NCT00333372已完成2 期
To Evaluate the Efficacy of Z-338 in Subjects With Functional Dyspepsia, Focusing on the Assessment of Subjective Symptoms
Zeria Pharmaceutical1 个研究点 分布在 1 个国家目标入组 440 人开始时间: 2006年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- General impression at last visit
研究概览
简要总结
To Evaluate the efficacy of Z-338 in subjects with Functional Dyspepsia, focusing on the assessment of subjective symptoms in order to further determine the optimal dosage and efficacy parameters for PhaseIII clinical trials.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Postprandial fullness, upper abdominal bloating and/or early satiety should be at least moderate for 2 days or more at the 7 days at Visit 1
- •upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiety, nausea, vomit and belching should be at least moderate for at least 2 symptoms for 2 days or more at the 7 days at Visit 1
排除标准
- •subjects taht heartburn should be the most bothersome symptom
- •Subjects presenting with primary complaints relieved by stool movements (IBS)
- •Subjects with diabetes by treatment
- •Subjects taht heartburn should be more than moderate
结局指标
主要结局
General impression at last visit
次要结局
- General impression at each week
- Individual symptom score
研究者
研究点 (1)
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