SOMATULINE Autogel 90 mg IN DUMPING SYNDROME

Z Leuven0 个研究点目标入组 24 人开始时间: 2008年3月17日最近更新: 2022年3月28日

研究概览

暂无简介。

•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
•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
•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

•1.Patients who have been treated with Somatuline or Sandostatine LAR in the past
•2.Cholecystolithiasis
•3.Diabetes Mellitus
•4.Coeliakie and Giardia
•5.Untreated severe oesophagitis
•6.Untreated 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 lanreotide or one of the compounds of the drug.

发起方

Z Leuven