EUCTR2016-001790-33-BE进行中（未招募）1 期
A PHASE II, SINGLE-CENTRE, PROSPECTIVE EXPLORATORY TRIAL TO ASSESS THE EFFICACY OF LANREOTIDE AUTOGEL 120 MG IN THE SYMPTOMATIC TREATMENT OF ACUTE RADIATION INDUCED DIARRHEA
niversity Hospital Ghent0 个研究点目标入组 40 人开始时间: 2016年5月12日最近更新:
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
- •Male or female patient with radiation induced diarrhoea requiring daily loperamide intake (=16mg) for at least 3 consecutive days.
- •Administration of lanreotide 120mg at least 7 days before ending radiotherapy.
- •= 3 stools per 24 hours before radiotherapy
- •> 3 stools per 24 hours in the screening period.
- •Subject having provided written informed consent prior to any study related procedures
- •Subject of 18 years and older
- •Subject mentally fit for completing a diary
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Has already received a treatment with somatostatin analogues for the treatment of refractory diarrhea,
- •Has received a treatment with somatostatin analogues for any other indication within the last 6 months before study entry,
- •Has received a treatment with laxatives within the last week before study entry,
- •Suffers from IBS with alternating bowel habits and predominant constipation,
- •Suffers from infectious and/or inflammatory gastro-enteritis (colitis ulcerosa, crohn´s disease and macroscopic colitis),
- •Has a known intolerance to lanreotide or other somatostatin analogues,
- •Has abnormal baseline findings or any other medical condition(s) that, in the opinion of the Investigator, might jeopardise the subject’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
研究者
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