This clinical will evaluate the safety, tolerability and early efficacy of pirenidone in patients with recurrent acute pancreatitis.
Patients 18 - 85 years of age
amylase or lipase values, or both, that are greater than 3 times the upper limit of normal values
characteristic cross-sectional imaging
typical upper abdominal pain according to the revised Atlanta classification28
Age < 18 or > 85 years.
Body weight > 200 kg.
Ongoing AP (in right clinical situation defined by pain>3, vomiting ≥once a week, fever or chills, not tolerating light diet) or diagnosis of AP in previous 30 days.
Diagnosis of chronic pancreatitis, one of the following
Parallel
Pirfenidone
DrugPirfenidone Days 1-7: 267 mg PO TID (801 mg/day) Days 8-14: 534 mg PO TID (1602 mg/day) Day 15 and thereafter: 801 mg PO TID; not to exceed 2403 mg/day Duration of treatment- total 6 months
Placebo
DrugPlacebo
Adverse Event
Development of anticipated or un-anticipated serious adverse events (class 3-4)
Development of Recurrent AP
Cumulative incidence and rate of recurrent attacks of AP over 2 year period following randomization into drug/placebo
Severity of Recurrent Attacks of AP
Classified as mild/moderate/severe
ER Visits
Readmissions and/or ER visits for pain but not AP, over 2 years following randomization into drug/placebo
QOL
SF-12 (0-100, higher score means better physical and mental health functioning)
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University of Alabama at Birmingham
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator
