Open-label single-arm, multicenter clinical trial to evaluate patient acceptability of a new CREON formulation of Pancreas Powder gastro-resistant pellets in patients with cystic fibrosis suffering from pancreatic exocrine insufficiency.
This study focuses on people with Cystic Fibrosis who have problems digesting food due to their pancreas not working well. These patients often take a medicine called Creon. Researchers want to find out how much patients like a new version of Creon, which comes in small, tummy-friendly pellets. They'll be looking at things like how easy the new formulation is to open and swallow, its taste, and overall convenience. The study also checks if patients would prefer to switch to this new form, or use it alongside their current medication, and tracks any changes in their symptoms and overall comfort compared to their usual Creon. It's a small, early-stage study to gather initial feedback.
At a glance
What is this study about?
This clinical trial is designed for people who have Cystic Fibrosis (CF) and experience something called pancreatic exocrine insufficiency. This means their pancreas doesn't produce enough of the special enzymes needed to properly digest food. As a result, people often have trouble absorbing nutrients and may take enzyme medication like Creon to help.
The main goal of this study is to understand how well patients like a new way of taking their Creon medicine. Instead of the usual capsules, this new version comes as tiny pellets that are protected from stomach acid. The researchers want to know if this new form is easier to use, tastes better, or is simply more convenient for patients in their daily lives.
They will be asking participants about lots of different aspects, such as how easy it is to open the container, how the pellets feel in their mouth, if there's any aftertaste, and whether they feel full after taking it. They will also look at whether patients would want to switch to this new formulation and how it affects their everyday symptoms like stomach pain or how often they go to the toilet. This is an early-stage study to get important feedback directly from patients.
Key takeaways
- Study for adults with Cystic Fibrosis and digestive problems.
- Evaluating a new, pellet-based form of Creon medicine.
- Main focus is patient feedback on ease of use, taste, and convenience.
- Also monitors symptoms and whether patients might prefer the new form.
- Early-stage study providing important patient insights.
- Participation involves giving feedback on your experience around Day 8.
Who may be eligible?
To be part of this study, you need to be an adult, 18 years old or older. There is no upper age limit.
Crucially, you must have been diagnosed with Cystic Fibrosis and also suffer from pancreatic exocrine insufficiency. This means your pancreas isn't making enough of the enzymes needed to digest food properly.
Both men and women can take part in this research.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have Cystic Fibrosis?
- Do you also have pancreatic exocrine insufficiency (trouble digesting food)?
- Are you currently taking Creon or similar enzyme replacement therapy?
What does participation involve?
If you join this study, your participation will mainly involve trying out the new Creon formulation over a short period. On what's called 'Visit 3', which is around Day 8 of the study, you'll be asked a series of questions about your experience with the new medicine. These questions will cover everything from how easy it was to open the container and swallow the pellets, to its taste, feel, and overall convenience. You’ll also be asked about any aftertaste or feelings of fullness.
The researchers will also track your normal Creon dose, how many capsules you typically use, and monitor any changes in your symptoms like how often you go to the toilet or if you experience stomach pain or wind. Your mouth will also be checked for any irritation. The total duration of your involvement in the study is quite short, with a focus on this feedback at Day 8.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What is pancreatic exocrine insufficiency?
It means your pancreas isn't making enough natural chemicals (enzymes) to properly digest the food you eat, especially fats.
What is Creon?
Creon is a medicine that replaces the enzymes your pancreas isn't making, helping your body digest food so you can absorb nutrients.
What does 'single-arm open-label' mean?
Single-arm means everyone in the study gets the new Creon formulation. Open-label means both you and the researchers will know you are receiving the new medicine.
Will this new Creon formulation replace my current medication?
Not necessarily. The study aims to understand if patients prefer it, or if it could be used alongside their current treatment. It's not a commitment to switch.
How long will I be involved in the study?
The main feedback for the study is gathered around Day 8. The total involvement is relatively short, focusing on your initial experience with the new formulation.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.