se of somatostatin analogue therapy as primary medical treatment of acromegaly - medical treatment of acromegaly

Plymouth Hospital NHS Trust, R&D dept0 个研究点目标入组 10 人开始时间: 2005年9月14日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•The patient must give written (personally signed and dated) informed consent
•The patient is over 18 years of age inclusive.
•The patient has active acromegaly as diagnosed by oral glucose tolerance test and IGF-1 measurement. Acromegaly must be confirmed prior to study entry based on failure to suppress GH during an oral glucose tolerance test and IGF-1 above the normal range.
•The patient has a pituitary adenoma tumour size greater than 5 mm along the longest axis on MRI.
•The patient has a life expectancy of at least 2 years.
•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

•The patient is considered unfit for surgery.
•The patient has a significant visual field defect thought to be due to optic chiasm compression at the time of presentation where the risk of visual loss is considered too great to delay surgery.
•The patient has a pituitary adenoma tumour of 5 mm or less along the longest axis, with margins clearly defined within pituitary fossa.
•The patient has had any prior pituitary surgery (adenectomy).
•The patient has received pituitary radiotherapy within one year prior to screening.
•The patient has been previously treated with a GH antagonist or a somatostatin analogue.
•The patient has clinically significant renal or hepatic abnormalities.
•The patient is pregnant or lactating.

发起方

Plymouth Hospital NHS Trust, R&D dept