NL-OMON30314
尚未招募
3 期
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 - Lanreotide for ileus based on peritonitis carcinomatosa
Ipsen Pharmaceuticals0 个研究点目标入组 6 人待定
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- intestinal obstruction
- 发起方
- Ipsen Pharmaceuticals
- 入组人数
- 6
- 状态
- 尚未招募
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •\- Patient having given written (personally signed and dated) 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 origin.
- •\- Patient having a peritoneal carcinomatosis confirmed by a CT Scan within the previous 3 months
- •\- Patient having an obstruction with at least two vomiting episodes per day or the presence of a nasogastric suction tube
- •\- Patient for whom surgery is inappropriate, either documented in the medical records or confirmed by a surgical advice within the previous 72 hours
- •\- Patients being treated by intra\-venous corticoids since at least 5 days and intravenous proton pump inhibitors
- •\- Patients having an estimated survival of more than one month
- •\- Patients accepting to comply fully with the protocol.
排除标准
- •\- Patient having an operable obstruction
- •\- Patient having a colic obstruction (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 blockers
- •\- Patient having a bowel obstruction which could be explained by a non malignant cause (e.g. 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 contraindication to intra\-muscular injections
- •\- Patient having a known hypersensitivity to any of the test materials or related compounds
- •\- Patient having previously entered this study
结局指标
主要结局
未指定
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