Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic Pancreatitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02706236|
Recruitment Status : Withdrawn (no funding was awarded)
First Posted : March 11, 2016
Last Update Posted : February 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pancreatitis||Drug: Pancrelipase Drug: placebo||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Active Comparator: Intervention Arm
Pancreatic enzyme replacement (Pancrelipase) with meals and snacks daily, for 4 weeks.
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.
Placebo will consist of lactose, spread throughout the day with meals and snacks, taken daily PO for 4 weeks
- 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
- 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
- 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
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
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|
|Principal Investigator:||Timothy B Gardner, MD||Dartmouth-Hitchcock Medical Center|