EUCTR2007-006514-42-DK进行中（未招募）不适用
A PHASE IV, OPEN-LABEL, RANDOMISED, CROSS-OVER STUDY TO ASSESS PATIENT PREFERENCE AND HEALTH ECONOMY IN PATIENTS WITH NEUROENDOCRINE TUMOURS, TREATED WITH LANREOTIDE AUTOGEL GIVEN AS SELF ADMINISTRATIO
Institut Produits Synthèse (IPSEN) AB0 个研究点目标入组 26 人开始时间: 2008年1月28日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 26
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
- •(1)Provision of written informed consent. Provision of written informed consent by the patient’s partner if he/she will be administering the Somatuline Autogel injections during the self administration block.,
- •(2)Male or female aged 18 years of age or older,
- •(3)Treated with Somatuline Autogel 90 mg or120mg every 28th day for carcinoid symptoms on a stable dose for at least 3 months prior to inclusion. The patient is presumed to be clinically stable during the coming months,
- •(4)Neuroendocrine tumour confirmed by biopsy and visible on radiology,
- •(5)Ability to store the study medication in a refrigerator at home.
- •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
- •The presence of any of the following will exclude a patient from inclusion in the study:
- •(1)Has a history of hypersensitivity to lanreotide or drugs with a similar chemical structure,
- •(2)Has been treated with any other investigational medicinal product (IMP) within the last 3 months before study entry,
- •(3)Has a risk of pregnancy or performing lactation, or is likely to father a child during the study. Females of childbearing potential must provide a negative pregnancy test at start of study and must be using oral, double barrier or injectable contraception. (Non childbearing potential is defined as post-menopause for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study),
- •(4)Has a history of, or known current, problems with substance or alcohol abuse,
- •(5)Has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude,
- •(6)Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the patient’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study,
- •(7)Has a life expectancy less than a year, as judged by the Investigator,
- •(8)The patient or their partner is not considered competent in injection technique, as judged by the Investigator,
- •(9)The patient has previously entered this study.
研究者
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