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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2006-004080-55-NL |
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Date of registration:
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19/01/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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26/04/2007 |
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Target sample size:
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-004080-55 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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The medical condition to be investigated is Cushing's disease which is caused by an ACTH producing pituitary adenoma
MedDRA version: 8.1
Level: LLT
Classification code 10011651
Term: Cushing's disease
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Intervention(s)
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Product Name: SOM230
Product Code: SOM230B
Pharmaceutical Form: Solution for injection
INN or Proposed INN: pasireotide
Concentration unit: µg microgram(s)
Concentration type: equal
Trade Name: Dostinex
Product Name: Dostinex
Pharmaceutical Form: Tablet
INN or Proposed INN: CABERGOLINE
CAS Number: 81409907
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Trade Name: Nizoral
Product Name: Ketoconazole
Pharmaceutical Form: Tablet
INN or Proposed INN: KETOCONAZOLE
CAS Number: 65277421
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
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Primary Outcome(s)
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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
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Primary end point(s): Normalization of cortisol production as measured by cortisol day profiles (in plasma and saliva) and urinary cortisol excretion
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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
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Secondary ID(s)
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N/A
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CSOM230B2402
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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