Stepwise Medical Treatment of Cushing’s Disease: a prospective open label multi-center trial with SOM230 mono- and combination therapy with dopamine agonists and ketoconazole - Stepwise Medical Treatment of Cushing's Disease

Erasmus MC0 个研究点开始时间: 2007年1月19日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Sixteen patients will be included with newly diagnosed Cushing’s disease or with residual hypercortisolism after recent transsphenoidal adenomectomy. Patients with recurrent Cushing’s disease can also be included.
•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

•- Patients with poorly controlled diabetes mellitus indicated by a HbA1c % > 8.5 %.
•- Patients with a disturbed liver function indicated by serum bilirubin, ALAT, ASAT or alkaline phosphatase levels > 2.5 x ULN.
•- Patients with renal insufficiency indicated by serum creatinine levels > 2.0 x ULN
•- Patients who are already treated with cortisol lowering therapy can only be included after a wash-out period of 4 weeks followed by re-assessment for hypercortisolism.
•- Patients with a history of pituitary irradiation
•- Pregnant patients or patients who desire to become pregnant during the study period.

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