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.
Key facts
- Where
- Berlin, Essen, Heidelberg, Jena és Munich, NémetországSee the 6 sites
- Phase
- 1. fázis
Where in Németország
- Charite Universitaetsmedizin Berlin KöRBerlin, NémetországNo longer taking part
- Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbHEssen, NémetországNo longer taking part
- Universitaetsklinikum Heidelberg AöRHeidelberg, NémetországNo longer taking part
- Universitaetsklinikum Jena KöRJena, NémetországNo longer taking part
- Klinikum der Universität München - Medizinische Klinik VMunich, NémetországNo longer taking part
- Pneumologisches Studienzentrum München-WestMunich, NémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- MEDA Pharma GmbH & Co. KG
- Trial code
- EU 2023-503256-27-00
- Record updated
- 2024. szeptember 12.
- Original description
Evaluation of acceptability of a new CREON formulation containing Pancreas Powder gastro-resistant pellets.Read full original descriptionShow less
Evaluation of acceptability of a new CREON formulation containing Pancreas Powder gastro-resistant pellets.
Inclusion: Male and female subjects of any ethnic origin; At least 18 years of age; Cystic fibrosis (documented by two sweat tests or by gene analysis); On treatment with PERT with CREON capsules on the current dose for at least 4 weeks prior to entry in the study and with satisfactory symptom control (e.g. stool frequency and consistency, meteorism/flatulence, abdominal pain) with a dose of at least two CREON capsules per main meal; Willing to comply with the requirements of the study protocol; Written informed consent.
Exclusion: Positive β-human chorionic gonadotropin (hCG) pregnancy test, established pregnancy, or breast-feeding at Visit V1. Women of childbearing potential not using at least one effective method of contraception (preferably one whose effectiveness is not dependent on the user, such as an intrauterine device or implant). Women on oral hormonal contraceptives or vaginal ring must agree to use another non-hormonal acceptable highly effective method of contraception in addition to the oral hormonal contraception or vaginal ring; Clinically relevant acute infections, febrile disease or any acute condition (illness) two weeks prior to Visit V1, as judged by investigator; Exposure to another investigational product within the last three months; Evidence of severe disease, or any other relevant condition (other than CF) as revealed by history or physical examination which might limit participation in or completion of the study; History of allergic reaction or hypersensitivity to pancreatin or excipients of CREON (e.g. lipase, amylase, protease, dimethicone, gelatin, xanthan gum, citric acid, red colorant), or any pork or pig product); Known predisposition to allergies (relevance as judged by the investigator); History of alcohol or drug abuse within the last 2 years; Evidence of rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency; Lack of willingness or inability to co-operate adequately; Anticipated non-availability for study visits/procedures; Vulnerable subjects (such as persons kept in detention); Lack of ability or willingness to give informed consent; Lack of willingness to have personal study-related data collected, archived, or transmitted according to protocol.