Phase 3
N=83
Pentoxifylline Treatment in Acute Pancreatitis (AP)
Acute Pancreatitis (AP) · Gallstone Pancreatitis · Alcoholic Pancreatitis · Trauma Acute Pancreatitis · Hypertriglyceridemia Acute Pancreatitis
Bottom Line
View on ClinicalTrials.gov: NCT02487225 ↗Enrolled (actual)
83
Serious AEs
1.2%
Results posted
Jan 2019
Primary outcome: Primary: Change in C-reactive Protein (C-RP) From Admission Baseline at One Week. — 86.2; 75.8; 116.4; 127.2 mg/L — p=0.5796
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pentoxifylline (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in C-reactive Protein (C-RP) From Admission Baseline at One Week. |
86.2; 75.8; 116.4; 127.2 | 0.5796 |
| PRIMARY Change in Tumor Necrosis Factor-alpha (TNF-a) Levels From Admission Baseline at One Week. |
1.9; 1.8; 4.3; 1.9 | 0.1109 |
| PRIMARY Change in Interleukin-6 (IL-6) Levels From Admission Baseline at One Week. |
107.9; 89.1; 81.8; 88.6 | 0.1236 |
| PRIMARY Change in Interleukin-8 (IL-8) Levels From Admission Baseline at One Week. |
43.7; 31.5; 45.9; 32.1 | 0.157 |
Summary
The purpose of this study was to determine the effects (good and bad) of giving a drug called pentoxifylline to patients with acute pancreatitis.
Eligibility Criteria
Inclusion criteria
- Enrollment within 72 hours of diagnosis of acute pancreatitis (AP)
- Ability to give informed consent or a Legal Adult Representative (LAR) able to give informed consent for subject when needed as defined buy LAR use guidelines.
- Adult subjects of age ≥18 years.
Exclusion Criteria
- Moderate or severe congestive heart failure
- History of seizure disorders or demyelinating disease
- Nursing mothers
- Pregnancy
- History of prior tuberculosis or risk factors for tuberculosis
- Evidence of non- corticosteroid immunosuppression (such as malignancy, chronic renal failure, chemotherapy within 60 days, and HIV)
- Evidence of active hemorrhage
- Paralytic ileus with severe nausea and vomiting
Data sourced from ClinicalTrials.gov (NCT02487225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.