EUCTR2009-012842-21-GB进行中（未招募）1 期
Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover, Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. 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 quantitative pilocarpine iontophoresis;
- •2. Pancreatic insufficiency documented by a monoclonal faecal elastase
- •<=100 µg/g stool at screening (test results within the previous 24 months are acceptable);
- •3. Currently receiving pancreatic enzyme replacement therapy;
- •4. 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;
- •5. 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;
- •6. Subjects likely to adhere to a prescribed diet, vitamin, and nutritional supplements usage;
- •7. Dose stabilisation, defined as no change in the number of capsules taken per day for 3 consecutive days before the end of the Screening Period;
- •8. Willing to be switched from existing pancreatic enzyme treatment;
- •9. Women of childbearing potential must use a medically acceptable birth control method for the duration of the study (ie, from screening) and for 30 days thereafter;
- •- Women who are not of childbearing potential will be defined as no attainment of menses, confirmed sterility, undergone surgical procedure (TAH and or oophorectomy), or have undergone menopause (12 consecutive months without menses and substantiated by an appropriate follicle stimulating hormone [FSH]/ luteinizing hormone [LH] test for subjects under 65 years of age);
- •10. Written informed consent obtained; and
- •11. Appropriate assent from the minor if consent is provided by parent/guardian according to national legal requirements.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 43
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 43
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Age <12 years;
- •2. Known contraindication, hypersensitivity, or intolerance to pork or other porcine PEPs;
- •3. Current uncontrolled diabetes mellitus;
- •4. History of solid organ transplantation;
- •5. History of surgery affecting the bowel function and weight gain;
- •6. History or presence of fibrosing colonopathy;
- •7. History of any other clinically significant cardiac, renal, neurological, gastrointestinal, hepatic, or endocrine disease, with sequelae and/or treatment requirements that could interfere with the results of the study;
- •8. Presence of hepatic insufficiency that in the opinion of the investigator could interfere with the conduct of the study.
- •9. Any acute respiratory infection in the previous 7 days requiring antibiotics;
- •10. Cancer or any other chronic disease with life expectancy <2 years;
- •11. Subjects treated with oral steroids in the last 8 weeks;
- •12. Subjects receiving nutritional supplements containing high doses (- 30%) of medium-chain triglycerides (MCTs) to maintain weight gain;
- •13. Subjects who, in the opinion of the investigator, have a significant medical and/or mental disease that would compromise the subject’s welfare, pose an unacceptable risk to him/her, or confound the study results;
- •14. Subjects with evidence of alcohol or drug abuse that, in the opinion of the investigator, could lead to noncompliance with study requirements, or subjects otherwise unable to understand the nature, scope, and possible consequences of the study;
- •15. Positive urine (dipstick) pregnancy test (for subjects of childbearing potential);
- •16. Pregnant or lactating women;
- •17. Subjects who have been previously enrolled in this study;
- •18. Participation in an interventional clinical study within 30 days of the screening visit or as applicable per specific country regulations/guidelines. Participation in observational studies is not an exclusion;
- •19. Presence of any condition known to increase faecal fat loss including but not limited to: celiac disease, Crohn’s disease, tropical sprue, bacterial bowel infection, liver disease, lactose intolerance, pseudomembranous colitis, biliary and pancreatic cancer, radiation enteritis, Whipple’s disease;
- •20. Presence of any uncontrolled condition known to increase faecal fat loss including celiac disease, Crohn's disease and lactose intolerance.
- •21. Subjects who require chronic treatment with narcotics; or
- •22. Subjects who cannot swallow size 00 capsules.
研究者
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