NCT00400842已完成3 期
A Double-blind, Placebo-controlled, Parallel-group, Comparative Study to Confirm the Safety and Efficacy of Oral 1.5 g/Day and 3.0 g/Day of SA-001 in Patients With Pancreatic Exocrine Insufficiency Caused by Chronic Pancreatitis or by Pancreatectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 274
- 试验地点
- 98
- 主要终点
- Change in CFA from baseline to the end of double-blind treatment
研究概览
简要总结
This study is to verify the efficacy of 3.0 g/day of SA-001 in patients with pancreatic exocrine insufficiency caused by chronic pancreatitis in the non-compensatory stage or by pancreatectomy as compared with placebo under a double-blind design using the change in a coefficient of fat absorption as a primary endpoint.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
L
Experimental
干预措施: SA-001 (Drug)
H
Experimental
干预措施: SA-001 (Drug)
P
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in CFA from baseline to the end of double-blind treatment
时间窗: 7 days after baseline
次要结局
- Stool fat excretion, stool weight, stool frequency, nutritional parameters(7 days after baseline)
研究者
研究点 (98)
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