NCT01641393已完成3 期
A Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover, Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in the Treatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis
Forest Laboratories37 个研究点 分布在 7 个国家目标入组 96 人开始时间: 2012年6月最近更新:
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
- 入组人数
- 96
- 试验地点
- 37
- 主要终点
- Coefficient of Fat Absorption over 72 hours (CFA-72h)
研究概览
简要总结
The purpose of the study is to further evaluate the safety and efficacy of EUR-1008 as compared to Kreon® in the treatment of exocrine pancreatic insufficiency associated with Cystic Fibrosis in subjects 12 years of age and older.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Definitive diagnosis of CF based on the following:
- •One clinical feature consistent with CF and
- •Either a genotype with 2 identifiable mutations known to cause CF or a sweat chloride concentration >60 mEq/L by pilocarpine iontophoresis
- •Pancreatic insufficiency documented by a monoclonal faecal elastase (FE) 100 μg/g stool at screening (test results within the previous 12 months are acceptable)
- •Currently receiving pancreatic enzyme replacement therapy
- •Adequate nutritional status based on the following: body mass index (BMI) >19 kg/m2 in adult subjects or a BMI percentile 10th percentile for age in adolescent (12 to 17 years age group) subjects
- •Are clinically stable with no evidence of concomitant illness or acute upper or lower respiratory tract infection that requires antibiotics during the 7-day interval prior to screening and preceding entry into this clinical study
排除标准
- •Age <12 years
- •Known contraindication, hypersensitivity, or intolerance to pork or other porcine PEPs
- •Current uncontrolled diabetes mellitus
- •History of solid organ transplantation
- •History of surgery affecting the bowel function and weight gain
研究组 & 干预措施
Kreon then EUR-1008
Experimental
- Kreon during Treatment Period 1 (29 days ±2 days) and
- EUR-1008 during Treatment Period 2 (29 days ±2 days).
干预措施: EUR-1008 25,000 Units (Drug)
EUR-1008 then Kreon
Experimental
- EUR-1008 during Treatment Period 1 (29 days ±2 days) and
- Kreon during Treatment Period 2 (29 days ±2 days).
干预措施: EUR-1008 25,000 Units (Drug)
EUR-1008 then Kreon
Experimental
- EUR-1008 during Treatment Period 1 (29 days ±2 days) and
- Kreon during Treatment Period 2 (29 days ±2 days).
干预措施: Kreon 25,000 Units (Drug)
Kreon then EUR-1008
Experimental
- Kreon during Treatment Period 1 (29 days ±2 days) and
- EUR-1008 during Treatment Period 2 (29 days ±2 days).
干预措施: Kreon 25,000 Units (Drug)
结局指标
主要结局
Coefficient of Fat Absorption over 72 hours (CFA-72h)
时间窗: 72 hours
During the last 72 hours of each treatment period, the CFA-72h will be calculated using fat intake data from the diet and fat excretion data from stools. Fat intake will be calculated by the dietician in collaboration with the study investigator using a validated tool.
次要结局
- Body weight(58 days.)
- Treatment Emergent Adverse Events(78 days)
- Coefficient of nitrogen absorption(72 hours)
- Vital signs(78 days)
- Control of signs and symptoms of EPI(2- 14 day periods)
- Impact on overall health, daily life, perceived well-being, and symptoms(58 days)
- Fat-soluble vitamins A, D, and E(58 days)
- Total cholesterol, calculated LDL-C, HDL-C(58 days)
- Standard safety laboratory tests(58 days)
研究者
研究点 (37)
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