EUCTR2006-004679-36-FR进行中（未招募）不适用
Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. - HRA052015 in EAS
aboratoire HRA Pharma0 个研究点目标入组 22 人开始时间: 2006年9月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects will be included if they have ALL of the three following criteria:
- •1. Hypercortisolism from Cushing’s syndrome caused by ectopic ACTH secretion confirmed by:
- •- Inferior petrosal sinus sampling (IPSS) with a central to peripheral ACTH ratio of less than 2.0 before CRH administration and less than 3.0 after CRH administration.
- •- or biopsy with ACTH immunoreactivity.
- •- or presence of a tumor evidenced by imaging combined with both a negative CRH test and a negative 8 mg dexamethasone suppression test.
- •No major change in tumor status/anti-tumor therapy should be expected during the study
- •2. Glucose intolerance AND/OR hypertension that is considered to be caused or worsened by the hypercortisolism:
- •oDiabetes defined by
- •?fasting plasma glucose level = 7.0 mmol/l (126 mg/dl)
- •? or 2-hour glucose plasma level after 75 g OGTT = 11.1 mmol/l (200 mg/dl)
- •?or treated diabetes
- •or glucose intolerance defined by:
- •?fasting plasma glucose values between 5.5 mmol/l (100 mg/dl) and 7.0 mmol/l (126 mg/dl) or 2-hour glucose plasma level after 75 g OGTT = 7.8 mmol/l (140 mg/dl) ) and < 11.1 mmol/l (200 mg/dl)
- •?Prior to study entry, fasting blood sugar must be less than 11.1 mmol/l (200 mg/dl) for at least two weeks
- •oHypertension defined by
- •?systolic BP = 140 mm Hg and/or diastolic BP = 90 mm Hg
- •?Prior to study entry, BP must be less than 180/110 mmHg for at least two weeks
- •?or treated hypertension
- •3. At least one of the following symptoms attributable to the Cushing’s syndrome:
- •oBody weight increase or truncal obesity
- •oDepression or treated depression or psychiatric disorder
- •oProximal muscle weakness
- •o Hirsutism
- •o Hypokalemia
- •o Violaceous striae
- •o In men, gynecomastia or libido decrease
- •o Impaired cognition or memory
- •oHyperpigmentation
- •oAmenorrhea
- •oOsteopenia or osteoporosis
- •In addition, the following criteria should be met:
- •-Written informed consent to participate in the study
- •-Female subjects should be sterilized, post-menopausal, sexually inactive or willing to use barrier methods of contraception throughout the study.
- •-Subject willing to return to investigational site during the full course of the study
- •-Age in the range of 18 to 75 years inclusive
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Evidence for Cushing’s disease as judged by positive inferior petrosal sinus sampling or a lesion on pituitary MRI with positive CRH test
- •- Suspected or known adrenocortical cancer or adenomas, as judged by ACTH values < 10 pg/ml and adrenal mass
- •- Subjects with cyclic Cushing’s syndrome defined by at least 3 measurements of Urinary Free Cortisol over the previous two months without normal values.
- •- Children (age less than 18) and subject of more than 75 years of age
- •- Pregnant or lactating women. A urinary pregnancy test will be performed in women of childbearing potential unless they have a history of menopause prior to Cushing’s syndrome or hysterectomy
- •- Life expectancy less than three months
- •- Severe uncontrolled diabetes
- •- Grade III or IV hypertension
- •- Recent (less than two weeks prior to inclusion) initiation of corrective treatments for diabetes, hypertension or depression
- •- Clinically significantly impaired cardiovascular function (e.g. stage IV cardiac failure)
- •- Severe liver disease (liver enzymes = 3 x the institutional upper limit of normal range)
- •- Severe renal impairment (serum creatinine = 2.2 mg/dl or creatinine clearance < 30 ml/min)
- •- Uncontrolled severe active infection
- •- In women, known endometrial cancer, history of endometrial hyperplasia or vaginal bleeding of unknown cause
- •- Recent (less than two weeks prior to inclusion) initiation of or significant change in dose of anti-tumor therapy
- •- Treatment with approved or experimental steroidogenesis inhibitors, adrenolytic agents or somatostatin analogues within four weeks of admission
- •- Plasma mitotane concentration > 5 µg/ml
- •- Impaired mental capacity or markedly abnormal psychiatric evaluation that precludes informed consent
- •- Body weight over 136 kg, which is the limit for the tables used in the scanning areas
研究者
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