Pentoxifylline Treatment in Acute Pancreatitis (AP)

Gallstone Pancreatitis Clinical Trial

— AP  

Official title:

Pentoxifylline Treatment in Acute Pancreatitis: A Double-Blind Placebo - Controlled Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02487225
• Other study ID #: 15-001710
• Secondary ID: 1R21DK101889-01A
• Status: Completed
• Phase: Phase 3
• Start date: May 2015
• Est. completion date: October 31, 2017

Study information

• Verified date: January 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: October 31, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pancreatitis (AP)
• Alcoholic Pancreatitis
• Cancer Acute Pancreatitis
• Gallstone Pancreatitis
• Gallstones
• Hypertriglyceridemia
• Hypertriglyceridemia Acute Pancreatitis
• Idiopathic (Unknown) Acute Pancreatitis
• Medication Induced Acute Pancreatitis
• Miscellaneous (i.e. Acute on Chronic Pancreatitis)
• Pancreatitis
• Pancreatitis, Chronic
• Trauma Acute Pancreatitis

Intervention

Drug:
• Pentoxifylline
Pentoxifylline is a competitive nonselective phosphodiesterase inhibitor which raises intracellular cyclic adenosine monophosphate (cAMP), activates protein kinase A (PKA), inhibits Tumor Necrosis Factor (TNF) and leukotriene synthesis, and reduces inflammation and innate immunity. In addition, pentoxifylline improves red blood cell deformability (known as a haemorrheologic effect), reduces blood viscosity and decreases the potential for platelet aggregation and thrombus formation.Pentoxifylline is also an antagonist at adenosine 2 receptors
• Placebo
A harmless pill that has no therapeutic effect, used as a control in testing of investigational drug

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in C-reactive Protein (C-RP) From Admission Baseline at One Week.	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	Admission (baseline), day 5
Primary	Change in Tumor Necrosis Factor-alpha (TNF-a) Levels From Admission Baseline at One Week.	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	Admission (baseline), day 5
Primary	Change in Interleukin-6 (IL-6) Levels From Admission Baseline at One Week.	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	Admission (baseline), day 5
Primary	Change in Interleukin-8 (IL-8) Levels From Admission Baseline at One Week.	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	Admission (baseline), day 5