NCT01973790已完成3 期
A Phase III, Multicentre, Single-arm, Open-label Study to Evaluate the Long-term Safety of Z-338 in Subjects With Functional Dyspepsia
Zeria Pharmaceutical6 个研究点 分布在 4 个国家目标入组 207 人开始时间: 2014年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 207
- 试验地点
- 6
- 主要终点
- General safety endpoints
研究概览
简要总结
The primary objective of this study is to evaluate the long-term safety of 100 mg Z-338 TID in European subjects with FD.
详细描述
This is a Phase III, multicentre, single-arm, open-label study to evaluate the long-term safety of 100 mg Z-338 TID in subjects with FD.
The study comprises a screening period (up to 3 weeks), a run-in period (1 week) and an open-label treatment period (52 weeks). Including an additional 2-week follow-up period for assessment of AEs, the maximum duration of a subject's participation in the study will be 58 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects to provide written informed consent prior to any study procedures being performed
- •Subjects with a diagnosis of FD (postprandial distress syndrome) as defined by the Rome III Criteria
- •Subjects must present Postprandial Fullness or Early Satiation as the most bothersome symptom during the 6 months prior to informed consent.
- •Subjects must have a normal endoscopy result within the 6 months (3 months in case of subjects who are Helicobacter pylori positive) prior to informed consent or during the screening period.
排除标准
- •Subjects on PPI(s) who are unable to discontinue PPI medication by the end of the screening period
- •Subjects taking drugs that affect gut motility, gut sensitivity and/or acid secretion who are unable to discontinue these drugs by the end of the screening period
- •Subjects who have received H. pylori eradication therapy during the 3 months prior to informed consent
- •Subjects with confirmed organic gastrointestinal disease
- •Subjects presenting with predominant complaints relieved by stool movements (irritable bowel syndrome)
- •Subjects presenting with predominant GORD symptoms
- •Subjects presenting with predominant complaints of chronic idiopathic nausea
- •Subjects with Type I or Type II diabetes
- •Subjects with body mass index (BMI) over 30 kg/m2
- •Subjects with any condition which, in the opinion of the Investigator, makes the subject unsuitable for entry into the study
研究组 & 干预措施
Z-338
Experimental
100mg TID
干预措施: Z-338 (Drug)
结局指标
主要结局
General safety endpoints
时间窗: up to 58 weeks
Adverse Events, 12-lead ECGs, Laboratory variables, Vital signs, Physical examination
次要结局
- To explore the efficacy(up to 52 weeks)
研究者
研究点 (6)
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