NCT01007123已完成2 期
A Phase IIb, Double-blind, Randomised, Placebo-controlled, Multi-centre, Dose-finding Efficacy and Safety Study of a Range of Doses of Elobixibat in Patients With Chronic Idiopathic Constipation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Albireo
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Change From Baseline in Frequency of Spontaneous Bowel Movements
研究概览
简要总结
The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with chronic idiopathic 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient meets protocol specified criteria for constipation
- •Patient has successfully completed study requirements with no clinically relevant findings for physical exam, ECG, laboratory tests and colonoscopy as applicable
排除标准
- •Medical history or medical condition that would not make the patient a good candidate for the study or limit the patient´s ability to complete the study
- •Patient reports loose stools
- •Patient has IBS with pain/discomfort as predominant symptom
- •Patient needs medications prohibited as specified in the protocol
研究组 & 干预措施
A3309 low dose
Experimental
Administered once daily for the duration of the study
干预措施: A3309 (Drug)
A3309 intermediate dose
Experimental
Administered once daily for the duration of the study.
干预措施: A3309 (Drug)
A3309 high dose
Experimental
Administered once daily for the duration of the study
干预措施: A3309 (Drug)
Placebo
Placebo Comparator
Administered once daily for the duration of the study
干预措施: A3309 (Drug)
结局指标
主要结局
Change From Baseline in Frequency of Spontaneous Bowel Movements
时间窗: Baseline, weekly, up to 8 weeks
Primary ep W 1
次要结局
- Time to First Bowel Movement(First week)
- Stool Consistency Change From Baseline(Baseline, weekly and up to 8 weeks)
- LDL/HDL Ratio(Baseline and 8 weeks of treatment)
- Straining Change From Baseline(Baseline and during 8 weeks of treatment)
- Responder Analyses for Complete Spontaneous Bowel Movements (CSBMs)(Baseline, weekly and up to 8 weeks)
研究者
研究点 (1)
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