EFFECTIVENESS AND TOLERABILITY OF TREATMENT WITH CABERGOLINE IN PATIENTS WITH CUSHING S SYNDROME - CABERGOLINE IN CUSHING S SYNDROME

• Register: EUCTR
• Last refreshed on: 26 June 2012
• Main ID: EUCTR2006-005218-11-IT
• Date of registration: 03/04/2007
• Prospective Registration: No
• Primary sponsor: ASSOCIAZIONE ITALIANA ENDOCRINOLOGIA-METABOLISMO-IPOFISI
• Public title: EFFECTIVENESS AND TOLERABILITY OF TREATMENT WITH CABERGOLINE IN PATIENTS WITH CUSHING S SYNDROME - CABERGOLINE IN CUSHING S SYNDROME
• Scientific title: EFFECTIVENESS AND TOLERABILITY OF TREATMENT WITH CABERGOLINE IN PATIENTS WITH CUSHING S SYNDROME - CABERGOLINE IN CUSHING S SYNDROME
• Date of first enrolment: 15/09/2006
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-005218-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: I gruppi di controllo sono in parte paralleli ed in parte retrospettivi rispetto al gruppo di studio If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Altro farmaco e Altro trattamento

Countries of recruitment

Italy

Key inclusion & exclusion criteria

Inclusion criteria:
1 Age above 18 and below 65 years 2 Diagnosis of Cushing s syndrome due to pituitary or adrenal tumor or ectopic ACTH secretion, performed by the standard diagnostic procedures evaluation of urinary cortisol secretion, cortisol circadian rhythm,low-dose and high-dose dexamethasone test, CRH and/or DDAVP test 3 Documentation of baseline cortisol urinary levels at least two times higher and less than four times lower than the upper limit of normal range 4 Informed consent
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) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1 Pregnancy or Lactation; 2 Documented intolerance to cabergoline; 3 Liver, renal or cardiovascular insufficiency; 4 Specific conditions and/or tumor characteristics which require an immediate alternmative treatment aggressivity of the neoplasm or sever organ compromission


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Cushing syndrome
MedDRA version: 9.1 Level: LLT Classification code 10011652 Term: Cushing's syndrome

Intervention(s)

Trade Name: DOSTINEX
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: .5-

Trade Name: NIZORAL
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Primary Outcome(s)

Secondary Objective: Evaluation of the effectiveness of cabergoline in inducing tumor shrinkage and the improvement of the systemic complications of hypercortisolism, inlcuding metabolic systemic arterial hypertension, diabetes mellitus or impairment of glucose tolerance, dyslipidemia , cardiovascular thichening of intima-media of the main vessels, presence of atherosclerotic plaques, cardiac hypertrophy and dysfuncion osteoarticular osteoporosis, osteoarthrosis , reproductive-sexual gonadal dysfunction, sexual dysfunction complications, and on the quality of life

Primary end point(s): Percentage of normalization of cortisol secretion

Main Objective: Evaluation of the effectiveness of cabergoline in inducing ACTH and cortisol secretion inhibition in patients with Cushing syndrome

Secondary ID(s)

FARM58SK29