Pentoxifylline Treatment in Acute Pancreatitis (AP)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02487225
• Date of registration: 29/06/2015
• Prospective Registration: No
• Primary sponsor: Mayo Clinic
• Public title: Pentoxifylline Treatment in Acute Pancreatitis (AP) AP
• Scientific title: Pentoxifylline Treatment in Acute Pancreatitis: A Double-Blind Placebo - Controlled Randomized Trial
• Date of first enrolment: May 2015
• Target sample size: 83
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02487225
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Santhi Swaroop Vege, MD
• Affiliation: Mayo Clinic

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 100 Years
Gender: All

Health Condition(s) or Problem(s) studied

Miscellaneous (i.e. Acute on Chronic Pancreatitis)

Hypertriglyceridemia Acute Pancreatitis

Acute Pancreatitis (AP)

Alcoholic Pancreatitis

Gallstone Pancreatitis

Idiopathic (Unknown) Acute Pancreatitis

Cancer Acute Pancreatitis

Medication Induced Acute Pancreatitis

Trauma Acute Pancreatitis

Intervention(s)

Drug: Pentoxifylline

Drug: Placebo

Primary Outcome(s)

Change in Tumor Necrosis Factor-alpha (TNF-a) Levels From Admission Baseline at One Week. [Time Frame: Admission (baseline), day 5]

Change in Interleukin-8 (IL-8) Levels From Admission Baseline at One Week. [Time Frame: Admission (baseline), day 5]

Change in Interleukin-6 (IL-6) Levels From Admission Baseline at One Week. [Time Frame: Admission (baseline), day 5]

Change in C-reactive Protein (C-RP) From Admission Baseline at One Week. [Time Frame: Admission (baseline), day 5]

Secondary ID(s)

15-001710

1R21DK101889-01A1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Results

• Results available: Yes
• Date Posted: 23/01/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02487225