EUCTR2004-001091-40-FI进行中（未招募）不适用
A Phase III, Prospective, Multicentre, Randomised, Open, Parallel Group Comparison of Lanreotide Autogel (90 and 120mg) Administered by Deep Subcutaneous Injection Every Four Weeks, with Sandostatin LAR Depot (20 and 30mg) Administered by Intramuscular Injection, Every Four Weeks for Six Months, in the Treatment of Clinical Symptoms Associated with Carcinoid Syndrome.
Beaufour Ipsen Pharma0 个研究点目标入组 196 人开始时间: 2004年8月6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
- 196
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
- •At the screening visit patients MUST satisfy all of the following criteria before they
- •will be allowed to participate in the study:
- •a) Male or female of 18 years of age or older.
- •b) Histologically confirmed diagnosis of a neuroendocrine tumour of the carcinoid
- •c) Documented evidence of carcinoid syndrome (flushing and/or diarrhoea)
- •attributable to a primary tumour of the lung, stomach or mid-gut
- •d) Previous positive Octreoscan.
- •e) World Health Organisation (WHO) performance score lower than 2 (Appendix 2 of protocol).
- •f) Written informed consent given.
- •At the baseline visit patients MUST satisfy the following criteria before they are randomised to receive study treatment:
- •g) Stool and/or flushing frequency of =3 episodes/day (average over a minimum
- •five consecutive days).
- •h) Patients who have previously been treated with somatostatin analogues must
- •have discontinued treatment for a sufficient period of time (a washout period of
- •at least 7 days for immediate release formulations and up to 2 months for
- •prolonged release formulations is usually required). Compared with their
- •controlled state on treatment, these patients must show a clinically significant
- •deterioration (at least two episodes) of either symptom. For example, a patient
- •considered to be controlled on their previous treatment with an estimated stool
- •frequency of two episodes per day, must achieve a stool frequency of at least
- •four episodes per day (average over a minimum five consecutive days).
- •i) WHO performance score lower than 2 (Appendix 2 of protocol).
- •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
- •If any of the following criteria apply the patient must not enter/continue in the study:
- •a) VIPoma or other non-carcinoid tumour.
- •b) Treatment with interferon, chemotherapy or radiotherapy given within 30 days
- •prior to inclusion, or planned during the study.
- •c) Radionuclide treatment within three months prior to inclusion, or planned during
- •d) Presence of other active malignant pathology (except basal cellular carcinoma of
- •the skin and/or in situ carcinoma of the cervix/uterus).
- •e) Surgical procedure or embolisation procedure (with or without cytotoxic agents)
- •of the tumour within three months prior to inclusion, or planned during the
- •f) Patient is pregnant, lactating, or not taking adequate precautions against
- •pregnancy. (NB Patients of childbearing potential must demonstrate a negative
- •serum pregnancy test, and be using appropriate double methods of contraception, such as approved hormonal contraceptives or a condom used with a spermicide).
- •g) Life expectancy of less than 6 months.
- •h) Known hypersensitivity to any of the test materials or related compounds.
- •i) Any investigational drug given within 30 days prior to inclusion or expected to be given during the study.
- •j) Previous participation in this study.
- •k) No access to a telephone for completion of the daily telephone diary.
- •l) In the opinion of the investigator the patient is unable and/or unwilling to
- •comply fully with the protocol and the study instructions.
研究者
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