Stereoselective pharmacokinetics and CYP2C19-genotyping as outcome predictors of an esomeprazole therapy in patients with GERD -- a pilot study (phase IV-study)

Medical Faculty, Otto-von-Guericke University0 个研究点目标入组 0 人开始时间: 2008年4月21日最近更新: 2022年8月8日

试验速览

暂无简介。

•- male and female
•- Caucasians
•- 20-70 years old
•- 50-85 kg body weight
•- patients with GERD, grade A and B Los Angeles classification
•- otherwise inconspicuous physical examination and clinical laboratory parameters
•- signed written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- therapy with proton pump inhibitors
•- actual H. pylori infection, or H. pylori infection treated in in the last 3 months
•- known allergies against proton pump inhibitors and/or H2-receptorantagonists
•- continuous intake of systemic or local acting drugs with interaction potential related
•to the study drug (CYP2C19 or CYP3A4) (Anlage K) in the last 4 weeks prior the study,
•exception is permitted for single dose administration until 48 hours prior the study
•- alcohol consumption (more than 40 g/day, 2 bottles beer), nicotine consumption
•(more than 3 cigarettes/day)
•- participation in other clinical studies within the last 3 months
•- donation of blood within the last 8 weeks prior the study
•- serious diseases of the patient (e.g. diseases of central nervous system, psychiatric
•diseases or acute infections) if they are contrary to the inclusion criteria
•- pregnancy

发起方

Medical Faculty, Otto-von-Guericke University