Prospektive, offene Studie zur Prüfung der Wirksamkeit der zusätzlichen Gabe des Somatostatinanalogon Octreotid (Sandostatin) bzw. des Dopaminagonisten Cabergolin (Dostinex) bei Patientin mit Akromegalie unter laufender Therapie mit Pegvisomant (Somavert);Prospective, open-label study to evaluate the efficacy of the combined treatment of somatostatin analogue octreotide (Sandostatin) or dopamine agonist cabergoline (Dostinex) in patients with acromegaly on stable therapy of pegvisomant (Somavert). - Efficacy of co-treatment in acromegaly

Department of Internal Medicine of the University of Munich0 个研究点开始时间: 2007年11月6日最近更新: 2013年5月20日

适应症

试验速览

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•1. Patients with acromegaly caused by pituitary adenoma currently on stable pegvisomant therapy
•2. Diabetic patients may be included. Glucose levels must be regularily (every 30 to 60 min) controlled throughout the whole study.
•3. Patients must not be co-treated with any other medication for acromegaly.
•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

•1. The patient has undergone radiotherapy within the last 2 years.
•2. The patient with any relevant acute disease.
•3. The patient has a history of hypersensitivity to octreotide (Sandostatin), octreotide LAR (Sandostatin LAR), cabergoline (Dostinex), pegvisomant (Somavert) or drugs with a similar chemical structure.
•4. Pregnancy or lactation.
•5. The patient has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject´s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.

发起方

Department of Internal Medicine of the University of Munich