NCT00149188已完成4 期
A Phase IV, Multicentre, Open Label, Controlled Study to Assess the Ability of Patients With Acromegaly, or Their Partners, to Administer Somatuline Autogel.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 30
- 试验地点
- 20
- 主要终点
- To assess the ability of patients or their partners to perform unsupervised Somatuline Autogel injections.
研究概览
简要总结
The purpose of this study is to allow patients with acromegaly, or their partners, to learn how to successfully inject Somatuline Autogel at home. Ability to perform unsupervised injections whilst maintaining adequate disease control will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 have a clinical diagnosis of acromegaly
- •The patient must have been tested and shown to have a GH level less than or equal to 10 micrograms/L within 28 days prior to the baseline visit
- •The patient must be currently treated with Somatuline Autogel and have been stable on their current dose for at least 6 months immediately prior to screening
- •The patient must be able to store study medication in a refrigerator in their own home
排除标准
- •The patient has had pituitary surgery (adenomectomy) within 6 months prior to screening
- •The patient has received pituitary radiotherapy within one year prior to screening
- •The patient is likely to require pituitary surgery (adenomectomy) or to receive radiotherapy during the study period
- •The patient is currently receiving a GH antagonist or a somatostatin analogue other than Somatuline Autogel
结局指标
主要结局
To assess the ability of patients or their partners to perform unsupervised Somatuline Autogel injections.
次要结局
- To assess whether administration of unsupervised injections of Somatuline Autogel has any effect on GH and IGF-1 control or serum lanreotide levels.
- To assess patient/partner and healthcare professional experience with unsupervised injections.
- To assess the safety of patients or their partners performance of unsupervised Somatuline Autogel injections.
研究者
研究点 (20)
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