A Multicenter, Randomized, Open-label Phase IV Study Exploring Symptom Control Rate in Co-diagnosed NERD and Chronic Gastritis Patients Treated With 8 Weeks Esomeprazole Treatment Regimen and 2 Weeks Esomeprazole Treatment Regimen
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 305
- 试验地点
- 1
- 主要终点
- Symptom Control Rate at 24 Weeks Assessed by Gerd Q Questionnaire.
研究概览
简要总结
To compare the symptom control rate between 8 weeks esomeprazole treatment regimen group and 2 weeks esomeprazole treatment regimen group in co-diagnosed NERD and chronic gastritis patients, as evaluated by GerdQ after 24 weeks maintenance treatment/follow up.
详细描述
A multicenter, randomized, open-label Phase IV study exploring symptom control rate in co-diagnosed NERD and chronic gastritis patients treated with 8 weeks esomeprazole treatment regimen and 2 weeks esomeprazole treatment regimen.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heartburn and/or regurgitation symptoms last for at least 3 months
- •Endoscopic diagnosed as chronic gastritis (non-atrophic, and mild atrophic gastritis) within 2 weeks prior to randomization GerdQ score =8
排除标准
- •Endoscopic visible reflux esophagitis, esophageal varices, Barrett's esophagus, malignancy or peptic ulcer Patients with Hp positive result and are eager to take Hp eradication therapy will be excluded
- •If Hp positive, patients could take Hp eradication therapy after the study completion Previous PPI or H2RA therapy in the last 2 weeks before enrollment
研究组 & 干预措施
Esomeprazole 8 weeks treatment
20 mg q.d. (quaque die) once a day dosing for 8 weeks
干预措施: Esomeprazole (Drug)
Esomeprazole 2 Weeks Treatment
20 mg q.d. (quaque die) once a day dosing for 2 weeks
干预措施: Esomeprazole (Drug)
结局指标
主要结局
Symptom Control Rate at 24 Weeks Assessed by Gerd Q Questionnaire.
时间窗: 24 weeks
GerdQ Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. When GerdQ ≥8, the patients could be symptom based diagnosed as GERD. GerdQ was consisted of 3 categories: A, B and C. Each category has two questions with sum of score ranging from 0 to 6. Symptom controlled was defined as patients with all items ≤1 in A and C category of GerdQ.
次要结局
- The Success Rate in Whole Study Duration.(24 weeks after end of treatment)
- Time to First Relapse.(From baseline to 24 weeks after end of treatment)
- Symptom Relief Rate in 2 Treatment Regimens.(8 weeks for arm 1, 2 weeks for arm 2)
- Symptom Relief Rate After 2 Weeks and 8 Weeks in 8 Weeks Treatment Group.(2 and 8 weeks)
- Number of Patients With Unscheduled Hospital Visit(s)(from baseline to week 24 after end of treatment)
- Percentage of Patients Satisfaction(24 weeks after end of treatment)
- Symptom Control Rate at 8 Weeks Assessed by Gerd Q Questionnaire(8 weeks)
- Symptom Control Rate at 16 Weeks Assessed by Gerd Q Questionnaire(16 weeks)