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

Dartmouth Health

Status and phase: Withdrawn; Phase 2

Conditions: Pancreatitis

Treatments: Drug: Pancrelipase; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02706236

D16084

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Intervention Arm

Active Comparator group

Description:

Pancreatic enzyme replacement (Pancrelipase) with meals and snacks daily, for 4 weeks.

Treatment:

Drug: Pancrelipase

Placebo Arm

Placebo Comparator group

Description:

Lactose placebo tablets with meals and snacks, for 4 weeks.

Treatment:

Drug: placebo