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