NCT01378338已完成不适用
Recurrence Rate, Risk Factors for the Recurrence, and Quality of Life in Patients With GERD in Korea-an Observational Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 855
- 试验地点
- 1
- 主要终点
- Rate of recurrence after treatment with PPI in patients with GERD
研究概览
简要总结
Recurrence rate, risk factors for the recurrence, and quality of life in patients with GERD in Korea-an observational study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both ERD or NERD patient who confirmed by EGD findings within 12 months prior to V1 and have a symptom with moderate or more, at least once per week within 1 week prior to V1 and Patients between age 20 and 80with typical reflux symptoms
- •Among the patient who have not taken PPI or H2 blocker within 4 weeks prior to V1, needs to be prescribed PPIs 4~8 weeks as a part of the routine clinical practice due to typical symptom
- •Patients who give the signed informed consent
排除标准
- •Patients with past history of gastrointestinal surgery
- •Patients with known malignancy or history of such diseases
- •Patients with moderate to severe general medical conditions like ischemic heart disease, chronic renal failure, congestive heart failure, COPD, liver cirrhosis, acute or chronic pancreatitis, or other medical conditions which the investigator considers
结局指标
主要结局
Rate of recurrence after treatment with PPI in patients with GERD
时间窗: 12month
Response rate to the treatment with PPI in patients with GERD
时间窗: 12month
次要结局
- Baseline characteristics related to the recurrence of GERD(12month)
- Rate of complete resolution in each group of patients with ERD or NERD(12month)
- Quality of life measured by EQ-5D and WPAI-GERD in each group of patients with ERD or NERD(12month)
- Rate of recurrence in each group of patients with ERD or NERD(12month)
研究者
研究点 (1)
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