NCT00747786已完成不适用
An Observational, Multicentre, Open Label, Non Interventional Programme to Assess the Long-Term Safety and Efficacy of Somatuline Autogel in the Treatment of Neuroendocrine Tumours When Administered by Patients or Their Partners ("Home Injection Group") or Administered by Healthcare Professionals
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- safety and local tolerability of Somatuline Autogel when administered by patients or their partners or from a healthcare professional
研究概览
简要总结
The purpose of this study, is to assess the safety and local tolerability of the long-term use of Somatuline Autogel when administered by patients or their partners ("Home Injection Group") and the safety and local tolerability in patients receiving their injection from a healthcare professional (HCP) ("Reference Group").
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •The patient must give written (personally signed and dated) informed consent for their data to be included in the database for this Post Marketing Surveillance programme and any subsequent analysis.
- •The patient must have been receiving treatment with Somatuline Autogel at a stable dose for at least 4 months.
- •The patient must have a diagnosis of neuroendocrine tumours
- •The patient must be at least 18 years of age
- •For patients receiving or intending to receive Somatuline Autogel by home injection:
- •The patient must be able to store Somatuline Autogel safely in a refrigerator in their own home and either collect it from their GP/Pharmacy on a monthly basis, or receive the medication by a home delivery service.
排除标准
- •The patient is pregnant or breast-feeding, unless continued treatment with Somatuline Autogel is clearly needed (as determined by the treating clinician).
结局指标
主要结局
safety and local tolerability of Somatuline Autogel when administered by patients or their partners or from a healthcare professional
时间窗: End of observational period
次要结局
- acceptability of home injections to patients, partners and healthcare professionals(End of observational period)
- efficacy of Somatuline Autogel(End of observational period)
- training requirements for patients / partners to perform home injection of Somatuline Autogel(End of observational period)
研究者
研究点 (5)
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