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临床试验/NCT01824199
NCT01824199撤回早期 1 期

CYP2C19 Genotype as a Predictor of Gastric Acid Suppression and Healing of Erosive Esophagitis

Mayo Clinic1 个研究点 分布在 1 个国家开始时间: 2013年3月最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
撤回
发起方
Mayo Clinic
试验地点
1
主要终点
The correlation specific to CYP2C19 genotype with gastric acid suppression by omeprazole.

研究概览

简要总结

If CYP2C19 genotype can predict the efficacy of healing erosive esophagitis and gastric acid secretion in patients taking once a day omeprazole.

详细描述

Proton pump inhibitors are metabolized through the CYP2C19 hepatic enzyme system. Several variant genotypes of this enzyme exist which may lead to decreased, normal or increased metabolism of the proton pump inhibitor. With alteration of metabolism, the degree of gastric acid suppression achieved and efficacy in treating reflux could be affected. For example, Asian populations who have low activity of CYP2C19, commonly need lower doses of proton pump inhibitors to manage gastroesophageal reflux because of more sustained blood levels and availability of the drug. Theoretically, those patients who are rapid metabolizers would receive less effective treatment with proton pump inhibitors

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Omeprazole

Experimental

Patients will undergo whole blood testing for CYP2C19 genotype and will be started on omeprazole 40 mg once daily in the morning 30 minutes before breakfast. The Mayo Dysphasia Questionnaire 30 day (MDQ-30day) will be used during the study. At the end of 8 weeks, patients will undergo dual probe pH/impedance testing on therapy and a clinically indicated endoscopy to rule out Barrett's esophagus and assess healing. CYP2C19 genotyping will be performed in the Mayo laboratory.

干预措施: Omeprazole (Drug)

结局指标

主要结局

The correlation specific to CYP2C19 genotype with gastric acid suppression by omeprazole.

时间窗: 8 weeks

次要结局

  • To assess patients gastrointestinal symptoms, in patients with EoE by means of standard validated questionnaires(30 days)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

David A. Katzka

Principal Investigator

Mayo Clinic

研究点 (1)

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