NCT00535756已完成4 期
One Week Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multi-Center Study With Creon® 25000 Minimicrospheres™ in Subjects With Pancreatic Exocrine Insufficiency After Pancreatic Surgery, Followed by an Open-Label Long-Term Extension of 1 Year
Abbott Products15 个研究点 分布在 4 个国家目标入组 58 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 15
- 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 will provide efficacy data for Creon 25000 MMS in PS patients as well as long-term safety data. During the long-term treatment with Creon 25000 nutritional parameters will be assessed and correlated with CFA
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
- 18 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
1
Experimental
干预措施: Creon (Drug)
2
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
- CNA, stool fat, stool weight, nutritional parameters, clinical symptomatology, SF-36, BMI(7 days after baseline, and end of open-label period (1 year of open label treatment))
研究者
研究点 (15)
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