A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)
NCT ID: NCT03859869
Last Updated: 2023-06-05
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
1 participants
INTERVENTIONAL
2020-02-25
2022-03-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase
Resected participants (surgery to remove pancreatic cancer) will first be given low dose pancrelipase. Low dose is defined as 12,000 USP units (lipase) with meals and 6000 U with snacks. At Weeks 1, 5, or 9, participants will be evaluated, and those who meet criteria for dose increase will be given high dose pancrelipase. High dose is defined as 72,000 U with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.
Pancrelipase
Pancrelipase is administered orally as capsules with a meal or snack
Placebo
Placebo is administered orally as capsules with a meal or snack
Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase
Resected participants (surgery to remove pancreatic cancer) will receive and continue on high dose pancrelipase throughout the study. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.
Pancrelipase
Pancrelipase is administered orally as capsules with a meal or snack
Placebo
Placebo is administered orally as capsules with a meal or snack
Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase
Non-resected participants (those who did not have surgery to remove pancreatic cancer) will receive high dose pancrelipase throughout the study in an open-label cohort. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks.
Pancrelipase
Pancrelipase is administered orally as capsules with a meal or snack
Interventions
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Pancrelipase
Pancrelipase is administered orally as capsules with a meal or snack
Placebo
Placebo is administered orally as capsules with a meal or snack
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant's pancreatic cancer must involve the head and/or neck of the pancreas
* Confirmed exocrine pancreatic insufficiency (EPI) as evidenced by fecal elastase-1 (FE-1) ≤ 150 µg/g stool at screening
* A positive Sudan stain for participants without history of fat malabsorption (fat malabsorption is defined as clinical steatorrhea, or measured stool fat \> 7 g/day, or positive stool results by Sudan stain) within 1 week of screening -- Positive stool results are defined as increased level of neutral OR total fats
Exclusion Criteria
* Participant has fibrosing colonopathy
* Participant has any other malignancy within 1 year of screening
* Participant has uncontrolled gout, including those with a recent flare within 60 days of screening
* Participant has other significant organ or bone marrow abnormality within 60 days of screening
21 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Alabama Oncology /ID# 207770
Birmingham, Alabama, United States
Banner University of Arizona Medical Center Phoenix /ID# 208402
Phoenix, Arizona, United States
UCSF Fresno /ID# 205757
Fresno, California, United States
Stanford University School of Med /ID# 208821
Stanford, California, United States
UCH-MHS Memorial Hospital Central /ID# 207093
Colorado Springs, Colorado, United States
UCHealth Cancer Care and Hematology Clinic /ID# 207091
Fort Collins, Colorado, United States
George Washington University Medical Faculty Associates /ID# 203363
Washington D.C., District of Columbia, United States
University of Florida - Archer /ID# 202679
Gainesville, Florida, United States
Columbus Regional Research Institute /ID# 211394
Columbus, Georgia, United States
Northwest Community Hospital /ID# 202270
Arlington Heights, Illinois, United States
NorthShore University HealthSystem /ID# 209026
Evanston, Illinois, United States
Ingalls Memorial Hosp /ID# 203962
Harvey, Illinois, United States
Advocate Christ Medical Center /ID# 203132
Oak Lawn, Illinois, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 204407
Ann Arbor, Michigan, United States
Ascension Providence Hospital /ID# 203449
Southfield, Michigan, United States
St. Louis University /ID# 205769
St Louis, Missouri, United States
Mercy Hospital South /ID# 221766
St Louis, Missouri, United States
Northwell Health Center for Liver Diseases /ID# 207321
Manhasset, New York, United States
NYU Winthrop Hospital /ID# 207513
Mineola, New York, United States
New York University Langone Me /ID# 202290
New York, New York, United States
Columbia University Medical Center /ID# 204165
New York, New York, United States
East Carolina University /ID# 206661
Greenville, North Carolina, United States
Gabrail Cancer Center Research /ID# 208030
Canton, Ohio, United States
Ohio State Cancer Center /ID# 203131
Columbus, Ohio, United States
Fox Chase Cancer Center /ID# 202288
Philadelphia, Pennsylvania, United States
Reading Hospital /ID# 206869
Reading, Pennsylvania, United States
Musc /Id# 210727
Charleston, South Carolina, United States
Tennessee Cancer Specialists /ID# 208235
Knoxville, Tennessee, United States
Vanderbilt University Medical Center /ID# 204231
Nashville, Tennessee, United States
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 206156
Dallas, Texas, United States
UT MD Anderson Cancer Center /ID# 202271
Houston, Texas, United States
Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 205746
Milwaukee, Wisconsin, United States
Medical College of Wisconsin /ID# 205714
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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M16-142
Identifier Type: -
Identifier Source: org_study_id
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