NCT00225979已完成3 期
Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Mean GH and IGF-I at baseline, week 12, 24 and 48
研究概览
简要总结
Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly. The objective of this study is to assess the safety and efficacy of long-acting repeatable formulation of octreotide and to compare it to the safety and efficacy of surgery in patients with acromegaly who have not had any previous treatment for acromegaly.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed or previously untreated acromegalic patients
- •Lack of suppression of GH nadir to <1.0 µg/L, after oral administration of 75 g of glucose (OGTT)
- •IGF-I levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender)
排除标准
- •Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass
- •No evidence of pituitary adenoma on Magnetic Resonance Imaging (MRI)
- •Symptomatic cholelithiasis
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
SMS995
Experimental
干预措施: Octreotide LAR (Drug)
结局指标
主要结局
Mean GH and IGF-I at baseline, week 12, 24 and 48
次要结局
- Tumor volume at baseline, week 24 and 48
- Signs and symptoms of acromegaly at baseline, week 12, 24 and 48
- Quality of life and sleep apnea at baseline, week 12, 24 and 48
- Safety and tolerability at any time on treatment
研究者
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