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- Conditions
- de novo or persistent/recurrent Cushing diseaseTherapeutic area: Diseases [C] - Hormonal diseases [C19]MedDRA version: 14.1Level: PTClassification code 10011652Term: Cushing's syndromeSystem Organ Class: 10014698 - Endocrine disorders
- Registration Number
- EUCTR2006-004111-22-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
`Male or female patients aged 18 years or greater `Patients with confirmed diagnosis of ACTH-dependent Cushing`s disease, as evidenced by (1) mean UFC from two 24-hour urinary collections at least two times the upper limit of the laboratory normal range collected within 2 weeks; (2) morning plasma ACTH within the normal or above normal range; (3) either MRI confirmation of pituitary macroadenoma (greater than or equal to 1 cm) or inferior petrosal sinus gradient >3 after corticotrophin-releasing hormone (CRH) or for patients who have had prior pituitary surgery, documentation confirming an ACTH staining adenoma (an MRI is also required). This diagnosis must be verified within 2 months prior to study entry `Patients with de novo Cushing`s disease can be included only if they are not considered candidates for pituitary surgery (poor surgery candidates, surgically unapproachable tumors, patients who refuse to have surgical treatment) `Karnofsky performance status `?¥60 (i.e. requires occasional assistance, but is able to care for most of this personal needs) `For patients on medical treatment for Cushing`s disease the followingassessments are performed `Inhibitors of steroidogenesis - ketoconazole, metyrapone, rosiglitazone: 1 week `Dopamine agonists - bromocriptine, cabergoline: 4 weeks `Octreotide LAR and Lanreotide autogel: 8 weeks `Lanreotide SR: 4 weeks `Octreotide - immediate release formulation: 1 week
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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
`Patients who have received pituitary irradiation, as the onset time of the radiation effects can not be determined `Patients who have been treated with mitotane during the last 6 months `Patients with compression of the optic chiasm causing any visual field defect, in order to exclude patients with a tumor causing chiasma compression requiring surgery `Patients with Cushing`s syndrome due to ectopic ACTH secretion `Patients with hypercortisolism secondary to adrenal tumors or Nodular (primary) bilateral adrenal hyperplasia `Patients who have a known inherited syndrome as the cause for hormone over secretion (i.e. Carney Complex, McCune-Albright syndrome, MEN-1) `Patients with a diagnosis of glucocorticoid-remedial aldosteronism (GRA) `Patients who are not biochemically euthyroid `Patients who have undergone major surgery within 1 month `Patients with symptomatic cholelithiasis `Diabetic patients on antidiabetic medications whose fasting blood glucose is poorly controlled as evidenced by HbA1C >8% `Patients with abnormal coagulation (PT or PTT elevated by 30% above normal limits) `Patients receiving anticoagulants that affect PT or PTT `Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, symptomatic bradycardia, advanced heart block, history of acute MI less than one year prior to study entry or clinically significant impairment in cardiovascular function `Patients with liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis, or patients with ALT/AST more than 2 X ULN, serum creatinine >2.0 X ULN, serum bilirubin >2.0 X ULN, serum albumin >1.5 X ULN
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method