About this trial
The proposed project is focused towards evaluation of Pirfenidone as a novel therapeutic strategy in patients with chronic pancreatitis (CP).
Eligibility criteria
Qualifiers
Patients 18 - 85 years of age
Pancreatic parenchymal and/or ductal calcification
Unequivocal CP on imaging (Tirkes et al3) (Cambridge grade 3 or grade 4)
Average pain of >/=4 (on a 0-10 scale) related to pancreatitis in the past three months [regardless of the use of pain medications (opioids or non-opioids)] and/or evidence of ongoing pancreatic inflammatory activity, with an inflammatory pancreatic flare occurring one or more times within the past six months [inflammatory pancreatic flare is defined as an exacerbation of pancreatic pain in combination with one or more of the following: 1) plasma amylase/lipase levels elevated 2-folds or more than the upper limit of normal; 2) elevated plasma levels of CRP 2-fold or more than the upper normal level without suspicion of other sources such as infection; 3) signs of pancreatic inflammation on cross-sectional imaging]
Disqualifiers
Age < 18 or > 85 years
Pancreatic endotherapy and/or pancreatic surgery and/or celiac plexus block or neurolysis in last 3 months.
Known hypersensitivity to Pirfenidone
AST and/or ALT > times the upper normal limit
Trial design
Treatments tested in this trial
- Pirfenidone 267 mg Oral Tablet
- Placebo
- PROMIS-Global Health
- Comprehensive Pain Assessment Tool
- Brief Pain Inventory
- Pancreatitis Quality of Life Instrument
Treatment groups
Locations
Sponsors and collaborators
Vikas Dudeja
Lead sponsor
University of Iowa
Sponsor institution
United States Department of Defense
Collaborator