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

Active, not recruiting

• Conditions: The medical condition to be investigated is Cushing's disease which is caused by an ACTH producing pituitary adenoma; MedDRA version: 8.1Level: LLTClassification code 10011651Term: Cushing's disease

• Registration Number: EUCTR2006-004080-55-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the trial is to maximize the number of patients with Cushing's disease in whom normalization of cortisol production can be achieved by medical therapy with SOM230 monotherapy or SOM230 combination therapy with dopamine agonists and ketoconazole;Secondary Objective: To examine whether this cortisol lowering therapy has benificial effects on quality of life, blood pressure, glucose tolerance and clotting system in patients with Cushing's disease;Primary end point(s): Normalization of cortisol production as measured by cortisol day profiles (in plasma and saliva) and urinary cortisol excretion