NCT00141960已完成2 期
YM1170 Phase 2/3 Study: A Double Blind, Placebo Controlled, Group-comparison Study in Patients With Non-erosive Gastroesophageal Reflux Disease
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 480
- 试验地点
- 7
- 主要终点
- Rate of days with no heart burn in the treatment period
研究概览
简要总结
Gastroesophageal reflux disease (GERD) considered to be associated with mucosal damages in the esophagus and heartburn, which may sometimes interfere with daily activities due likely to reflux of acid gastric contents. While most of the patients given the diagnosis of GERD do not exhibit endoscopically obvious impairment in esophageal mucous membrane, they have subjective symptoms of non-erosive GERD including heartburn. But no drug has been launched in Japan, which targets non-erosive GERD. This study will examine the efficacy and safety of famotidine in subjects with non-erosive GERD.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have heartburn with non-erosive gastroesophageal reflux disease.
排除标准
- •Patients have diseases which interfere with evaluation of the efficacy and safety in this study.
- •Patients are receiving and/or have received prior to the enrollment the treatment which interfere with evaluation of the efficacy and safety in this study.
- •Patients have severe cardiovascular, hepatic, renal and hematological disorders.
- •Patients are allergic to or have a history of drug allergy to H2RA.
- •Patients have or have a history of malignant tumors.
- •Patients are pregnant or a lactating mother.
- •Patients have participated in other clinical studies less than 12 weeks prior to submitting the informed consent.
结局指标
主要结局
Rate of days with no heart burn in the treatment period
次要结局
- Disappearance of heart burn
- Severity of heart burn
- Frequency of heart burn
- Patient's final global improvement rating
- Other symptoms (e.g.,reflux sensation of gastric fluid, discomfort of pharynges)
研究者
研究点 (7)
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