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

Dartmouth-Hitchcock Medical Center

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Pancreatitis

Interventions

PancrelipaseDRUG

Oral Pancrelipase, 720,000 units spread throughout the day with meals and snacks, taken daily PO for 4 weeks

placeboDRUG

Placebo will consist of lactose, spread throughout the day with meals and snacks, taken daily PO for 4 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Outcomes

Primary Outcomes

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

Time frame: Measured at weeks 0,4,6 and 10

Secondary Outcomes

Quality of life

Difference in quality of live evaluated on PANQOLI assessment

Time frame: 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

Time frame: 0, 4, 6 and 10 weeks of treatment

Data from ClinicalTrials.gov

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