A Phase III, Multicenter, Open Label, Extension Study to Evaluate the Long-Term Safety of Renzapride 4 mg Once Daily in Women With Constipation-Predominant Irritable Bowel Syndrome (IBS-C)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 939
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
The main purpose of this study is to evaluate the long-term safety and tolerability of renzapride at a dose of 4 mg taken once daily for 12 months in women with constipation-predominant irritable bowel syndrome (IBS-C).
详细描述
Since IBS is a chronic condition affecting patients over many years, it is anticipated that renzapride will be prescribed and used by patients on a daily basis for long periods of time. Hence the need to understand its long-term safety and tolerability in the target population. This study is open label and so all subjects will take renzapride and will know that they are taking it. Enrolment in to this study is restricted to subjects completing a 12-week, placebo-controlled study of the effectiveness of renzapride in providing relief from IBS-C (Study no. ATL1251/038/CL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •completed 12 weeks treatment in the preceding pivotal study ATL1251/038/CL
排除标准
- •Subjects who are pregnant or breastfeeding
研究组 & 干预措施
1
All subjects take two capsules (2x renzapride 2 mg) daily, from the day of enrolment until the scheduled visit at the end of Week 52
干预措施: Renzapride (Drug)
结局指标
主要结局
Adverse events
时间窗: One year
次要结局
- Vital signs, routine clinical laboratory data, 12-lead ECG(One year)