NCT02137382已完成3 期
A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ≥ 12 Years of Age 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
- 发起方
- Abbott
- 入组人数
- 41
- 试验地点
- 7
- 主要终点
- Coefficient of Fat Absorption (CFA)
研究概览
简要总结
maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in Cystic Fibrosis
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
- •Signed informed consent given by the subject, or the parents, or a legally acceptable representative. If required by the Institutional Review Board/Ethics Committee (IRB/IEC), assent will be given by the subject
- •Age ≥ 12 years
- •Subjects who are able to swallow capsules with each meal and snacks
- •Diagnosis of Cystic Fibrosis (CF) confirmed by two positive chloride sweat tests or gene analysis
- •Diagnosis of pancreatic exocrine insufficiency proven by:
- •Coefficient of fat absorption (CFA) < 70% without supplementation
- •or Human fecal elastase < 50 μg/g stool
- •Currently receiving treatment with a commercially available pancreatic enzyme product and on a continuous dose of this product for more than 3 months
- •Clinically stable condition without evidence of acute respiratory disease within 1 month of enrollment
- •Stable body weight defined as no more than a 5% decline within 3 months of enrolment
- •Females of child-bearing potential should agree to continue using a medically acceptable method of birth control throughout the study and for 30 days immediately after the last dose of study drug. Medically acceptable methods of birth control include bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection (Depo-Provera™), an intrauterine device, or an oral contraceptive taken within the past 3 months where the subject agrees to continue using during the study or to adopt another birth control method, or a double-barrier method which consists of a combination of any two of the following: diaphragm, cervical cap, condom, or spermicide.
排除标准
- •Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic (except underlying disease), hematologic/immunologic, head, ears, eyes, nose, throat, dermatologic/connective tissue, musculoskeletal, metabolic/nutritional (except underlying disease), endocrine (except diabetes mellitus), neurologic/psychiatric, allergy, recent major surgery, or other relevant diseases as revealed by history, physical examination and/or laboratory assessments, which could limit participation in or completion of the study
- •History of acute abdomen
- •History of fibrosing colonopathy
- •History of distal intestinal obstruction syndrome (DIOS) within 6 months prior to enrollment
- •Solid organ transplant or surgery affecting the large bowel other than appendectomy
- •Small bowel surgery that significantly affected absorptive capacity (e.g. gastrectomy or pancreatectomy)
- •Pregnancy or lactation
- •Any type of malignancy involving the digestive tract in the last 5 years
- •Celiac disease or Crohn's disease
- •Known allergy to pancreatin or inactive ingredients (excipients) of pancreatin capsules
- •Suspected non-compliance or non-cooperation
- •Intake of experimental drugs within 30 days prior to study start
- •Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subject's participation in or ability to complete the study
- •Diagnosis of human immunodeficiency virus in medical history.
研究组 & 干预措施
Creon N, then Creon®
Experimental
Subjects first received Creon N for 5 days. After a washout period of 3 to 14 days, they received Creon® for 5 days. The Investigator calculated the total number of capsules per day needed to treat the subject with 8000 to <10000 lipase units per kg body weight and day, Capsules of both Creon N and Creon® contain 25000 lipase units.
干预措施: Creon® (Drug)
Creon® , then Creon N
Experimental
Subjects first received Creon® for 5 days. After a washout period of 3 to 14 days, they received Creon N for 5 days. The Investigator calculated the total number of capsules per day needed to treat the subject with 8000 to <10000 lipase units per kg body weight and day, Capsules of both Creon N and Creon® contain 25000 lipase units.
干预措施: Creon N (Drug)
结局指标
主要结局
Coefficient of Fat Absorption (CFA)
时间窗: 5 days
CFA is calculated from fat intake and fat excretion, according to the formula: CFA (%) = 100 \[fat intake - fat excretion\] / fat intake
次要结局
- Coefficient of Nitrogen Absorption (CNA).(5 days)
- Total Fat Excretion(5 days)
- Stool Frequency(5 days)
- Percentage of Days With no Flatulence(5 days)
- Percentage of Days With no Abdominal Pain(5 days)
- Percentage of Days With Formed/Normal Stools(5 days)
研究者
研究点 (7)
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