Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic Pancreatitis

Study Overview
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Brief Summary
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The study purpose is to characterize the effect of pancreatic enzyme supplementation on chronic pancreatitis type pain.

Detailed Description
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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.

Official Title
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A Single-Center Prospective Randomized Placebo Controlled Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic Pancreatitis

Conditions
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Pancreatitis

Intervention / Treatment
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* Drug: Pancrelipase
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of chronic pancreatitis based on chronic pancreatitis-type pain > 6 months leading to impaired quality of life AND at least 1 of the following (27): Confirmed diagnosis of hereditary pancreatitis (PRSS1 gene mutation) History of recurrent acute pancreatitis (>1 documented episode of characteristic abdominal pain associated with diagnostic imaging and/or elevated serum amylase or lipase > 3 times upper limit of normal). Pancreatic calcifications on CT scan At least 2 of the following: Endoscopic Ultrasound (EUS) with = or > 4 criteria for chronic pancreatitis (hyperechoic foci, strands, or ducts, lobulation, irregular duct margin, visible side - branches, calcifications, cysts, ductal dilatation) (28) Ductal (changes in side branch morphology) or parenchymal (loss of T1 signal intensity) abnormalities on secretin enhanced Magnetic resonance cholangiopancreatography (MRCP) Abnormal endoscopic pancreatic secretory function tests (HCO3 <= 75mmol/L at 30 or 45 minutes or <= 80mmol/L at 1 hour Subjects are capable of informed consent Exclusion Criteria: Pregnancy Lactation Active acute pancreatitis or an episode of acute pancreatitis within 2 months of presentation for evaluation Pancreatic cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Arm<br>Pancreatic enzyme replacement (Pancrelipase) with meals and snacks daily, for 4 weeks. | Drug: Pancrelipase<br>* Oral Pancrelipase, 720,000 units spread throughout the day with meals and snacks, taken daily PO for 4 weeks<br>|
| Placebo Comparator: Placebo Arm<br>Lactose placebo tablets with meals and snacks, for 4 weeks. | Drug: placebo<br>* Placebo will consist of lactose, spread throughout the day with meals and snacks, taken daily PO for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain scores based on Izbicki self-assessment score | Difference in pain scores based on Izbicki self-assessment will be evaluated to determine if pancrelipase improves pain symptoms in patients with chronic pancreatitis | Measured at weeks 0,4,6 and 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Difference in quality of live evaluated on PANQOLI assessment | Pancreatic Quality of Life Instrument (PANQOLI) assessment at weeks 0, 4, 6 and 10 | 
| Change in Narcotic Use | Difference in narcotic and non-narcotic use at 0, 4, 6 and 10 weeks of treatment as measured by morphine equivalents | 0, 4, 6 and 10 weeks of treatment |