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Role of Pancreatic Enzyme Replacement Therapy (PERT) (Creon®) in Pancreatic Exocrine Insufficiency (PEI) due to gastrectomy.
EU CTIS ID: 2023-507837-18-00
What this study is testing
To evaluate the effect of Creon as PERT on the nutritional status of the patient with PEI developed post-gastrectomy.
- Therapeutic use (Phase IV)
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 participants of any ethnic origin.
- Participants between 18 to 80 (inclusive of both) years of age.
- Willing to comply with the requirements of the study protocol.
- Provide written informed consent.
- Have previously undergone total gastrectomy.
- Participant with pancreatic exocrine insufficiency as evidenced by clinical symptoms and confirmed by fecal elastase test.
You likely can't join if
- On treatment with medications like somatostatin or aprotinin that directly influence pancreatic exocrine function.
- Anticipated non-availability for study visits/procedures.
- Vulnerable subjects (such as persons kept in detention).
- Previously taken Creon or any other PERT product within last 1 week prior to Day 1 of pretreatment phase.
- Evidence of severe cardiovascular, respiratory, urogenital, gastrointestinal, hepatic, hematological, immunological, head, ears, eyes, nose, throat (HEENT), dermatological, connective tissue, musculoskeletal, metabolic (other than CF), 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.
See the full eligibility criteria
- Male and female participants of any ethnic origin.
- Participants between 18 to 80 (inclusive of both) years of age.
- Willing to comply with the requirements of the study protocol.
- Provide written informed consent.
- Have previously undergone total gastrectomy.
- Participant with pancreatic exocrine insufficiency as evidenced by clinical symptoms and confirmed by fecal elastase test.
- Participant should not be receiving chemotherapy/radiotherapy during the last week prior to enrollment into the treatment phase.
- Participant should not have exposure to any other investigational product within the last three months prior to enrollment into the treatment phase.
- On treatment with medications like somatostatin or aprotinin that directly influence pancreatic exocrine function.
- Anticipated non-availability for study visits/procedures.
- Vulnerable subjects (such as persons kept in detention).
- Previously taken Creon or any other PERT product within last 1 week prior to Day 1 of pretreatment phase.
- Evidence of severe cardiovascular, respiratory, urogenital, gastrointestinal, hepatic, hematological, immunological, head, ears, eyes, nose, throat (HEENT), dermatological, connective tissue, musculoskeletal, metabolic (other than CF), 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 (hCG) pregnancy test, established pregnancy, or breast-feeding at Day 1 of pretreatment phase. - 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).
- Clinically relevant acute infections, febrile disease or any acute condition (illness) two weeks prior to Day 1 of pretreatment phase, as judged by the investigator.
- History of alcohol or drug abuse within the last 2 years.
- Lack of willingness to have personal study-related data collected, archived, or transmitted according to protocol.
- Lack of willingness or inability to co-operate during the conduct of the study, adequately.
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, 65+ years, 18-64 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.