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临床试验/NCT03076411
NCT03076411已完成不适用

A Non-interventional, Observational Study With a Fixed Combination of Pepsin and Amino Acid Hydrochloride in Patients With Functional Dyspepsia

Nordmark Arzneimittel GmbH & Co. KG1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2012年1月11日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
97
试验地点
1
主要终点
Gastrointestinal Symptom Score (GIS)

研究概览

简要总结

This non-interventional, observational study investigates the course of symptoms in patients with functional dyspepsia under treatment with a fixed combination of pepsin and amino acid hydrochloride over a period of approximately 6 weeks. The change of the Gastrointestinal Symptom Score (GIS©) was the primary parameter for the assessment of efficacy and was performed at baseline, after 3 and 6 weeks of treatment respectively. Safety measures included recording of AEs and physical examination as well as measurement of vital signs. The aim was to observe 100 patients during the course of this non-interventional study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with dyspepsia
  • Women and men aged between 18 and 75

排除标准

  • Unwilling to consent

结局指标

主要结局

Gastrointestinal Symptom Score (GIS)

时间窗: 6 weeks

This is a third party assessment form.

次要结局

  • Symptomatology(6 weeks)
  • Tolerability assessed by Adverse Events(6 weeks)
  • Subjective assessment of efficacy (4 point Likert scale)(6 weeks)
  • Subjective assessment of feasibility of use (4 point Likert scale)(6 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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