NCT00216372已完成3 期
Phase III, Multicentre, Randomised, Double-blind, Comparative Study to Assess the Efficacy and Safety of Lanreotide 30 mg Versus Placebo as a Palliative Treatment of Clinical Symptoms Associated With Intestinal Obstruction Due to Peritoneal Carcinomatosis in Inoperable Patients.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 80
- 试验地点
- 52
- 主要终点
- Percentage of responder patients (patient with 1 or less vomiting episode per day during at least 3 consecutive days or in whom nasogastric tube (NGT) has been removed during at least three consecutive days without vomiting recurrence)
研究概览
简要总结
The purpose of this study is to determine whether lanreotide 30mg microparticles are effective in the relief of clinical symptoms due to small bowel obstruction in inoperable patients with peritoneal carcinomatosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •digestive obstruction located in the upper part of the gastro-intestinal tract
- •digestive obstruction of malignant origin
- •peritoneal carcinomatosis confirmed by a CT Scan
- •at least two vomiting episodes per day or a presence of a nasogastric suction tube
- •inoperable patients
排除标准
- •specific anticancer therapy within the previous 15 days
- •signs of bowel perforation
- •somatostatin or any analogue as treatment of the bowel obstruction
研究组 & 干预措施
1
Experimental
干预措施: Lanreotide (microparticle formulation) (Drug)
2
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Percentage of responder patients (patient with 1 or less vomiting episode per day during at least 3 consecutive days or in whom nasogastric tube (NGT) has been removed during at least three consecutive days without vomiting recurrence)
时间窗: On day 7 (plus 1 day at the latest) after the first injection
次要结局
- Intensity of abdominal pain(Daily for the duration of the study)
- Number of daily vomiting episodes or measurement of the daily drainage by NGT(Daily for the duration of the study)
- Number of daily nausea episodes(Daily for the duration of the study)
- Number of days with no vomiting episodes(For the duration of the study)
- Symptom relief duration(Between the first day of clinical response and the end of follow-up)
- Well-being(Daily for the duration of the study)
研究者
研究点 (52)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Lanreotide Versus Placebo for Treatment of Patients With Digestive FistulaeDigestive FistulaeNCT00729313Ipsen111
已完成
2 期
Efficacy and Safety of Lanreotide 120 Milligram (mg) as a Palliative Treatment of Clinical Symptoms Associated With Malignant Intestinal Obstruction in Inoperable PatientsMalignant Intestinal ObstructionNCT01076803University Hospital, Ghent40
已完成
3 期
Efficacy and Tolerability of Lanreotide (Autogel 120 mg) in Patients With AcromegalyAcromegalyNCT00499993Ipsen63
已完成
3 期
Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg Prolonged Release (PR) in AcromegalyAcromegalyNCT02493517Ipsen128
已完成
2 期
Phase 2 study of ITM-014 in patients with neuroendocrine tumoureuroendocrine tumourJPRN-jRCT2080222325TEIJIN PHARMA LIMITED32