Early Phase 1 N=28 Randomized Double-blind Treatment

Pentoxifylline Treatment of Acute Pancreatitis

Acute Pancreatitis

Bottom Line

View on ClinicalTrials.gov: NCT01292005 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2013

Primary outcome: Primary: Change in C-Reactive Protein (CRP) — 48.4; 60.6; 62; 154 mg/L — p=0.62

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: Pentoxifylline (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Jul 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in C-Reactive Protein (CRP)	48.4; 60.6; 62; 154	0.62
PRIMARY Change in Tumor Necrosis Factor (TNF)-Alpha	0; -0.05; 0.2; -0.3	0.72
PRIMARY Change in Interleukin (IL) IL-6	2.1; 0.7; -8.6; -2.9	0.58
PRIMARY Changes in Interleukin (IL) IL-8	-3.0; -1.7; 0.35; -1.9	0.90
SECONDARY Number Of Subjects With New Onset Organ Failure During Hospitalization	0; 3	0.09
SECONDARY Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization	0; 2	0.22
SECONDARY Number of Patients With Lengthy Hospital Stays	2; 8; 0; 5	0.04 sig
SECONDARY Length of Hospital Stay	3; 5	0.06
SECONDARY Length of Intensive Care Unit (ICU) Stay	0; 0	0.03 sig
SECONDARY Number of Subjects Who Needed an Intensive Care Unit Stay	0; 4	0.04 sig

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01292005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.