NCT00088582已完成2 期
A Multicenter, Randomized, Crossover, Open Label Dose Finding Study to Compare the Safety, Efficacy and PK/PD Relationship of Multiple Doses of SOM230 and Sandostatin in Acromegalic Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 5
- 主要终点
- Circulating GH- and IGF-1 concentrations measured every 2 weeks
研究概览
简要总结
5 month study comparing SOM230 s.c. and Sandostatin s.c. in acromegalic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Patients with active acromegaly due to a pituitary adenoma
- •Patients who have been previously treated for acromegaly with certain medications may be required to be without certain medications prior to entering the study
排除标准
- •Patients with compression of the optic chiasm causing any visual field defect
- •Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression
- •Patients who have received radiotherapy in the 2 years prior to the start of the trial
- •Patients who have congestive heart failure, unstable angina, cardia arrhythmia, or a history of acute myocardial infarction within the three months preceding enrollment
- •Patients with gallstone disease
- •Patients with chronic liver disease
- •Known hypersensitivity to Sandostatin or Sandostatin LAR
- •Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control and highly effective method for birth control
- •History of immunocompromise, including a positive HIV test result
- •Patients who have a history of alcohol or drug abuse in the six-month period prior to the enrollment visit
- •Patients who have participated in any clinical investigation with an investigational drug within 4 weeks prior to dosing
研究组 & 干预措施
Sandostatin s.c. (Octreotide)
Experimental
干预措施: Pasireotide (SOM230), Octreotide (Sandostatin) (Drug)
Pasireotide (SOM230)
Experimental
干预措施: Pasireotide (SOM230), Octreotide (Sandostatin) (Drug)
结局指标
主要结局
Circulating GH- and IGF-1 concentrations measured every 2 weeks
时间窗: 6 months
次要结局
- Safety and efficacy of multiple doses of Pasireotide s.c. and Sandostatin s.c.(Every 3 months)
研究者
研究点 (5)
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