NCT00796783终止不适用
A Study to Confirm the Presence of Recurrent or Persistent Cushing's Syndrome in Patients With Clinical Signs or Symptoms of Hypercortisolemia Who Have Been Treated for Cushing's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 3
- 主要终点
- To confirm the presence of recurrent or persistent endogenous Cushing's syndrome in patients who have had primary surgical and/or radiation therapy for Cushing's disease and continue to manifest symptoms and signs of hypercortisolemia.
研究概览
简要总结
This is an observational study to confirm the presence of recurrent or persistent endogenous Cushing's syndrome in patients who have had primary surgical and/or radiation therapy for Cushing's disease and continue to manifest symptoms and signs of hypercortisolemia.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Are at least 18 years of age.
- •Have a presumptive diagnosis of Cushing's disease (Cushing's syndrome due to an ACTH secreting pituitary tumor).
- •Have previously had pituitary surgery and/or pituitary radiation with the intent of curing or treating Cushing's disease.
- •Have clinical symptoms and signs of hypercortisolism.
- •Are able to provide written informed consent.
- •Are expected to complete the study.
排除标准
- •Are surgical candidates for pituitary surgery or have had pituitary surgery within 8 weeks before screening.
- •Have taken any medication that may interfere with protocol testing procedures within 30 days of initial screening (phenobarbital, phenytoin, carbamazepine, oxcarabazepine, primidone, rifampin, rifapentine, rifabutin, ethosuximide, pioglitazone, efavirenz, neviparine, modafinil, St. Johns wort, glucorticoids, estrogen containing oral contraceptives).
- •Have received investigational treatment (drug, biologic agent or device) within 30 days of screening.
- •Have a non-endogenous source of hypercortisolemia such as factitious hypercortisolemia (exogenous source of glucocorticoid, iatrogenic Cushing's syndrome), factitious or therapeutic use of ACTH.
- •Have Pseudo-Cushing's syndrome. Subjects with suspected Pseudo-Cushing's syndrome such as those with severe obesity, major depression or a history of alcoholism.
- •Uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
- •Have renal failure as defined by a serum creatinine of 202 mg/dL.
- •Elevated total bilirubin (>1.5x ULN), elevated ALT(>3x ULN) or AST (>3x ULN).
研究组 & 干预措施
1
Patients with presumed Cushing's disease who have failed pituitary surgery and/or radiation and require medical treatment for recurrent or persistent Cushing's syndrome.
干预措施: Cushing's syndrome confirmation (Drug)
结局指标
主要结局
To confirm the presence of recurrent or persistent endogenous Cushing's syndrome in patients who have had primary surgical and/or radiation therapy for Cushing's disease and continue to manifest symptoms and signs of hypercortisolemia.
时间窗: up to 16 weeks
次要结局
未报告次要终点
研究者
研究点 (3)
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