Pentoxifylline Treatment of Acute Pancreatitis

NCT01292005 | Completed Early Phase 1 Results DMC

• 1 other identifier: 08-006648
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effects (good and bad) of giving a drug called pentoxifylline to patients with acute pancreatitis, to see if it can improve blood tests associated with inflammation (tissue damage). Pentoxifylline is approved by the US Food and Drug Administration (FDA) for treatment of circulation problems, but its use in this study is investigational, which means that the FDA has not approved it for the treatment of pancreatitis. However, the FDA has allowed the use of pentoxifylline in this research study.

Conditions

Acute Pancreatitis

Keywords

pancreatitis; pancreatic necrosis; severe acute pancreatitis (SAP); Alcoholic pancreatitis; gallstone pancreatitis

Outcome Measures

Primary Outcomes (4)

• Change in C-Reactive Protein (CRP)

  C-reactive protein is produced by the liver. The level of CRP rises when there is inflammation throughout the body. The normal value range for CRP = 1-10 mg/L.

  baseline, Day 1, Day 3

• Change in Tumor Necrosis Factor (TNF)-Alpha

  Normal value range for TNF alpha = 0 - 22 pg/ml.

  baseline, Day 1, Day 3

• Change in Interleukin (IL) IL-6

  Normal value range for IL-6 = 0 - 5 pg/ml.

  baseline, Day 1, Day 3

• Changes in Interleukin (IL) IL-8

  Normal value range for IL-8 = 0 - 5 pg/ml.

  baseline, Day 1, Day 3

Secondary Outcomes (6)

• Number Of Subjects With New Onset Organ Failure During Hospitalization

  1 week or until dismissal date whichever occurs earlier.

• Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization

  1 week or until dismissal date whichever occurs earlier

• Number of Patients With Lengthy Hospital Stays

  30 days or until dismissal date, whichever occurs earlier

• Length of Hospital Stay

  30 days or until dismissal date, whichever occurs earlier

• Length of Intensive Care Unit (ICU) Stay

  30 days or until dismissal date, whichever occurs earlier

Study Arms (2)

Pentoxifylline

EXPERIMENTAL

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

Drug: Pentoxifylline

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Pentoxifylline DRUG

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

Also known as: Trental

Pentoxifylline

Placebo DRUG

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

Placebo

Eligibility Criteria

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

You may qualify if:

• Predicted Severe Acute Pancreatitis
• Enrollment within 72 hours of diagnosis
• Ability to give informed consent
• Age \>17 years

You may not qualify if:

• Moderate or severe congestive heart failure
• History of seizure disorder or demyelinating disease
• Nursing mothers
• Pregnancy
• History of prior tuberculosis or risk factors for tuberculosis
• Evidence of immunosuppression (malignancy, chronic renal failure, chemotherapy within 60 days, ongoing steroid treatment\*, and HIV)- (\*the exception of prednisone use will be allowed to participate).
• Evidence of chronic pancreatitis from history and examination (however, "acute on chronic pancreatitis" diagnosis is allowed)
• Evidence of active or pending hemorrhage.
• Paralytic ileus with vomiting

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Vege SS, Atwal T, Bi Y, Chari ST, Clemens MA, Enders FT. Pentoxifylline Treatment in Severe Acute Pancreatitis: A Pilot, Double-Blind, Placebo-Controlled, Randomized Trial. Gastroenterology. 2015 Aug;149(2):318-20.e3. doi: 10.1053/j.gastro.2015.04.019. Epub 2015 Jun 23.

  PMID: 26112745 DERIVED

MeSH Terms

Conditions

Pancreatitis; Pancreatitis, Acute Necrotizing; 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

507-284-2175

Study Officials

• Santhi S Vege, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 19, 2010
• First Posted: February 9, 2011
• Study Start: April 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 25, 2016
• Results First Posted: December 13, 2013

Record last verified: 2016-03

Locations

US (1)