NCT00499993已完成3 期
Phase III, Multicentre, Open Clinical Study on the Efficacy and Tolerability of a New Slow-release Formulation of Lanreotide (Autogel 120 mg) in Patients With Active Acromegaly
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 63
- 试验地点
- 48
- 主要终点
- Growth hormone assessment
研究概览
简要总结
The purpose of the protocol, is to evaluate if lanreotide Autogel 120 mg is effective in the control of Growth Hormone (GH) secretion in patients with active acromegaly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Documented diagnosis of active acromegaly, defined by serum GH levels above 5 µg/L, absence of reduction of serum GH levels below 1µg/L after oral glucose tolerance test (OGTT) and abnormal IGF-1 values
排除标准
- •Patients who have undergone pituitary surgery less than 3 months before selection
- •Patients previously treated with radiotherapy
- •Patients previously treated with somatostatin analogue except for a pre-surgical treatment not longer than 3 months
结局指标
主要结局
Growth hormone assessment
时间窗: At every visit
次要结局
- Safety assessment evaluated by clinical data(At every visit)
- Insulin-like Growth Factor 1 (IGF-1) and Acid-Labile Subunit (ALS) assessments(At every visit (with the exception of ALS at study inclusion))
- Prolactin (PRL) assessment(At study inclusion, visit 1 and at the final visit of the study)
- Quality of life(At visit 1 and at the final visit of the study)
- Lanreotide assessment(At every visit)
- Clinical symptoms(At every visit)
- Tumour size(At inclusion and at the final visit of the study)
- Safety assessment evaluated by laboratory data(At inclusion visit and at the final visit of the study)
- Evaluation of carotid vessels (on an optional basis)(At inclusion and at the final visit of the study)
研究者
研究点 (48)
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