EUCTR2005-003250-98-BE进行中（未招募）1 期
Sandostatine LAR in Dumping syndrome - Dumping Syndrome
Z LEUVE0 个研究点目标入组 0 人开始时间: 2005年10月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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. Patients with clinical suspect of a dumping syndrome with a total dumping score* (early and late symptoms) > 10, and a. a positive OGTT, in terms of a glycemia <60 mg/dl or Hematocrit increase > 3%, or an increase of pulse rate by 10 bpm Or b. documented spontaneous hypoglycemia (at least 1) 2. Age > 18 years 3. Diet of 6 meals a day with low concentration of mono- and disaccharides during 1 month before inclusion without sufficient improvement (= evaluation by physician and patient)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. Patients who haven’t been treated with Sandostatine during the last 6 months. 2. Cholecystolithiasis 3. Diabetes Mellitus 4. Coeliakie and Giardia 5. Severe oesophagitis 6. Gastric and duodenum ulcer 7. Patients who are: (a) pregnant, (b) breast feeding, (c) of childbearing potential without a negative pregnancy test prior to Study Day 1, and (d) female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial (postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential). 8. Hypersensitivity to octreotide or one of the compounds of the drug
研究者
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