EUCTR2006-002346-11-DE进行中（未招募）1 期
Stereoselective pharmacokinetics and CYP2C19-genotyping as outcome predictors of an omeprazole 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: 2006年9月26日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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
- •- 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
排除标准
- •- therapy with proton pump inhibitors
- •- actual H. pylori infection, or H. pylori infection treated 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 (CYP 2C19 or CYP 3A4) (Anlage K) in the last 4 weeks prior the
- •study, exception is permitted for single dose administration until 48 hours prior the
- •- 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, chronic or acute infections) if they are contrary to the inclusion criteria
- •- pregnancy
研究者
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