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. - PANC-GRP-3001

MEDA Pharma GmbH & Co. KG0 个研究点目标入组 80 人开始时间: 2023年12月7日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•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.

•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., Anticipated non-availability for study visits/procedures., Vulnerable subjects (such as persons kept in detention)., Lack of ability or willingness to give informed consent., History of allergic reaction or hypersensitivity to pancreatin or excipients of CREON or any porc or pig product., Known predisposition to allergies., Positive ß-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)., Clinically relevant acute infections, febrile disease, or any acute condition (illness) two weeks prior to Visit 1 (V1), as judged by the investigator., History of alcohol or drug abuse within the last 2 years., Exposure to another investigational product within the last three months., Lack of willingness to have personal study-related data collected, archived or transmitted according to protocol., Lack of willingness or inability to co-operate adequately.

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