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Pentoxifylline Treatment in Acute Pancreatitis (AP) (AP)

Primary Purpose

Acute Pancreatitis (AP), Gallstone Pancreatitis, Alcoholic Pancreatitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Pentoxifylline
Placebo
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pancreatitis (AP) focused on measuring Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) pancreatitis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pentoxifylline

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
June 29, 2015
Last Updated
January 3, 2019
Sponsor
Mayo Clinic
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02487225
Brief Title
Pentoxifylline Treatment in Acute Pancreatitis (AP)
Acronym
AP
Official Title
Pentoxifylline Treatment in Acute Pancreatitis: A Double-Blind Placebo - Controlled Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
April 30, 2017 (Actual)
Study Completion Date
October 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pentoxifylline
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pentoxifylline
Other Intervention Name(s)
Trental, Pentox, Pentoxil, Flexital
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A harmless pill that has no therapeutic effect, used as a control in testing of investigational drug
Primary Outcome Measure Information:
Title
Change in C-reactive Protein (C-RP) From Admission Baseline at One Week.
Description
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
Time Frame
Admission (baseline), day 5
Title
Change in Tumor Necrosis Factor-alpha (TNF-a) Levels From Admission Baseline at One Week.
Description
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
Time Frame
Admission (baseline), day 5
Title
Change in Interleukin-6 (IL-6) Levels From Admission Baseline at One Week.
Description
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
Time Frame
Admission (baseline), day 5
Title
Change in Interleukin-8 (IL-8) Levels From Admission Baseline at One Week.
Description
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
Time Frame
Admission (baseline), day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Santhi Swaroop Vege, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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Pentoxifylline Treatment in Acute Pancreatitis (AP)

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