EUCTR2005-002349-38-NL
进行中（未招募）
不适用
Phase III multicentre, Randomised, Double Blind, Comparative study to assess the efficacy and safety of lanreotide 30mg versus placebo as a palliative treatment of clinical symptoms associated with intestinal obstruction due to peritoneal carcinomatosis in inoperable patients
Beaufour Ipsen Pharma-Ipsen Biotech Department0 个研究点目标入组 80 人2006年12月22日
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Patient having a high digestive obstruction of malignant origin i.e. located on the upper part of the gastro-intestinal tract (stomach, duodenum, small bowel) for whom surgery is inappropriate.
- 发起方
- Beaufour Ipsen Pharma-Ipsen Biotech Department
- 入组人数
- 80
- 状态
- 进行中（未招募）
- 最后更新
- 14年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Patient having given a written informed consent before completing any study\-related procedure,
- •Patient being over 18 years of age,
- •Patient having a high digestive obstruction i.e. located on the upper part of the gastro\-intestinal tract (stomach, duodenum, small bowel) ,
- •Patient having a digestive obstruction of malignant origin1,
- •Patient having peritoneal carcinomatosis confirmed by a CT Scan within the previous 3 months1,
- •Patient having an obstruction with at least two vomiting episodes per day or the presence of a nasogastric suction tube1,
- •Patient for whom surgery is inappropriate, either documented in the medical records or confirmed by a surgical advice within the previous 72 hours1,
- •Patient being treated by intra\-venous corticoids since at least 5 days and intra\-venous proton pump inhibitors,
- •Patient having an estimated survival of more than one month,
- •Patient accepting to comply fully with the protocol.
排除标准
- •Patient having an operable obstruction1,
- •Patient having a colic obstruction1 (must be documented by an abdominal X\-Ray within the previous 3 days),
- •Patient having received any specific anticancer therapy within the previous 15 days,
- •Patient receiving any antiH2 receptor blockers1,
- •Patient having a bowel obstruction which could be explained by a non malignant cause (hypokaliaemia, drug side\-effects, renal insufficiency,..),
- •Patient having signs of bowel perforation,
- •Patient having received somatostatin or any analogue as treatment of the bowel obstruction,
- •Patient having a contra\-indication to intra\-muscular injections,
结局指标
主要结局
未指定
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