A Phase 4 Study to Assess Symptoms of Exocrine Pancreatic Insufficiency in Subjects with Cystic Fibrosis or Chronic Pancreatitis Treated with Creon (Pancrelipase) with an Alternate Source of Active Pharmaceutical Ingredient

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Cystic Fibrosis
    Chronic Pancreatitis
  • Age: Between 18 - 99 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participants must provide written informed consent
    2. Are willing and able to comply with all procedures required in this protocol
    3. Participants must be able to read, and must be willing and capable to use the electronic patient reported outcome (ePRO) device and the platform
    4. Participants have a previous diagnosis of Cystic Fibrosis (CF) or Chronic Pancreatitis (CP)
    5. Participants have a previous diagnosis of EPI that is currently clinically controlled
    6. Participants have a Total Symptom Score (TSS) < 1.8 on PEI-Q at Screening
    7. Participants who are on an individualized, stable dose regimen of commercially available Creon that includes the use of the 24,000 LU capsule strength
    8. Participants who do not have any medical history of any type of malignancy involving the digestive tract in the last 5 years

You may not be eligible for this study if the following are true:

    1. Participants who do not meet all of the inclusion criteria

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.

Contact the research team to learn more about this study.

By clicking "Contact Research Team", your contact information will be sent securely to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.