EUCTR2007-004004-12-BG进行中（未招募）不适用
A STUDY TO INVESTIGATE THE EFFECT OF PANCRELIPASE DELAYED RELEASE CAPSULES ON MALDIGESTION IN PATIENTS WITH EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMY
适应症
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
- 52
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
- •Signed Informed Consent
- •Age = 18 years
- •Chronic pancreatitis or pancreatectomy (total or partial)
- •- Chronic Pancreatitis must be proven (in medical history) by at least one of the following criteria:
- •- Imaging techniques (ultrasound, CT, MRI, or endoscopic ultrasound)
- •- ERCP (endoscopic retrograde cholangiopancreatography)
- •- Plain film of the abdomen with pancreatic calcification
- •- Histology
- •- Pancreatectomy must have occurred more than 180 days prior to enrollment
- •Pancreatic exocrine insufficiency has to be proven (in medical history) by either:
- •- pathological direct or indirect pancreatic function tests
- •- clinical signs of severe steatorrhea, e.g. loose bulky stools or visible stool fat, that resolved upon administration of pancreatic enzyme supplementation
- •- total pancreatectomy
- •Females of child-bearing potential must agree to continue using a medically acceptable method of birth control or agree to abstain from sexual intercourse (abstinence option only with agreement from the local IRB) throughout the study and for thirty days immediately after the last dose of study drug. Medically acceptable methods of birth control are defined as either a bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection (Depo-Provera?), an intrauterine device (IUD), or an oral contraceptive that has been taken for at least three months, which the subject agrees to continue using during the study, or a double-barrier method which must consist of a combination of any two of following: diaphragm, cervical cap, condom, or spermicide.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Evidence of severe cardiovascular, respiratory, urogenital, gastrointestinal/hepatic (except underlying disease), hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatologic/ connective tissue, musculoskeletal, metabolic/nutritional (except underlying disease), endocrine (except diabetes mellitus), neurologic / psychiatric, allergy, recent major surgery (excluding appendectomy and pancreatectomy for CP or abdominal surgery due to underlying disease or gall bladder removal), or other relevant diseases as revealed by history, physical examination and/or laboratory assessments which, might limit participation in or completion of the study.
- •- Ileus or acute abdomen
- •- Pregnant or lactating females.
- •- Any type of malignancy involving the digestive tract in the last 5 years except pancreatic cancer
- •- Any type of malignancy not in remission
- •- Celiac disease, isolated gastrectomy, Crohn´s disease and small bowel surgery
- •- Presence of pseudo-pancreatic cyst = 4 cm
- •- Continued excessive intake of alcohol or drug abuse
- •- Known allergy to pancreatin or inactive ingredients of Creon
- •- Suspected non-compliance or non-cooperation
- •- Intake of experimental drug within 4 weeks prior to study start
- •- Mental disability or any other lack of fitness, in the investigator's opinion, to preclude subject’s participation in or to complete the study.
- •- Known infection with HIV.
研究者
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