NCT02079675已完成2 期
Multi-center, Randomized, Double Blinded, Parallel Group, Placebo-controlled, Phase II Trial to Assess the Efficacy and Safety of SKI3246 in Subjects With Non-Constipation Irritable Bowel Syndrome
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
- 279
- 试验地点
- 1
- 主要终点
- Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA)
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of different doses of SKI3246 compared with placebo in the treatment of patients with irritable bowel syndrome with non-constipation.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been diagnosed as non-constipation by ROME III.
- •Patients who voluntarily signed written informed consent may participate in the study.
排除标准
- •Pregnant or lactating female.
- •Patients with a history of inflammatory bowel disease.
- •Severe neurological or psychological disease
- •History of allergic reaction to the medications used in this study
- •Use of other investigational drugs within 30 days prior to the study.
- •Patients that investigators consider ineligible for this study
研究组 & 干预措施
SKI3246 Low Dose
Experimental
Intervention: Drug: SKI3246 Low Dose
干预措施: SKI3246 Low Dose (Drug)
SKI3246 High Dose
Experimental
Intervention: Drug: SKI3246 High Dose
干预措施: SKI3246 High Dose (Drug)
Placebo
Placebo Comparator
Intervention: Drug: Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA)
时间窗: 12 weeks
次要结局
- Patient satisfaction using 5- Likert Scale(4 weeks)
- Subject Self Reported Adequate Relief of Pain(4 weeks)
- Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey(12 weeks)
- Visual Analog Scale (VAS)(4 weeks)
研究者
研究点 (1)
Loading locations...
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