Symptomatic Gastroesophageal Reflux Disease: Double Blind Randomized Controlled Study of On-demand Therapy Versus Maintenance Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 244
- 试验地点
- 1
- 主要终点
- Treatment failure
研究概览
简要总结
Maintenance treatment with proton pump inhibitor (PPI) is the most widely recommended modality of treatment for long-term management of gastroesophageal reflux disease (GERD). Yet in clinical practice treatment is commonly given in short courses on as required basis during symptom flare up, particularly for patients with mild to moderate GERD.
On-demand therapy also has the potential advantage that patient does not need to take regular medications, thereby improving the quality of life. However, whether on-demand PPI therapy achieves similar efficacy of symptom control is uncertain.
The aim of this study is to compare the efficacy and quality of life of on-demand and maintenance PPI regimens in long-term management of non-erosive GERD patients. The investigators hypothesize that on-demand PPI treatment is as effective as maintenance PPI.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weekly symptoms of heartburn or acid regurgitation of moderate severity as predominant complaint for at least 6 months
排除标准
- •Erosive esophagitis
- •Concomitant peptic ulcer disease
- •Use of NSAID in recent 4 weeks (Low dose aspirin < 300 mg is allowed)
- •Pregnant or lactating female
- •Illiterate patient (who cannot administer questionnaire)
- •Known hypersensitivity to PPI
结局指标
主要结局
Treatment failure
时间窗: 26 Weeks
次要结局
- Symptom score(26 weeks)
- Quality of Life(1 year)
- Number of days off treatment