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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Cushing's Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients with presumed Cushing's disease who have failed pituitary surgery and/or radiation and require medical treatment for recurrent or persistent Cushing's syndrome.

Cushing's syndrome confirmation

Intervention Type DRUG

Interventions

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Cushing's syndrome confirmation

Intervention Type DRUG

Other Intervention Names

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Provide access to standard test procedures.

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No