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Study on the Acceptability of Pancreas Powder for Patients with Cystic Fibrosis and Pancreatic Exocrine Insufficiency

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called cystic fibrosis, which affects the lungs and digestive system. People with cystic fibrosis often have a problem called pancreatic exocrine insufficiency, where the pancreas does not produce enough enzymes to help digest food. The trial is testing a new formulation of a medication called Creon, which contains a mix of enzymes, including pancreas powder. These enzymes help break down food so that the body can absorb nutrients better.

The purpose of the study is to evaluate how acceptable this new formulation of Creon is for patients. Participants will take the new Creon formulation, which comes in the form of gastro-resistant pellets, meaning they are designed to withstand stomach acid and dissolve in the intestines. The study will observe how patients feel about taking the medication, including aspects like taste, ease of swallowing, and overall convenience. The trial will also monitor any changes in symptoms such as stool frequency, consistency, and abdominal pain.

Participants will be involved in the study for a period of time, during which they will take the new Creon formulation and provide feedback on their experience. The study will also look at the safety and tolerability of the new formulation, checking for any side effects or issues with the mouth or digestive system. The trial aims to gather information on whether patients would prefer this new formulation over their current treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will begin using a new formulation of Creon containing pancreas powder. This medication is designed to help with digestion by replacing enzymes that the pancreas is unable to produce.

    The medication is taken orally in the form of gastro-resistant capsules, which means they are designed to withstand stomach acid and dissolve in the intestines.

  2. Step 2

    Medication administration

    The patient will take the Creon capsules with each main meal. The exact number of capsules will depend on the patient's current treatment plan and will be determined by the study protocol.

    The patient will continue their usual dose of at least two Creon capsules per main meal, as they have been doing for at least four weeks prior to the study.

  3. Step 3

    Evaluation of treatment acceptability

    On Day 8, the patient will attend Visit 3, where the acceptability of the new Creon formulation will be assessed.

    The assessment will include factors such as ease of opening the container, emptying the dose, taste, tactile sensation, color, time spent taking the dose, general convenience, ease of swallowing, preparation of the final dose, number of dose units, experience of aftertaste, and feeling of fullness after ingestion.

  4. Step 4

    Monitoring and feedback

    Throughout the study, the patient will provide feedback on their experience with the new formulation, including any changes in clinical symptoms such as stool frequency, consistency, abdominal pain, and flatulence.

    Safety and tolerability will also be monitored, including any adverse events or oral mucosal irritation.

  5. Step 5

    Completion of the study

    The study is expected to conclude by September 30, 2024. At the end of the study, the patient will have the opportunity to provide feedback on whether they would switch to the new formulation permanently.

Who can join the trial?

6 criteria

  • Both male and female participants of any ethnic background can join.
  • Participants must be at least 18 years old.
  • Participants should have cystic fibrosis, which is confirmed by two sweat tests or a gene analysis. Cystic fibrosis is a genetic condition that affects the lungs and digestive system.
  • Participants must be currently using PERT (Pancreatic Enzyme Replacement Therapy) with CREON capsules. They should have been on the same dose for at least 4 weeks before joining the study and have good control of symptoms like stool frequency, stool consistency, bloating, gas, and abdominal pain. They should be taking at least two CREON capsules with each main meal.
  • Participants must be willing to follow the study protocol, which means they agree to do what the study requires.
  • Participants need to provide written informed consent, which means they agree in writing to take part in the study after understanding what it involves.

Who cannot join the trial?

3 criteria

  • Patients who do not have cystic fibrosis with pancreatic exocrine insufficiency. This means their pancreas does not produce enough enzymes to help digest food.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means they might need special protection or care.
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Investigated drugs

CREON is a medication used in this clinical trial. It contains Pancreas Powder in the form of gastro-resistant pellets. This medication is designed to help patients with cystic fibrosis who have pancreatic exocrine insufficiency. The trial aims to evaluate how acceptable this new formulation of CREON is for patients, focusing on its ease of use and effectiveness in managing their condition.

What is already known about the treatment

Creon – This medication is administered orally in the form of gastro-resistant pellets. It is currently being evaluated in clinical trials for its acceptability in patients with cystic fibrosis who suffer from pancreatic exocrine insufficiency. Creon is primarily used to aid digestion in individuals whose pancreas does not produce enough enzymes. It works by providing a combination of digestive enzymes that help break down fats, proteins, and carbohydrates in the food. Creon is classified as a pancreatic enzyme replacement therapy.

Investigated diseases

  • Cystic Fibrosis

    Cystic fibrosis is a genetic disorder that affects the respiratory and digestive systems. It is characterized by the production of thick and sticky mucus that can clog the airways and lead to respiratory issues. Over time, this mucus can also block the ducts in the pancreas, preventing digestive enzymes from reaching the intestines. This can result in malnutrition and poor growth due to the body's inability to properly digest and absorb nutrients. The disease is progressive, meaning symptoms typically worsen over time. It is most commonly diagnosed in childhood and requires ongoing management to address respiratory and digestive complications.

  • Pancreatic Exocrine Insufficiency

    Pancreatic exocrine insufficiency is a condition where the pancreas does not produce enough digestive enzymes. This leads to difficulties in digesting food, particularly fats, proteins, and carbohydrates. As a result, individuals may experience symptoms such as weight loss, diarrhea, and malnutrition. The condition often occurs in conjunction with other diseases, such as cystic fibrosis or chronic pancreatitis. It can lead to the malabsorption of nutrients, causing deficiencies and related health issues. Management typically involves enzyme replacement to aid in digestion.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-503256-27-00Protocol codePANC-GRP-3001Estimated enrolment120 patientsSponsorMEDA Pharma GmbH & Co. KG

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