Clinical trial NCT02706236: Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic Pancreatitis
Official title: A Single-Center Prospective Randomized Placebo Controlled Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic Pancreatitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Pancreatitis
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2016-03-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study purpose is to characterize the effect of pancreatic enzyme supplementation on chronic pancreatitis type pain.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pain scores based on Izbicki self-assessment score
timeFrame: Measured at weeks 0,4,6 and 10
Secondary outcomes:
measure: Quality of life
timeFrame: Pancreatic Quality of Life Instrument (PANQOLI) assessment at weeks 0, 4, 6 and 10
measure: Change in Narcotic Use
timeFrame: 0, 4, 6 and 10 weeks of treatment
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Timothy B Gardner, MD
role: PRINCIPAL_INVESTIGATOR
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