跳至主要内容
临床试验/EUCTR2009-012981-30-BE
EUCTR2009-012981-30-BE进行中(未招募)1 期

Prospective study to assess the efficacy and safety of lanreotide 120 mg as treatment of clinical symptoms associated with inoperable intestinal obstruction

niversity Hospital Ghent0 个研究点目标入组 40 人开始时间: 2009年7月1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
入组人数
40

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

  • Patient MUST satisfy ALL of the following inclusion criteria before he/she will be allowed to participate in the study:
  • Patient have to give written (personally signed and dated) informed consent before completing any study-related procedure.
  • Demographic criteria
  • =18 years of age.
  • Criteria related to the disease
  • diagnosis of a digestive obstruction of malignant origin, confirmed by a CT scan within the previous 3 months,
  • inoperability as decided after surgical consultation
  • 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

  • If any of the following applies, the patient MAY NOT enter in the study:
  • Criteria related to the disease:
  • operable obstruction,
  • bowel obstruction that can be explained by a non malignant cause (e.g. hypokaliaemia, drug side-effects, renal insufficiency),
  • signs of bowel perforation,
  • Criteria related to the studied treatment:
  • prior treatment with somatostatin or any analogue as treatment of the bowel obstruction in the last 60 days,
  • a known hypersensitivity to any of the test materials or related compounds.
  • Other criteria
  • previously enrolment in this study.
  • female patients who are lactating or child bearing potential without adequate contraceptive measures.

研究者

发起方
niversity Hospital Ghent

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