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

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ClinicalTrials.gov Identifier: NCT02706236
Recruitment Status : Withdrawn (no funding was awarded)
First Posted : March 11, 2016
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
Timothy Gardner, Dartmouth-Hitchcock Medical Center

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

Condition or disease Intervention/treatment Phase
Pancreatitis Drug: Pancrelipase Drug: placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Single-Center Prospective Randomized Placebo Controlled Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic Pancreatitis
Estimated Study Start Date : April 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Active Comparator: Intervention Arm
Pancreatic enzyme replacement (Pancrelipase) with meals and snacks daily, for 4 weeks.
Drug: Pancrelipase
Oral Pancrelipase, 720,000 units spread throughout the day with meals and snacks, taken daily PO for 4 weeks

Placebo Comparator: Placebo Arm
Lactose placebo tablets with meals and snacks, for 4 weeks.
Drug: placebo
Placebo will consist of lactose, spread throughout the day with meals and snacks, taken daily PO for 4 weeks




Primary Outcome Measures :
  1. Change in pain scores based on Izbicki self-assessment score [ Time Frame: 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 :
  1. Quality of life [ Time Frame: Pancreatic Quality of Life Instrument (PANQOLI) assessment at weeks 0, 4, 6 and 10 ]
    Difference in quality of live evaluated on PANQOLI assessment

  2. Change in Narcotic Use [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02706236


Locations
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United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
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Principal Investigator: Timothy B Gardner, MD Dartmouth-Hitchcock Medical Center

Publications:
Pancreatic Enzyme Supplementation for Treatment of Pain in Adult Patients with Chronic Pancreatitis: a Meta-Analysis and Systematic Review [abstract]. Gardner TB, Michalak D, Harrington MW, et al
US Food and Drug Administration. FDA Approves Pancreatic Enzyme Replacement Product for Marketing in United States. Creon designed to help those with cystic fibrosis, others with exocrine pancreatic insufficiency. May 7th, 2009. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149579.htm

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Responsible Party: Timothy Gardner, Associate Professor of Medicine, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02706236     History of Changes
Other Study ID Numbers: D16084
First Posted: March 11, 2016    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Within the confines of funding sponsors, and department of gastroenterology at Dartmouth
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents