NCT01896583已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety and Tolerability, of ASP7147 in Patients With Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 13
- 主要终点
- Abdominal pain
研究概览
简要总结
This trial will evaluate the effect of ASP7147 on daily abdominal pain due to IBS-D during 4 weeks of treatment. It will also evaluate safety and tolerability in patients with IBS-D over the 4-week treatment period.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written informed consent
- •Men or women aged 18-75 years
- •Patient has IBS with diarrhea (IBS-D)
- •Ability to communicate with the investigator
排除标准
- •IBS with constipation (IBS-C) or mixed IBS (IBS-M)
- •Other significant disease or condition that may interfere with trial completion
- •Untreated lactose intolerance
- •History of alcohol or drug abuse in past two years
- •Participation in other clinical trials within prior month
研究组 & 干预措施
ASP7147
Experimental
ASP7147, 300 mg, tablet, twice per day for 4 weeks oral
干预措施: ASP7147 (Drug)
Placebo
Placebo Comparator
oral
干预措施: Placebo (Drug)
结局指标
主要结局
Abdominal pain
时间窗: 4 weeks
10-point pain scale
次要结局
- Stool consistency(4 weeks)
- Stool frequency(4 weeks)
研究者
研究点 (13)
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