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

Phase 2

Withdrawn

• Conditions: Pancreatitis
• Interventions: Drug: placebo; Drug: Pancrelipase

• Registration Number: NCT02706236
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Study Timeline

• Study First Submitted: 2016-02-27
• Study First Submitted QC: 2016-03-07
• Study First Posted: 2016-03-11
• Study Start: 2016-04
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-25
• Last Update Posted: 2018-02-27
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo Arm	placebo	Lactose placebo tablets with meals and snacks, for 4 weeks.
Intervention Arm	Pancrelipase	Pancreatic enzyme replacement (Pancrelipase) with meals and snacks daily, for 4 weeks.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States