CompletedPhase IInterventional

Evaluation of acceptability of a new CREON formulation containing Pancreas Powder gastro-resistant pellets for oral use in patients with cystic fibrosis ( CF) suffering from pancreatic exocrine insufficiency type of CF condition, which is characterized by maldigestion due to insufficient endogenous enzyme production and/or secretion

This study is for adults with cystic fibrosis who already take CREON. Researchers want to see if a new form of CREON, which uses the same digestive enzymes as the current capsules but might be easier to swallow, is acceptable to patients. Many people with cystic fibrosis need to take several capsules with meals, and this new form could be more convenient. The study will assess how patients feel about the new CREON, check how well it helps with digestion, and monitor for any side effects. Participants will use their usual CREON for one week, then switch to the new form for another week, keeping a diary of their experience.

At a glance

Status

Completed

Phase

Phase I

Sponsor

Viatris

Enrolment target

120

Start

30 Sep 2024

Estimated completion

30 Nov 2024

Pancreatic exocrine insufficiency

What is this study about?

If you have cystic fibrosis (CF), you might know that your body doesn't always make enough natural enzymes to digest food properly. This can lead to tummy pains, bloating, and problems with your poo. To help with this, many people with CF take enzyme medicines like CREON, which contain important enzymes from pigs that help break down fats, sugars, and proteins.

CREON currently comes in capsules, and sometimes you need to take quite a few at once, which can be a bit tricky or unpleasant. Researchers have developed a new form of CREON that uses the same helpful enzymes but might be easier to take. This study aims to find out if patients living with CF like this new form of CREON and whether they would prefer it over the current capsules. They also want to make sure it's safe and helps with tummy troubles, just like the current capsules.

This is an important step because if the new CREON is easier and more pleasant to take, it could really improve daily life for people with CF. It's about making your medicine work better for you, not just your body, but also your comfort and convenience.

Key takeaways

Tests a new, potentially easier-to-take CREON for cystic fibrosis.
Compares patient experience with current CREON capsules.
Involves taking current CREON for one week, then new CREON for one week.
Main goal is to see if patients like the new formulation.
Participants keep a diary and answer a questionnaire.
Study also monitors safety and digestive symptom control.

Who may be eligible?

This study is looking for adults aged 18 or older who have cystic fibrosis. You must already be taking CREON capsules daily to help with your digestion and have your digestion well-controlled with your current dose.

It's important that you are willing to follow all the study instructions. You cannot take part if you have other serious health problems, are allergic to CREON or any pig products, are pregnant or breastfeeding, or if you've recently taken part in another research study involving a new medicine. Women who can get pregnant must be using effective birth control.

Also, if you've had an acute illness or infection recently, or if you've had issues with alcohol or drug use in the last two years, you might not be able to join. The research team will check all these things carefully to make sure the study is a good fit for you.

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?
Are you currently taking CREON capsules daily for digestion?
Is your digestion well-managed by your current CREON dose?
Are you not pregnant or breastfeeding?
Do you *not* have any known allergies to CREON or pig products?

Answer every question to see your result.

What does participation involve?

If you decide to take part and are suitable, you'll first be asked to sign a consent form. The study will last about three weeks in total. For the first week (called the 'Run-in period'), you'll continue taking your usual CREON capsules, provided by the study, just as you do now. After this, you'll switch to the new CREON formulation for one week, taking it with your meals and snacks. The amount you take will be similar to your regular CREON dose.

Throughout these two weeks, you'll need to keep a diary. In this diary, you'll write down when you take your medicine, how much you take, and if you notice any changes in your digestion or any side effects. One week after you finish taking the new CREON, you'll have a final phone call with the study team. At the end of the treatment period, you'll also fill out a questionnaire to share your thoughts on the new CREON formulation.

Potential risks and benefits

Taking CREON, both the current capsules and the new formulation, may help ease your digestive problems and could even make your symptoms disappear. While we hope this is the case, we can't guarantee it for everyone. The new CREON might also be easier to swallow for some people. As with any medicine, there's always a chance of side effects, even ones we don't know about yet. We expect the new CREON to have similar side effects to the current capsules. However, if the new CREON is not taken correctly, it could cause soreness, irritation, or small painful wounds in your mouth. You are free to stop participating in the study at any time if you wish.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
United Kingdom

Common questions

What is the new CREON formulation?

It's a new way of taking your CREON medicine, designed to be potentially easier to swallow while still containing the same helpful digestive enzymes from pigs.

Why is this new CREON being developed?

It aims to offer a more convenient and pleasant option for people with cystic fibrosis who often need to take several enzyme capsules with their meals.

Will the new CREON work differently from my current capsules?

Both the new and old CREON contain the same active enzymes that help digest food. The study will check if the new form works just as well and is acceptable to patients.

What will I have to do if I join the study?

You'll take your usual CREON for one week, then the new CREON for another week, and keep a diary of your experience. There will also be a follow-up phone call and a questionnaire.

Who is paying for this study?

The study is being funded by Meda Pharma GmbH & Co.KG, which is part of a company called Viatris.

How to find out more

Kristina Marschall

EUClinicalTrials@viatris.com None provided Official trial record

Always speak to your GP or specialist before deciding to take part in a study.