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 | NYU Langone Health

Go Back to All Clinical Trials

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 years - 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