NCT02078856已完成2 期
A Phase II, Placebo-controlled, Multi-centre, Dose-finding Efficacy and Safety Study of a Range of Doses of A3384 in Patients With Bile Acid Malabsorption (BAM)/Bile Acid Diarrhoea (BAD)
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
- 19
- 试验地点
- 3
- 主要终点
- The primary efficacy objective of this study is to demonstrate the efficacy of different daily doses of A3384 as determined by the # of bowel movements (BMs).
研究概览
简要总结
The purpose of this trial is to determine the efficacy and safety of A3384 administered to patients with Bile Acid Malabsorption (BAM)/Bile Acid Diarrhoea (BAD).
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
- 18 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 Bile Acid Malabsorption/Bile Acid Diarrhoea
- •Patient has successfully completed study requirements with no clinically relevant findings for physical exam, ECG, laboratory tests 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 needs medications prohibited as specified in the protocol
研究组 & 干预措施
A3384 High dose
Experimental
Administered twice daily for the duration of the study
干预措施: A3384 (Drug)
A3384 Low dose
Experimental
Administered twice daily for the duration of the study
干预措施: A3384 (Drug)
Placebo
Placebo Comparator
Administered twice daily for the duration of the study
干预措施: A3384 (Drug)
结局指标
主要结局
The primary efficacy objective of this study is to demonstrate the efficacy of different daily doses of A3384 as determined by the # of bowel movements (BMs).
时间窗: 2 weeks
次要结局
- Secondary efficacy objectives of this study are to demonstrate the efficacy of different daily doses on other BM parameters and BAM/BAD symptoms(Baseline and 2 weeks)
研究者
研究点 (3)
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