NCT01159119终止1 期
Single Center Randomized Single Blind Crossover Group Active Control Study to Evaluate Safety and Efficacy of EUR-1066 a Pancreatic Enzyme Product in Patients With Chronic Pancreatitis Exocrine Pancratic Insufficiency,Chronic Abdominal Pain
Forest Laboratories1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2010年8月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Comparing frequency and severity of pain
研究概览
简要总结
The purpose of this study is to evaluate two different treatments in subjects with chronic pancreatitis, exocrine pancreatic insufficiency and chronic abdominal pain.
详细描述
To evaluate two different preparations of a pancreatic enzyme in subjects with chronic pancreatitis, exocrine pancreatic insufficiency, and chronic abdominal pain.
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, Care Provider)
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
- •Diagnosis of Chronic Pancreatitis
- •Exocrine Pancreatic Insufficiency
- •Chronic abdominal pain
排除标准
- •Acute pancreatitis
- •Active alcohol consumption
- •Uncontrolled diabetes
研究组 & 干预措施
EUR-1066-A
Experimental
Treatment with Eur-1006-A.
干预措施: EUR-1066-A (Drug)
EUR-1066-B
Experimental
Treatment with Eur-1066-B
干预措施: EUR-1066-B (Drug)
Zenpep
Active Comparator
Control Group: Consist of treatment with Zenpep
干预措施: Zenpep (Drug)
结局指标
主要结局
Comparing frequency and severity of pain
时间窗: up to 84 days
Patient diary
次要结局
- Changes in fat malabsorption(up to 124 days)
研究者
研究点 (1)
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