跳至主要内容
临床试验/NCT00673972
NCT00673972撤回4 期

A Comparative Study of Epigastric Pain Syndrome and Postprandial Distress Syndrome in Personality, Helicobacter Pylori Infection, Gastric Emptying and Response to Lansoprazole Treatment

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2008年4月最近更新:
适应症

试验速览

阶段
4 期
状态
撤回
入组人数
80
试验地点
2
主要终点
Primary end point of the study is to compare the gastric emptying time in epigastric pain syndrome and that in postprandial distress syndrome

研究概览

简要总结

The purpose of this study is to compare postprandial distress syndrome and epigastric pain syndrome in demographics psychological features, infection of Helicobacter pylori, gastric emptying and therapeutic response to lansoprazole.

详细描述

Functional dyspepsia is a common clinical disorder with significant impact on quality of life and with enormous social cost. Previous studies have revealed that functional dyspepsia is not a homogenous disease but a heterogenous symptom complex. Because of heterogeneity in etiology and pathogenesis, no specific treatment is appropriate for all patients with functional dyspepsia. Currently available treatments demonstrated efficacy only in subsets of patients.

Appropriate subgrouping of functional dyspepsia, which categorizes more homogenous patients into the same group, will correlate better with specific etiologic factors and pathogenetic mechanisms. Consequently patients may have appropriate specific treatment based on more directed pathologenesis and subgrouping. To this end, American Gastroenterology Association launched new edition of clinical guide for functional gastrointestinal disorder, the Rome III in May 2006. The new diagnostic criteria of Rome III de-emphasized functional dyspepsia as an entity and recommended sub-classification into two conditions: postprandial distress syndrome and epigastric pain syndrome. However whether this new diagnostic criteria and systems are effective and clinically relevant remains unknown.

Aims:

We aim to compare postprandial distress syndrome and epigastric pain syndrome in demographics psychological features, infection of Helicobacter pylori, gastric emptying and therapeutic response to lansoprazole.

研究设计

研究类型
Interventional
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • aged greater than 20 years
  • fulfill Rome III diagnostic criteria

排除标准

  • children and teenagers aged less than 20 years
  • Organic lesions such as ulcers, tumors, bleeding, vasculopathy or esophagitis as demonstrated on upper endoscopy
  • concurrent illness with malignancy, diabetes mellitus, liver cirrhosis, renal failure or porphyria
  • diagnosis of organic disease for dyspeptic symptoms by treating physicians
  • history of abdominal surgery
  • concurrent user of aspirin and NSAID
  • history of allergy or severe side effects to lansoparzole
  • pregnant or lactating women

结局指标

主要结局

Primary end point of the study is to compare the gastric emptying time in epigastric pain syndrome and that in postprandial distress syndrome

时间窗: After four-week treatment of lansoprazole

次要结局

  • Psychiatric distress, personality traits, infection of H. pylori and symptom improvement to lansoprazole(after four-week treatment of lansoprazole)

研究者

申办方类型
Other

研究点 (2)

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