxifylline | 2 | 45 | 2 |
| other | Angina | Cardiac disorders | Placebo | 0 | 38 | |
| other | Necrosis due to disease progression | Gastrointestinal disorders | Pentoxifylline | 1 | 45 | 1 |
| other | Necrosis due to disease progression | Gastrointestinal disorders | Placebo | 1 | 38 | 1 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pentoxifylline | 2 | 45 |
| Total, all-cause mortality | Placebo | 0 | 38 |
| Total, other adverse events | Pentoxifylline | 12 | 45 |
| Total, other adverse events | Placebo | 5 | 38 |
| Total, serious adverse events | Pentoxifylline | 1 | 45 |
| Total, serious adverse events | Placebo | 0 | 38 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21DK101889 | Oral Pentoxifylline vs. Placebo in Acute Pancreatitis: ... (short title) | VEGE, SANTHI SWAROOP | MAYO CLINIC ROCHESTER | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2015 to 2016 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pentoxifylline vs Placebo: deaths from any cause | Trial comparisons |
| Pentoxifylline vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02487225
GET https://conductscience.org/api/trials/v1/NCT02487225/events?page=2