Pentoxifylline Treatment in Acute Pancreatitis (AP)

NCT02487225 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 15-0017101R21DK101889-01A1
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Pentoxifylline

EXPERIMENTAL

Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects to receive up to a maximum of 9 doses.

Drug: Pentoxifylline

Placebo

PLACEBO COMPARATOR

Placebo 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects to receive up to a maximum of 9 doses.

Drug: Placebo

Interventions

Pentoxifylline DRUG

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

Also known as: Trental, Pentox, Pentoxil, Flexital

Pentoxifylline

Placebo DRUG

A harmless pill that has no therapeutic effect, used as a control in testing of investigational drug

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pancreatitis; Pancreatitis, Alcoholic

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Santhi Swaroop Vege
• Organization: Mayo Clinic

Vege.Santhi@mayo.edu

507-284-7474

Study Officials

• Santhi Swaroop Vege, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 1, 2015
• Study Start: May 1, 2015
• Primary Completion: April 30, 2017
• Study Completion: October 31, 2017
• Last Updated: January 23, 2019
• Results First Posted: January 23, 2019

Record last verified: 2019-01

Locations

US (1)