CREON formulation of Pancreas Powder gastro-resistant pellets in patients with cystic fibrosis
Research type
Research Study
Full title
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.
IRAS ID
1008425
Contact name
Joachim Maus
Contact email
Sponsor organisation
Meda Pharma GmbH & Co. KG (A Viatris Company)
Eudract number
2023-503256-27
ISRCTN Number
ISRCTN13375864
Research summary
Summary of Research
This is an open-label single-arm, multicenter Phase I study testing a new CREON formulation of Pancreas Powder gastro-resistant pellets in patients with cystic fibrosis (CF) who suffer from pancreatic exocrine insufficiency (PEI).
Pancreatic enzyme replacement therapy (PERT) is considered as standard therapy for the nutritional management of PEI. For this purpose, such so-called Pancreatin products like CREON have been marketed for decades.
The study is designed to assess study participants' acceptability of a new CREON formulation containing Pancreas Powder gastro-resistant pellets. As CREON new formulation is not registered, the present study is designed as Phase I clinical trial.
A total number of 120 patients with cystic fibrosis and on treatment with PERT (CREON capsules) will participate in this study if meeting the eligibility criteria and upon signing an Informed Consent Form.
The study will begin with a one-week Run-in period. During this time study participants will continue using their standard PERT treatment with CREON capsules provided by the sponsor. After that week, study participants will be enrolled into the study (Visit 2) and administer CREON new formulation in a dose-comparable manner for one week (until Visit 3).
Treatment will be administered per oral (PO) per meal/snack for 7 days. All selected study participants have been diagnosed with CF and are already on regular PERT treatment with CREON capsules.
A final follow-up telephone call will be scheduled one week after Visit 3.
Participants will be instructed to record the date, time, dose of CREON administered, number of capsules/new formulation, circumstance of use, location of use as well as clinical symptoms, adverse event occurrence, use of medication for acute conditions, as well as local tolerability in a paper-based diary. At the end of the treatment, patients will be answering a questionnaire which will help to know about the acceptability of the new formulation.Summary of Results
This study looked at how people with cystic fibrosis felt about a new form of CREON, a medicine for digestion.
Cystic fibrosis (CF) affects the pancreas, which helps break down food. In people with cystic fibrosis, the pancreas does not make enough enzymes that help in digesting the food. Without these enzymes, one may experience stomach pain, constipation, or diarrhea after having a meal.
CREON is a medicine that replaces these enzymes. It is usually taken as capsules. But taking many capsules every day can be hard. So, a new form of CREON was made. This new form has the same enzymes as the capsules.
A company called Viatris did this study at 8 places in the UK and Germany. In total, 58 patients with CF took part in the study. Among them were 30 women and 28 men. The people in the study were between 19 and 62 years old. They were already using CREON capsules, and their symptoms were under control. It was an early test of the new form. All patients in the study got the same medicine. Both doctors and patients knew which medicine was being tested in the study.
This was a three-week study. In the first week, patients took their usual CREON capsules. In the second week, they used the new form. In the third week, they had a follow-up call.
Most patients said the new form was easy to use. Some said the taste and preparation could be better. Only one patient wanted to switch fully to the new form. Others liked taking capsules or a mix of both forms.
No serious side effects happened during the trial. Some patients had mild problems like gas or sore mouth. Overall, the new form was safe. The patients’ feedback received from this study will help make the medicine better for people with cystic fibrosis who have trouble digesting food.REC name
London - Chelsea Research Ethics Committee
REC reference
24/LO/0031
Date of REC Opinion
22 Jul 2024
REC opinion
Further Information Favourable Opinion