Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon

Completed · Phase 4

Conditions studied: Cystic Fibrosis, Chronic Pancreatitis

In brief

Exocrine pancreatic insufficiency (EPI) is a condition that is caused by the inadequate pancreatic enzymes needed for normal digestion and is commonly associated with a wide range of chronic diseases, including cystic fibrosis (CF), chronic pancreatitis (CP), and pancreatic cancer. This study will assess clinical symptoms when participants with CF or CP are treated with Creon with alternate source of active drug. Creon is an approved drug for the treatment of EPI. This study is subject-blinded which means participants will not know the source of the study drug they are given. Approximately 30 adult participants with CF or CP will be enrolled at approximately 15 sites across the Unites States. Participants will receive oral capsules of CREON for 113 days and will be followed for 30 days. Participants will attend regular visits during the study at a hospital or clinic or via telemedicine. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Key facts

Study ID

NCT05069597

Run by

AbbVie

People needed

30

Starts

2021-10-14

Expected to finish

2023-08-28

Last updated by the study team

2024-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Previous diagnosis of cystic fibrosis (CF) or chronic pancreatitis (CP).
• Previous diagnosis of exocrine pancreatic insufficiency (EPI) that is currently clinically controlled.
• Total Symptom Score (TSS) < 1.8 on Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) at Screening.

You may not qualify if…

• Malignancy involving the digestive tract in the last 5 years, or other significant disease or medical condition that may interfere with EPI symptom assessment.

Where it is running

• Velocity Clinical Research /ID# 231076 — Mobile, Alabama, United States
• Valley Children's Hospital /ID# 231452 — Madera, California, United States
• University of Florida - Archer /ID# 233411 — Gainesville, Florida, United States
• Atlantic Medical Research /ID# 239568 — Margate, Florida, United States
• University of Miami, Miller School of Medicine /ID# 239415 — Miami, Florida, United States
• GI Pros /ID# 239486 — Naples, Florida, United States
• Central FL Pulmonary Orlando /ID# 245863 — Orlando, Florida, United States
• Asr, Llc /Id# 239566 — Nampa, Idaho, United States
• UMass Chan Medical School /ID# 230476 — Worcester, Massachusetts, United States
• The Curators of the University of Missouri /ID# 233331 — Columbia, Missouri, United States
• Dartmouth-Hitchcock Medical Center /ID# 231633 — Lebanon, New Hampshire, United States
• Albany Medical College-Pulmonary /ID# 250041 — Albany, New York, United States
• NYU Langone Health /ID# 233417 — New York, New York, United States
• Wake Forest Baptist Health /ID# 229537 — Winston-Salem, North Carolina, United States
• University of Cincinnati /ID# 229511 — Cincinnati, Ohio, United States
• UH Cleveland Medical Center /ID# 246065 — Cleveland, Ohio, United States
• Cleveland Clinic Main Campus /ID# 245864 — Cleveland, Ohio, United States
• Options Health Research, LLC /ID# 239535 — Tulsa, Oklahoma, United States
• Baylor College of Medicine Medical Center /ID# 233441 — Houston, Texas, United States
• Univ Texas HSC San Antonio /ID# 239060 — San Antonio, Texas, United States
• West Virginia University Hospitals /ID# 239593 — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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