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.
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