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临床试验/NCT00247715
NCT00247715已完成不适用

Comparison of an Antacid/H2-Receptor Antagonist/Proton Pump Inhibitor Versus a Proton Pump Inhibitor/H2-Receptor Antagonist/Antacid Treatment Strategy for Patients With New Onset Dyspepsia in General Practice (The DIAMOND-Study)

Radboud University Medical Center3 个研究点 分布在 1 个国家目标入组 664 人开始时间: 2003年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
664
试验地点
3
主要终点
Cost-efficacy

研究概览

简要总结

The purpose of this study was to determine which treatment strategy, the step-up or the step-down treatment strategy, is the most cost-effective treatment for patients with new onset dyspepsia in primary care.

详细描述

Dyspepsia is very common in the population. On an annual basis, 20%-40% of the general population suffers from upper gastrointestinal symptoms. The prevalence of dyspepsia presenting in primary care is about 3%, on average 24% of these patients are referred for secondary care in the same year. In spite of consensus statements and guidelines, the most effective treatment strategy for managing dyspepsia in primary care remains to be determined. In 2000 the Health Council of the Netherlands published some advice for the Minister of Health, Welfare and Sport with special consideration to the most cost-effective strategies for the management of dyspepsia. The Health Counsel Committee agrees in general with the existing guidelines of the Dutch College of General Practitioners to start with empirical treatment. However, the committee concluded that more research is necessary for management of dyspepsia in primary care, especially in uninvestigated patients as most research has been conducted in patients with persistent dyspeptic symptoms referred for secondary care.

Comparison: In this study empirical treatment according to the existing guidelines of the Dutch College of General Practitioners (the step-up treatment strategy) is compared to a step-down treatment strategy. According to this step-down treatment strategy the patient begins treatment with a proton pomp inhibitor, which is an expensive acid-suppressor and is often prescribed by general practitioners.

Step-up strategy: Algeldrate-magnesium oxide, in case of persisting/relapsing symptoms continued with ranitidine, if necessary continued with pantoprazole.

Step-down strategy: Pantoprazole, in case of persisting or relapsing symptoms continued with ranitidine, if necessary continued with algeldrate-magnesium oxide.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • Presence of a new episode of dyspepsia, defined as episodic or persistent symptoms including abdominal pain or discomfort and which are, in the opinion of the general practitioner, referable to the upper gastrointestinal tract.
  • Over 18 years of age
  • Informed consent (written) given.

排除标准

  • Use of prescribed acid suppressive medication during 3 months before consult
  • Investigated by upper gastrointestinal endoscopy one year before inclusion
  • Malignancy
  • Contraindication to the study medication
  • Pregnancy
  • Alarming symptoms like weight loss, bleeding, and disturbed food passage
  • Patients with insufficient comprehension of the Dutch language

研究组 & 干预措施

Step-up

Other

Stepwise treatment:

  • step1: antacid (+placebo proton pump inhibitor)
  • step2: H2-receptor antagonist
  • step3: proton pump inhibitor (+ placebo antacid)

干预措施: algeldrate/magnesium oxide (Drug)

Step-up

Other

Stepwise treatment:

  • step1: antacid (+placebo proton pump inhibitor)
  • step2: H2-receptor antagonist
  • step3: proton pump inhibitor (+ placebo antacid)

干预措施: ranitidine (Drug)

Step-up

Other

Stepwise treatment:

  • step1: antacid (+placebo proton pump inhibitor)
  • step2: H2-receptor antagonist
  • step3: proton pump inhibitor (+ placebo antacid)

干预措施: pantoprazole (Drug)

step-down

Other

Stepwise treatment:

  • step1: proton pump inhibitor (+placebo antacid)
  • step2: H2-receptor antagonist
  • step3: antacid (+proton pump inhibitor)

干预措施: algeldrate/magnesium oxide (Drug)

step-down

Other

Stepwise treatment:

  • step1: proton pump inhibitor (+placebo antacid)
  • step2: H2-receptor antagonist
  • step3: antacid (+proton pump inhibitor)

干预措施: ranitidine (Drug)

step-down

Other

Stepwise treatment:

  • step1: proton pump inhibitor (+placebo antacid)
  • step2: H2-receptor antagonist
  • step3: antacid (+proton pump inhibitor)

干预措施: pantoprazole (Drug)

结局指标

主要结局

Cost-efficacy

时间窗: 6 months

次要结局

  • Severity of gastrointestinal symptoms(2 weeks, after each treatment steps, and 6 months)
  • Quality of life(2 weeks, after each treatment step, and 6 months)
  • Genetic and psychosocial determinants(baseline and 6 months)
  • Patient compliance after treatment(0 to 6 months)

研究者

申办方类型
Other

研究点 (3)

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