A Study to Confirm Recurrent or Persistent Cushing's Syndrome in Patients With Signs or Symptoms of Hypercortisolemia

Stopped early

Conditions studied: Cushing's Syndrome

In brief

This is an observational study to confirm the presence of recurrent or persistent endogenous Cushing's syndrome in patients who have had primary surgical and/or radiation therapy for Cushing's disease and continue to manifest symptoms and signs of hypercortisolemia.

Key facts

Study ID

NCT00796783

Run by

Corcept Therapeutics

People needed

2

Starts

2009-02-01

Last updated by the study team

2014-06-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Are at least 18 years of age.
• Have a presumptive diagnosis of Cushing's disease (Cushing's syndrome due to an ACTH secreting pituitary tumor).
• Have previously had pituitary surgery and/or pituitary radiation with the intent of curing or treating Cushing's disease.
• Have clinical symptoms and signs of hypercortisolism.
• Are able to provide written informed consent.
• Are expected to complete the study.

You may not qualify if…

• Are surgical candidates for pituitary surgery or have had pituitary surgery within 8 weeks before screening.
• Have taken any medication that may interfere with protocol testing procedures within 30 days of initial screening (phenobarbital, phenytoin, carbamazepine, oxcarabazepine, primidone, rifampin, rifapentine, rifabutin, ethosuximide, pioglitazone, efavirenz, neviparine, modafinil, St. Johns wort, glucorticoids, estrogen containing oral contraceptives).
• Have received investigational treatment (drug, biologic agent or device) within 30 days of screening.
• Have a non-endogenous source of hypercortisolemia such as factitious hypercortisolemia (exogenous source of glucocorticoid, iatrogenic Cushing's syndrome), factitious or therapeutic use of ACTH.
• Have Pseudo-Cushing's syndrome. Subjects with suspected Pseudo-Cushing's syndrome such as those with severe obesity, major depression or a history of alcoholism.
• Uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
• Have renal failure as defined by a serum creatinine of 202 mg/dL.
• Elevated total bilirubin (>1.5x ULN), elevated ALT(>3x ULN) or AST (>3x ULN).

Where it is running

• AMCR Institute Inc. — Escondido, California, United States
• The Center for Diabetes and Endocrine Care — Hollywood, Florida, United States
• Diabetes and Glandular Disease Research — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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