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Role of Pancreatic Enzyme Replacement Therapy (PERT) (Creon®) for Pancreatic Exocrine Insufficiency (PEI) after Pancreatic Surgery
EU CTIS ID: 2024-512798-29-00
What this study is testing
To investigate the percentage of patients requiring doses higher than 70k U per main meal.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and female subjects of any ethnic origin.
- Between 18 to 80 (inclusive of both) years of age.
- Have previously undergone total pancreatectomy, performed at least 2 weeks prior to start of the study. Patients with surgery due to pancreatic cancer can be considered for study inclusion even if on adjuvant cancer treatment (i.e., chemotherapy and radiation therapy)
- Evaluated as having related PEI symptoms by the investigator: - CGI of at least moderate and - Presence of nutritional deficit (at least one parameter from lab panel out of normal range).
- On treatment with Proton Pump Inhibitors (if patient is not pre-treated, treatment should be started at Visit 1).
- Willing and able to comply with the requirements of the study protocol (including completion of an eDiary throughout the study).
You likely can't join if
- PEI due non-surgical conditions like pancreatitis, unresectable pancreatic cancer, cystic fibrosis, celiac disease, and Zollinger-Ellison syndrome.
- Women of childbearing potential not using at least one effective method of contraception (preferably one whose effectiveness is not dependent on the user, such as an intrauterine device or implant) at least four weeks prior to dosing and continuing at least 4 weeks following the last treatment.
- Clinically relevant acute infections, febrile disease or any acute condition (illness) two weeks prior to screening, as judged by the investigator.
- Lack of willingness to have personal study-related data collected, archived, or transmitted according to protocol.
- Lack of willingness or inability to co-operate adequately.
- Anticipated non-availability for study visits/procedures.
See the full eligibility criteria
Who can join
- Male and female subjects of any ethnic origin.
- Between 18 to 80 (inclusive of both) years of age.
- Have previously undergone total pancreatectomy, performed at least 2 weeks prior to start of the study. Patients with surgery due to pancreatic cancer can be considered for study inclusion even if on adjuvant cancer treatment (i.e., chemotherapy and radiation therapy)
- Evaluated as having related PEI symptoms by the investigator: - CGI of at least moderate and - Presence of nutritional deficit (at least one parameter from lab panel out of normal range).
- On treatment with Proton Pump Inhibitors (if patient is not pre-treated, treatment should be started at Visit 1).
- Willing and able to comply with the requirements of the study protocol (including completion of an eDiary throughout the study).
- Provide written informed consent.
- Estimated life expectancy in consistency with the study duration.
What rules you out
- PEI due non-surgical conditions like pancreatitis, unresectable pancreatic cancer, cystic fibrosis, celiac disease, and Zollinger-Ellison syndrome.
- Women of childbearing potential not using at least one effective method of contraception (preferably one whose effectiveness is not dependent on the user, such as an intrauterine device or implant) at least four weeks prior to dosing and continuing at least 4 weeks following the last treatment.
- Clinically relevant acute infections, febrile disease or any acute condition (illness) two weeks prior to screening, as judged by the investigator.
- Lack of willingness to have personal study-related data collected, archived, or transmitted according to protocol.
- Lack of willingness or inability to co-operate adequately.
- Anticipated non-availability for study visits/procedures.
- Vulnerable subjects (such as persons kept in detention).
- Gastrointestinal symptoms similar to PEI due to other conditions.
- Chemotherapy/radiotherapy dose during the last week prior to screening.
- On PERT with the same or higher doses than during the first treatment period (lower doses are allowed).
- History of alcohol or drug abuse within the last 2 years which would interfere with the subject’s proper completion of the protocol assignment, as judged by the investigator.
- Exposure to another investigational product within the last three months prior to screening.
- Evidence of severe cardiovascular, respiratory, urogenital, gastrointestinal (including colic fibrosis), hepatic, hematological, immunological, head, ears, eyes, nose, throat (HEENT), dermatological, connective tissue, musculoskeletal, metabolic (including hyperuricemia), nutritional, endocrine, neurologic, psychiatric disease; allergy, major surgery, or any other relevant disease as revealed by history or physical examination which might limit participation in or completion of the study.
- History of allergic reaction or hypersensitivity to pancreatin or excipients of Creon.
- Positive β-human chorionic gonadotropin (β-HCG) pregnancy test, established pregnancy, or breastfeeding at screening.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.