A trial with Metyrapone in Cushing's syndrome
- Conditions
- Cushing's syndromeTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2013-002063-26-IT
- Lead Sponsor
- S.C.D.U. MEDICINA INTERNA 1 Ospedale San Luigi Orbassano
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 15
Both sexes and age= 18 years
- Confirmed diagnosis of ACTH-independent Cushing’s syndrome validated by all the following criteria:
•two 24 h urinary collections for UFC at least 1.5 times the upper normal value, within 2 weeks prior to enrollment.
•levels of serum ACTH lower than the normal range
•CT-confirmed diagnosis of adrenal adenoma (size 2-4 cm, regular shape and margins, homogeneous density <10 HU). Unenhanced adrenal CT scan should be performed within 4 weeks prior to enrollment.
•Adrenalectomy planned.
- ECOG performance status = 2
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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
Patients who meet any of the following exclusion criteria are not eligible for enrollment.
- Prior metyrapone therapy
- Mitotane therapy within 6 months prior entering the study (mitotane levels should be undetectable prior to enrollment)
- Cushing’s syndrome with ACTH levels that are not clearly suppressed
- Hypercortisolism due to an adrenal tumor of uncertain dignity (suspicious for malignancy)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to assess the efficacy of METYRAPONE in attaining normalization of 24-h urinary free cortisol (UFC) excretion or a =50% decrease from baseline using the mean of 2 UFC measurements within 3 months of treatment. <br>;Secondary Objective: •time to response<br>•dose-response relationship <br>•effect of METYRAPONE on levels of serum cortisol, UFC, salivary cortisol, ACTH, 11-deoxicortisol, deoxycorticosterone, total testosterone, androstenedione, DHEA-S in terms of percent variation relative to baseline. <br>•improvement of the clinical signs associated to hypercortisolism (blood pressure, body mass index, waist)<br>;Primary end point(s): Primary<br>All patients will be included in the efficacy analysis. The primary efficacy variable is UFC. <br>;Timepoint(s) of evaluation of this end point: 3 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The secondary efficacy variables include other hormones (including serum and salivary cortisol levels), laboratory tests, and clinical signs and symptoms.;Timepoint(s) of evaluation of this end point: 3 months