EUCTR2007-000375-42-SE进行中（未招募）不适用
A multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- •Inclusion Criteria at Visit 1
- •1. Signed informed consent.
- •2. Subject must be = 18 years and be of either sex.
- •3. Pancreatic exocrine insufficiency confirmed and documented in medical history by either a pathophysiological direct or indirect pancreatic function test
- •Clinical symptoms of steatorrhea stool fat that resolved or improved substantially upon administration of pancreatic enzyme supplementation.
- •4. Subjects are clinically stable on a stable daily dose of pancreatic enzyme supplementation for at least 3 months before the start of the study.
- •5. Subjects with CP with or without partial pancreatectomy due to underlying CP; CP
- •confirmed and documented in medical history by either computed tomography,
- •endoscope retrograde cholangiopancreaticography, plain film with pancreatic
- •calcifications, ultra-sonography (calcifications, duct dilatation), magnetic resonance
- •pancreatography, endoscope ultrasound, other radiological diagnosis captured by tools such as Cambridge classification3 and /or histology.
- •6. Females of non-childbearing potential (i.e., sterilized via hysterectomy or bilateral tubal ligation or at least 1 year postmenopausal) or if of childbearing potential must agree to practice effective barrier contraceptive methods, use an intrauterine device or use birth control pills or equivalent injectable contraceptive. The subject must have been practicing the selected method of birth control for at least 3 months prior to Visit 1.
- •Inclusion Criterion at Visit 3
- •1. Coefficient of fat absorption during the untreated part of the run-in period confirmed as < 80% at Visit 3.
- •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
- •Exclusion Criteria at Visit 1
- •1. Evidence of cardiovascular, gastrointestinal/ hepatic (except CP or pancreatectomy), renal, neurological/ psychiatric, respiratory, urogenital, hematological/ immunologic, head, ears, eyes, nose or throat, dermatologic/ connective tissue, musculoskeletal, metabolic/ nutritional, drug hypersensitivity, allergy, endocrine (except diabetes mellitus), major surgery (except gall bladder removal or appendectomy) or other relevant diseases as revealed by history, physical examination, and laboratory assessments which might limit participation or completion of the study.
- •2. Investigational drug intake within 90 days prior to the pre-assessment visit.
- •3. Gastrointestinal stricture, ileus or acute abdomen.
- •4. Any type of malignancy involving the GI tract in the last 5 years.
- •5. Current excessive intake of alcohol or drug abuse.
- •6. Allergic disease such as hypersensitivity pneumonitis, Aspergillus mediated asthma or allergic broncho-pulmonary aspergillosis.
- •7. Allergic reaction to Aspergillus fumigatus (FastCheckPOC®).4
- •8. Suspected non-compliance or non-cooperation.
- •9. Stenosis of the esophagus or stomach.
- •10. Mental disability or any lack of fitness that in the investigator’s opinion precludes the subject’s participation in the study.
- •11. Human immunodeficiency virus infection in medical history.
- •12. Subjects requiring treatment with non-permitted medication or exceeding the treatment limits of permitted medication.
- •13. Subjects in acute phase of pancreatitis.
- •14. Subjects with the following abnormalities of liver function tests at Visit 1 will be excluded: X3 elevation alanine transaminase (ALT) or aspartate transaminase (AST), X2 elevation of bilirubin or subjects with decompensated liver disease.
- •15. Subjects with impaired renal function: creatinine = 1.7 mg/dl.
- •16. Subjects with coeliac disease, total gastrectomy, Crohn’s disease and small bowel surgery.
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