NCT00623025终止3 期
Double-blind, Cross-over, Randomized, Placebo-controlled, Multi-center Study to Investigate the Effect of Creon®25 000 on the Coefficient of Fat Absorption of HIV-infected Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Abbott
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Coefficient of fat absorption (CFA)
研究概览
简要总结
The study investigates the effect of pancreatic enzymes on steatorrhea in HIV patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: Creon 25000 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Coefficient of fat absorption (CFA)
时间窗: After 2 weeks
次要结局
- Stool fat excretion(After 2 weeks)
- Normalization (yes, no) of stool fat excretion, i.e. < 7 g/day(After 2 weeks)
- Response (yes, no) with respect to stool fat excretion, i.e. improvement in stool fat excretion as compared to baseline(After 2 weeks)
- Stool weight(After 2 weeks)
研究者
研究点 (2)
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