NCT00510484已完成3 期
A Double-blind, Randomized, Multi-center, Placebo-controlled, Cross-over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 24,000 Unit Capsules in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 23
- 主要终点
- Coefficient of Fat Absorption (%)
研究概览
简要总结
This study will assess the effect of pancrelipase delayed release 24,000 unit capsules on fat and nitrogen absorption in subjects with PEI due to Cystic Fibrosis.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed CF diagnosis by two positive chloride sweat tests or gene analysis
- •Confirmed PEI by historical CFA < 70% without supplementation or current or historical fecal elastase < 50µg/g stool (within the last 12 months)
- •Subjects of 12 years or older
- •Currently receiving treatment with a commercially available pancreatic enzyme product on a stable dose for more than 3 months
- •Clinically stable condition without evidence of acute respiratory disease or any other acute condition
- •Females of child-bearing potential must agree to continue using a medically acceptable method of birth control
排除标准
- •Ileus or acute abdomen
- •History of fibrosing colonopathy
- •History of distal ileal obstruction syndrome within 6 months of enrollment
- •Use of an immunosuppressive drug
- •Any type of malignancy involving the digestive tract in the last 5 years
- •Known infection with HIV
研究组 & 干预措施
A
Experimental
干预措施: Pancrelipase Delayed Release (Drug)
B
Placebo Comparator
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Coefficient of Fat Absorption (%)
时间窗: 5 days
This coefficient is calculated from fat intake and fat excretion : 100\*\[fat intake-fat excretion\]/fat intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.
次要结局
- Coefficient of Nitrogen Absorption (%)(5 days)
- Total Fat Excretion (Grams)(5 days)
- Total Stool Weight (Grams)(5 days)
- Stool Frequency(5 days)
- Percentage of Days With no Flatulence.(5 days)
- Percentage of Days With no Abdominal Pain.(5 days)
研究者
研究点 (23)
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