China Survey of Proton Pump Inhibitor Empirical Treatment in Management of Outpatients With Gastroesophageal Reflux Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The overall responder rate
研究概览
简要总结
China Survey of Proton Pump Inhibitor Empirical Treatment in Management of Outpatients with Gastroesophageal Reflux Disease
详细描述
To estimate the overall responder rate after 4 weeks of Proton Pump Inhibitor empirical treatment This will be a multicenter prospective observational study carried out in China. Investigator will collect data in a pre-specified Case Report Form from the outpatient. Informed consents will be needed. Investigator will provide patient diary card to each patient for them to note down the symptom frequency every day. Main data from each outpatient will include demographics, Gerd Q, symptom frequency and Proton Pump Inhibitor empirical treatment. Data from each outpatient will be collected on the screening day, 2 weeks and 4 weeks.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male, and any race, Age ≥ 18 years and≤ 65 outpatients.
- •Gastroenterologists already prescribe PPI standard dose bid as empirical treatment.
- •The subject will not have endoscopy within 4 weeks after enrolment.
- •Ability to provide informed consent, adhere to the study visit schedule, and complete all study assessments and complete the patient diary by his/herself.
排除标准
- •If participating in any interventional clinical trial.
- •Patient with alarm symptom of oncology(weight loss, recurrent dysphagia, anemia, hematemesis, melena).
- •Continuous application of nonsteroidal anti-inflammation drugs or acid suppressive drug within 2 weeks before screening.
- •The need for H2-receptor antagonists (H2RA) including cimetidine, ranitidine and famotidine or sucralfate, antacids, traditional Chinese medicine and prokinetics during the upcoming 4 weeks (study duration).
- •Previous gastroesophageal surgery.
- •Upper gastrointestinal malignancy, achalasia, and esophageal spasm or stricture.
- •Peptic ulcer
- •Cerebral vascular disease
- •Zollinger-Ellison syndrome
- •Scleroderma
- •Hiatus hernia women
- •Pregnant or lactating women
- •Any other subjects were not suitable to this study in the opinion of the investigator.
结局指标
主要结局
The overall responder rate
时间窗: After 4 weeks of Proton Pump Inhibitor empirical treatment
The overall responder rate after 4 weeks of Proton Pump Inhibitor empirical treatment. Responder is defined as heartburn/regurgitation frequency ≤1 days during 7 days before evaluation visit, assessed using Gerd Q questionnaire at each post-baseline visit.
次要结局
- The overall responder rate(After 2 weeks of Proton Pump Inhibitor empirical treatment)
- The proportion of patients in each Gerd Q cut-off range at each visit(At each visit (baseline, 2 weeks and 4 weeks))
- The responder rate of different Proton Pump Inhibitor empirical treatment(After 2 and 4 weeks of different PPIs empirical treatment)
- The median time to response overall and for different Proton Pump Inhibitor, respectively(During 4 weeks of whole study)