NCT00088608已完成2 期
A Multicenter, Open Label Study to Assess the Safety and Efficacy of 600 µg SOM230, Administered Subcutaneously, b.i.d. in Patients With Cushing's Disease
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 10
- 主要终点
- Urinary Free Cortisol after 15 days of treatment
研究概览
简要总结
The study treatment period is 15 days in length and includes patients with pituitary Cushing's disease who are candidates for surgical intervention as well as and patients who have recurrent Cushing's post operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pituitary Cushing's disease within the two months prior to study entry
- •Patients for whom written informed consent to participate in the study has been obtained
- •Female patients of child bearing potential who have not undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation must agree to use barrier contraception throughout the course of the study, and for one month after the study has ended
排除标准
- •Female patients who are pregnant or lactating
- •Patients who have been previously treated with certain medications may be required to be without certain medications prior to entering the study
- •Poorly controlled diabetes mellitus as indicated by the presence of ketoacidosis or HgbA1C > 10
- •Patients who have congestive heart failure, unstable angina, cardiac arrhythmia or history of acute MI less than one year prior to the study entry or clinically significant impairment in cardiovascular function (e.g. blood pressure of 190/100mmHg or greater)
- •Patients with chronic liver disease
- •Patients with clotting disorders or abnormal blood counts
- •History of immuno-compromise, including a positive HIV test result
- •Patients with active gall bladder disease
- •Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
- •Patients with active malignant disease (with the exception of basal cell carcinoma or carcinoma in situ of the cervix)
结局指标
主要结局
Urinary Free Cortisol after 15 days of treatment
次要结局
- ACTH
- Serum cortisol
- Clinical manifestations
- Pharmacokinetics
- Safety
- Tolerability
- Development of biomarkers
研究者
研究点 (10)
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