NCT00216398已完成4 期
A Phase IV, Open-label, Single Group Study to Evaluate the Dosing, Efficacy and Safety of Lanreotide Autogel® in Patients With Acromegaly Previously Treated With Octreotide LAR
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
- 8
- 试验地点
- 2
- 主要终点
- The percentage of patients with GH control (<5.0 mU.L) and normalised IGF-1 at week 44 compared to the baseline (Week 0) visit.
研究概览
简要总结
The purpose of this study is to assess the efficacy, safety and patient acceptability of Somatuline Autogel in patients with acromegaly previously treated with octreotide LAR.
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
- •Clinical diagnosis of acromegaly
- •The patient must have been tested at Week -4 (4 weeks prior to the Baseline visit) and shown to have a GH level <10 mU/L.
- •The patient must have been treated with a stable dose of octreotide LAR for at least four months prior to study entry
- •Life expectancy of at least 2 years
排除标准
- •Adenectomy within past 6 months, or likely during study period
- •Radiotherapy for acromegalic disease within 1 year, or likely during study period
- •Unstable concomitant dopamine agonist therapy
结局指标
主要结局
The percentage of patients with GH control (<5.0 mU.L) and normalised IGF-1 at week 44 compared to the baseline (Week 0) visit.
次要结局
- The percentage of patients with GH control (< 5.0 mU/L) at each visit to week 44 compared to the baseline (Week 0) visit.
- Change in the IGF-1 values compared to the baseline (Week 0) visit.
- Change in serum lanreotide levels compared to the baseline (Week 0) visit.
- Investigator evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.
- Change in the serum octreotide levels compared to the baseline visit.
- Patient evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.
- The percentage of patients with normalised IGF-1 compared to the baseline visit.
- Change in the GH values compared to the baseline (Week 0) visit.
研究者
研究点 (2)
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