Research of Efficient Use of Omeprazole in Combination With Domperidone in Gastroesophageal Reflux Disease of Mild to Moderate Severity
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- change severity of heartburn after 8 weeks of treatment with Omez-DSR preparation in comparison with OMEZ preparation
研究概览
简要总结
The purpose of this study is to determine the efficacy, safety, and tolerability of omeprazole in combination with domperidone in GERD treatment for subsequent efficient pharmacotherapy of GERD.
Objectives of the trial To assess the efficacy of omeprazole in combination with domperidone regarding change of incidence and severity of clinical symptoms of GERD during 8 weeks of treatment To compare the efficacy of omeprazole in combination with domperidone regarding change of incidence and severity of clinical symptoms of GERD during 8 weeks of treatment To assess the efficacy of omeprazole in combination with domperidone regarding change of incidence and severity of endoscopic symptoms of GERD during 8 weeks of treatment To compare the efficacy of omeprazole in combination with domperidone regarding change of incidence and severity of endoscopic symptoms of GERD during 8 weeks of treatment To determine the efficiency and advantages of one GERD therapy considering efficacy, safety, and individual variance of patients' reactions
详细描述
Study design . Primary and secondary endpoints
Primary endpoint:
• reduced incidence and severity of heartburn after 8 weeks of treatment with Omez-DSR preparation in comparison with OMEZ preparation.
Secondary endpoints:
- reduced severity of heartburn estimated against visual analog scale after 8 weeks of treatment;
- incidence of events of heartburn after 4 and 8 weeks of treatment;
- proportion of patients with completely jugulated heartburn at the 4th and 8th weeks of treatment;
- number of days without heartburn after 4 weeks of treatment;
- proportion of patients with resolved esophagitis after 8 weeks of treatment in subjects with esophagitis at the time of enrollment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
omeprazole+domperidone SR
patients with GERD receive omeprazole 20mg + domperidone SR 30mg , 2 capsules in the morning
干预措施: omeprazole (Drug)
omeprazole
omeprazole 40mg in the morning
干预措施: omeprazole+domperidone SR (Drug)
结局指标
主要结局
change severity of heartburn after 8 weeks of treatment with Omez-DSR preparation in comparison with OMEZ preparation
时间窗: change from baseline severity of heartburn at 8 weeks
questionnaire
change incidence of heartburn after 8 weeks of treatment with Omez-DSR preparation in comparison with OMEZ preparation
时间窗: change from baseline incidence of heartburn after 8 weeks of treatment
questionnaire
次要结局
- number of days without heartburn(4 weeks of treatment)
- proportion of patients with completely jugulated heartburn(4 and 8 weeks of treatment)
- proportion of patients with resolved esophagitis(after 8 weeks of treatment)