Role of Mosapride in Patients With Gastroesophageal Reflux Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Symptom improvement evaluated by frequent scale for the symptoms of gastroesophageal reflux disease (FSSG)
研究概览
简要总结
Gastroesophageal reflux disease (GERD) is a very common disease in the Western World. In Taiwan, this disease is increasing gradually because the investigators' eating style is closing to Western world.
Proton pump is the main drug for patients with GERD in the past two decades. Prokinetic agent is an important adjuvant to the therapy of GERD. This study aims to evaluate the role of prokinetic agent in the management of GERD.
详细描述
This is a randomized, double-blind, cross-over study. FSSG is obtained at the beginning, one month and two months of the study.
This study plans to enroll 100 patients with symptoms of GERD (acid regurgitation, belching, dysphagia). After receiving endoscopic examination, a frequent scale for the symptoms of gastroesophageal reflux disease (FSSG) is obtained from these patients. Fifty patients receive lansoprazole 30 mg once plus mosapride 5 mg tid daily in the first month; and lansoprazole 30 mg once plus placebo tid daily in the second month. Another fifty patients receive lansoprazole 30 mg once plus placebo tid daily in the first month; and lansoprazole 30 mg once plus mosapride 5 mg tid daily in the second month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 90 years old
- •Outpatients
- •Characteristic GERD symptoms: acid regurgitation, heart burn, or belching
- •Erosive esophagitis on upper digestive endoscopy, based on Los Angeles classification
排除标准
- •History of allergy to lansoprazole or mosapride
- •Pregnant or lactating women
- •Decompensated liver disease
- •Age under 18 and over 90 years-old
- •Lack of informed consent
研究组 & 干预措施
1
lansoprazole plus mosapride for the first month, and followed by lansoprazole plus placebo for the second month
干预措施: mosapride for the first month and placebo for the 2nd month (Drug)
2
lansoprazole plus placebo for the first month, and lansoprazole plus mosapride for the second month
干预措施: placebo for the first and mosapride for the second month (Drug)
结局指标
主要结局
Symptom improvement evaluated by frequent scale for the symptoms of gastroesophageal reflux disease (FSSG)
时间窗: before enrollment, one month after treatment, two months after treatment
次要结局
未报告次要终点