Pirfenidone as Treatment of Chronic Pancreatitis

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorVikas Dudeja

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

60 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Vikas Dudeja

Lead sponsor

University of Iowa

Sponsor institution

United States Department of Defense

Collaborator