Pancreatitis Clinical Trial
Official title:
A Single-Center Prospective Randomized Placebo Controlled Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic Pancreatitis
The study purpose is to characterize the effect of pancreatic enzyme supplementation on chronic pancreatitis type pain.
Study Type: Interventional, randomized, double-blind, placebo-controlled, crossover design,
efficacy study Intervention arm: Pancreatic enzyme replacement (Pancrelipase) with meals and
snacks daily, for 4 weeks.
Placebo arm: Lactose placebo tablets with meals and snacks, for 4 weeks. Washout Phase: Weeks
4 to 6, there will be cessation of placebo or Pancrelipase use.
Crossover Phase: Weeks 6 to 10, initial placebo arm receives Pancrelipase, Pancrelipase arm
receives placebo
Surveys - Izbicki score and PANQOLI assessment occur at Week 0, 4, 6, and 10. Narcotic and
non-narcotic usage will also be noted at these intervals. Patient will also report the
tobacco and alcohol use.
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