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

Primary Purpose

Pancreatitis

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pancrelipase
placebo
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention Arm

Placebo Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of life
Difference in quality of live evaluated on PANQOLI assessment
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

Full Information

First Posted
February 27, 2016
Last Updated
February 25, 2018
Sponsor
Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02706236
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Withdrawn
Why Stopped
no funding was awarded
Study Start Date
April 2016 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Active Comparator
Arm Description
Pancreatic enzyme replacement (Pancrelipase) with meals and snacks daily, for 4 weeks.
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
Lactose placebo tablets with meals and snacks, for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Pancrelipase
Intervention Description
Oral Pancrelipase, 720,000 units spread throughout the day with meals and snacks, taken daily PO for 4 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo will consist of lactose, spread throughout the day with meals and snacks, taken daily PO for 4 weeks
Primary Outcome Measure Information:
Title
Change in pain scores based on Izbicki self-assessment score
Description
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 Outcome Measure Information:
Title
Quality of life
Description
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
Title
Change in Narcotic Use
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy B Gardner, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Within the confines of funding sponsors, and department of gastroenterology at Dartmouth
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Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic Pancreatitis

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