EUCTR2008-000061-37-IT进行中（未招募）不适用
A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of two doses of Zentase? (EUR-1008) in Chronic Pancreatitis (CP) patients with Exocrine Pancreatic Insufficiency (EPI) - PR-002
EURAND SPA0 个研究点目标入组 72 人开始时间: 2008年5月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
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.Male or female
- •2.Age over 18
- •3.Written, legally valid informed consent
- •4.Female patients must be using a medically acceptable form of birth control for the 30 days prior to the beginning of the study, have a negative pregnancy test prior to entering the study and agree to maintain adequate birth control measures during the whole duration of the study
- •5.Documented diagnosis of CP (ultrasound or X-Ray or CT scan or ERCP [Endoscopic Retrograde Cholangio-Pancreatograhy] or Endoscopic Ultrasound).
- •6.Documented EPI with FE ≤ 100 mcg/g of stool. If the FE test was performed in the six months preceding the date of the screening visit, the determination will not be repeated.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Subjects known to the Investigator to have a significant medical and/or mental disease that would compromise the patient?s welfare, pose and unacceptable risk to him/her or confound the study results
- •2.Participation in a clinical trial within 30 days prior to start of study
- •3.Cystic fibrosis
- •4.Continuing excessive alcohol assumption or drug abuse
- •5.Inability to cooperate adequately, according to the Investigator
- •6.Use and inability to discontinue non allowed concomitant medication, such as antacids (including PPIs and H2-blockers), laxatives, cholestyramines or cholestyramine-like substances
- •7.Uncontrolled diabetes mellitus
- •8.Allergy to pork protein
- •9.Drug hypersensitivity, allergic asthma, urticaria, or other relevant allergic diathesis
- •10.Pregnancy or lactation
- •11.Acute pancreatitis or acute exacerbation of chronic pancreatitis
- •12.Acute affection of the bile tract, e.g. acute exacerbation of biliary pancreatitis
- •13.Malassimilation syndrome caused by a metabolic disease or by surgery, not related to exocrine pancreatic insufficiency
- •14.Previous partial or complete extensive resection (i.e capable of affecting transit time and/or gastric emptying) of the stomach or the intestinal tract,
- •15.Evidence of gastric or duodenal ulcer
- •16.Chronic inflammatory bowel disease
- •17.Any history of pancreatic carcinoma and other non cutaneous malignancies (any history of)
- •18.Viral hepatitis with infectious virions in blood and/or body fluids (any etiology)
- •19.HIV infection
- •20.Hyperuricemia ( > 1.5 times Upper Normal Value for lab)
- •21.Hyperuricosuria (> 1.5 times Upper Normal Value for lab)
- •22.Any acute or chronic disease, which in the opinion of the investigator could influence study results or pose a risk to the patient?s safety.
研究者
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