EUCTR2013-002819-10-ES进行中（未招募）不适用
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
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- 性别
- All
入选标准
- •1.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
- •2.Age ? 12 years
- •3.Subjects who are able to swallow capsules with each meal and snacks
- •4.Diagnosis of CF confirmed by two positive chloride sweat tests or gene analysis
- •5.Diagnosis of pancreatic exocrine insufficiency proven by:
- •a.CFA < 70% without supplementation
- •Human fecal elastase < 50 µg/g stool
- •6.Currently receiving treatment with a commercially available pancreatic enzyme product and on a continuous dose of this product for more than 3 months
- •7.Clinically stable condition without evidence of acute respiratory disease within 1 month of enrollment
- •8.Stable body weight defined as no more than a 5% decline within 3 months of enrolment
- •9.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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 19
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1.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
- •2.History of acute abdomen
- •3.History of fibrosing colonopathy
- •4.History of distal intestinal obstruction syndrome (DIOS) within 6 months prior to enrollment
- •5.Solid organ transplant or surgery affecting the large bowel other than appendectomy
- •6.Small bowel surgery that significantly affected absorptive capacity (e.g. gastrectomy or pancreatectomy)
- •7.Pregnancy or lactation
- •8.Any type of malignancy involving the digestive tract in the last 5 years
- •9.Celiac disease or Crohn?s disease
- •10.Known allergy to pancreatin or inactive ingredients (excipients) of pancreatin capsules
- •11.Suspected non-compliance or non-cooperation
- •12.Intake of experimental drugs within 30 days prior to study start
- •13.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
- •14.Diagnosis of human immunodeficiency virus in medical history.
研究者
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