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临床试验/NCT01536080
NCT01536080已完成不适用

Comparison of Risk Factors, GERD Symptoms and PPI Responses in the Reflux Esophagitis, Non-erosive Reflux Disease and Functional Heartburn Using GERD Impact Scale Questionnaire

Seoul National University Bundang Hospital1 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2008年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
207
试验地点
1
主要终点
The GIS score at baseline

研究概览

简要总结

Even the patients complain GERD symptoms such as heartburn and acid regurgitation the final diagnosis could be reflux esophagitis (RE), non-erosive reflux disease (NERD) and even functional heartburn (FH). In addition, the GERD symptoms are consisted of esophageal symptoms and extraesophageal symptoms. Thus it is necessary to use effective tool for the measurement of GERD symptoms and response of proton pump inhibitor in short time. Several questionnaires have been made for the assessment of GERD symptoms in recent years However, their screening tools do not include the impact of symptoms on everyday life and take a long time to complete the questionnaires. The GERD impact scale (GIS) questionnaire has been developed to compensate for this. It is a simple, one-page, questionnaire to communicate to the doctor the frequency of reflux symptoms and their effect on quality of life, recognizing that it might also prompt clinicians to make appropriate treatment for patients' symptoms. However, there was no report regarding comparison of the characteristics and response to PPI in RE, NERD and FH groups using GIS questionnaire so far.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
16 Years 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult Subjects (From 16 to 85 years old)
  • The subjects with GERD symptom who received 8 week PPI therapy

排除标准

  • Patients with a history of gastrointestinal surgery, Barrett's esophagus, esophageal motility disorder, duodenal ulcer, benign gastric ulcer or gastroduodenal cancer and systemic disease requiring chronic medication (except for hypertension and diabetes mellitus)
  • Patients who took H2 blocker or a PPI to relieve these symptoms within 4 weeks

结局指标

主要结局

The GIS score at baseline

时间窗: Before 8 weeks PPI treatment(baseline)

次要结局

  • Change of the GIS score from baseline(After 8 weeks PPI treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nayoung Kim

Professor, M.D.

Seoul National University Bundang Hospital

研究点 (1)

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