Multi-center, Randomized, Double Blinded, Placebo-controlled, Phase II Trial to Assess the Efficacy and Safety of YKP10811 in Subjects With Irritable Bowel Syndrome With Constipation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 273
- 试验地点
- 1
- 主要终点
- Abdominal pain intensity & stool frequency responder
研究概览
简要总结
This trial is to investigate efficacy and safety of YKP10811 in Subjects With Irritable Bowel Syndrome With Constipation. The difference of responder rate between test group (10, 20 and 40mg) and placebo will be evaluated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •more than 18 years old
- •patients met with ROME III criteria for C-type IBS
排除标准
- •pregnancy or lactation
- •a history of surgery for gastrointestinal tract
- •a history of gastrointestinal bleeding, diverticulitis and ileus within 1 year of screening visit
- •inflammatory bowel disease or malignant tumor within 5 years of screening visit
- •taking drugs that could have impact on efficacy assessment
研究组 & 干预措施
Placebo
Two tablets of YKP10811 placebo are administered orally once a day for 12 weeks.
干预措施: YKP10811 placebo (Drug)
YKP10811 10mg
Two tablets of YKP10811 5mg are administered orally once a day for 12 weeks.
干预措施: YKP10811 5mg (Drug)
YKP10811 20mg
One tablet of YKP10811 20mg and one tablet of placebo are administered orally once a day for 12 weeks.
干预措施: YKP10811 20mg (Drug)
YKP10811 20mg
One tablet of YKP10811 20mg and one tablet of placebo are administered orally once a day for 12 weeks.
干预措施: YKP10811 placebo (Drug)
YKP10811 40mg
Two tablets of YKP10811 20mg are administered orally once a day for 12 weeks.
干预措施: YKP10811 20mg (Drug)
结局指标
主要结局
Abdominal pain intensity & stool frequency responder
时间窗: 12weeks
an improvement of equl and more than 30% from baseline in the average of the daily worst abdominal pain score and an increase of equal and more than 1 CSBM from baseline
次要结局
- subject global assessment(12 weeks)