The Rates of Complete Symptom Relief,Prevetion of Symptom Relapse and Maintenance of Esophagitis Healing for 4-week Versus 8-week Esomeprazole Therapy Among Los Angeles Grades A and B Erosive Esophagitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 408
- 试验地点
- 1
- 主要终点
- The Rates of Complete Symptom Relief
研究概览
简要总结
To investigate the impact of initial treatment duration (4-week versus 8-week)of Esomeprazole (40mg) on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis
详细描述
Patients:
Patients between the ages of 15 and 80 years with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach, who have Los Angeles Grade A and B erosive esophagitis proven by endoscopy are recruited. Criteria for exclusions include (1) coexistence of peptic ulcer or gastrointestinal malignancies, (2) pregnancy, (3) coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia), (4) previous gastric surgery, (5) allergy to esomeprazole, (6) symptom score of a validated questionnaire (Chinese GERDQ) less than 12, and (7) equivocal endoscopic diagnosis of Los Angeles Grade A and B erosive esophagitis.
Outcome parameters:
The main outcome measures
- Rate of complete symptom relief (CSR) at the end of initial treatment phase
- rate of symptom relapse within 12 weeks after stopping initial therapy
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
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients between the ages of 15 and 80 years
- •with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach,
- •who have Los Angeles Grade A and B erosive esophagitis proven by endoscopy are recruited.
排除标准
- •coexistence of peptic ulcer or gastrointestinal malignancies,
- •coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia),
- •previous gastric surgery,
- •allergy to esomeprazole,
- •symptom score of a validated questionnaire (Chinese GERDQ) less than 12, and
- •equivocal endoscopic diagnosis of Los Angeles Grade A and B erosive esophagitis.
研究组 & 干预措施
GERD Los Angeles A and B-4 week group
Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily- 4 week group
干预措施: Esomeprazole 40 mg (Drug)
GERD Los Angeles A and B-8-week group
Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily- 8 week group
干预措施: Esomeprazole 40 mg (Drug)
结局指标
主要结局
The Rates of Complete Symptom Relief
时间窗: at the 20 weeks after the end of initial treatment.
Rate of complete symptom relief (CSR) at the end of initial treatment phase
次要结局
未报告次要终点
研究者
Wei-Chen Tai M.D.
Attending physician
Chang Gung Memorial Hospital