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
Research summary
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.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