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

Study Identifier
M21-432
CT.gov Identifier
NCT05069597
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
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Scientific Result Summary
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Plain Language Summary
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Study Details

Medical Condition
  • Cystic Fibrosis
  • Liver, Pancreas & Gallbladder - Other
    • Study Drug
  • CREON
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * 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.
    Exclusion Criteria:
    \- Malignancy involving the digestive tract in the last 5 years, or other significant disease or medical condition that may interfere with EPI symptom assessment.

    Protocol Summary

    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.

    Study Locations

    Location
    Status
    Location
    Velocity Clinical Research /ID# 231076
    Mobile, Alabama, United States, 36608-1771
    Status
    Not applicable
    Location
    Valley Children's Hospital /ID# 231452
    Madera, California, United States, 93636
    Status
    Not applicable
    Location
    University of Florida - Archer /ID# 233411
    Gainesville, Florida, United States, 32610
    Status
    Not applicable
    Location
    Atlantic Medical Research /ID# 239568
    Margate, Florida, United States, 33063-5737
    Status
    Not applicable
    Location
    University of Miami, Miller School of Medicine /ID# 239415
    Miami, Florida, United States, 33136
    Status
    Not applicable
    Location
    GI Pros /ID# 239486
    Naples, Florida, United States, 34102-5449
    Status
    Not applicable
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