Clinical trial NCT02487225: Pentoxifylline Treatment in Acute Pancreatitis (AP)
Official title: Pentoxifylline Treatment in Acute Pancreatitis: A Double-Blind Placebo - Controlled Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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)
Keywords: Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) pancreatitis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2015-07-01
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Participants were randomized to either the treatment group (Pentoxifylline medication) or the control group (Placebo).

Participant took a pill orally, starting from the time of admission. Participants received a total of 9 doses over the three days of hospitalization (72 hours).

Research blood draws were done at baseline and on 5 successive days or until the time of discharge, whichever occured earlier. The study gathered clinical follow up information up to 4 months following hospitalization regarding the diagnosis of 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

Primary outcomes:
measure: Change in C-reactive Protein (C-RP) From Admission Baseline at One Week.
timeFrame: Admission (baseline), day 5
measure: Change in Tumor Necrosis Factor-alpha (TNF-a) Levels From Admission Baseline at One Week.
timeFrame: Admission (baseline), day 5
measure: Change in Interleukin-6 (IL-6) Levels From Admission Baseline at One Week.
timeFrame: Admission (baseline), day 5
measure: Change in Interleukin-8 (IL-8) Levels From Admission Baseline at One Week.
timeFrame: Admission (baseline), day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Santhi Swaroop Vege, MD
role: PRINCIPAL_INVESTIGATOR
References: