Effect of CREON on Exocrine Pancreatic Insufficiency (EPI) Symptoms

Last updated: March 27, 2024
Sponsor: AbbVie
Overall Status: Completed

Phase

N/A

Condition

Pancreatitis

Primary Biliary Cholangitis

Pancreatic Disorders

Treatment

CREON

Clinical Study ID

NCT04949828
P20-238
  • Ages > 18
  • All Genders

Study Summary

Exocrine Pancreatic Insufficiency (EPI) is a condition where pancreatic enzyme quantity or activity is reduced below threshold needed for normal digestion. Symptoms include bloating, flatulence, diarrhea and steatorrhea. This is an observational study assessing for effect of CREON on symptoms of EPI in participants with EPI due to chronic pancreatitis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Medical history of chronic pancreatitis (CP).
  • Diagnosis of Exocrine Pancreatic Insufficiency (EPI).

Exclusion

Exclusion Criteria:

--History of cystic fibrosis, pancreatic cancer, pancreatic surgery, gastric bypasssurgery, extensive bowel surgery, inflammatory bowel disease, celiac disease, irritablebowel syndrome

Study Design

Total Participants: 63
Treatment Group(s): 1
Primary Treatment: CREON
Phase:
Study Start date:
September 16, 2021
Estimated Completion Date:
February 29, 2024

Connect with a study center

  • Stanford University School of Med /ID# 229530

    Stanford, California 94305-2200
    United States

    Site Not Available

  • University of Florida - Archer /ID# 227057

    Gainesville, Florida 32610
    United States

    Site Not Available

  • John Hopkins University /ID# 227061

    Baltimore, Maryland 21287-0020
    United States

    Site Not Available

  • University of Minnesota - Minneapolis /ID# 227364

    Minneapolis, Minnesota 55455-0341
    United States

    Site Not Available

  • NYU Langone Health /ID# 230818

    New York, New York 10016-2708
    United States

    Site Not Available

  • Duke University Hospital /ID# 227065

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Wake Forest University Health Services /ID# 230816

    Winston-Salem, North Carolina 27157-0001
    United States

    Site Not Available

  • The Ohio State University Wexner Medical Center /ID# 227844

    Columbus, Ohio 43210-1267
    United States

    Site Not Available

  • Medical University of South Carolina /ID# 227213

    Charleston, South Carolina 29425-0001
    United States

    Site Not Available

  • Baylor College of Medicine - Baylor Medical Center /ID# 227067

    Houston, Texas 77030-3411
    United States

    Site Not Available

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