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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00796783
Other study ID # C-1073-410
Secondary ID
Status Terminated
Phase N/A
First received November 20, 2008
Last updated June 19, 2014
Start date February 2009

Study information

Verified date June 2014
Source Corcept Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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).

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Intervention

Drug:
Cushing's syndrome confirmation


Locations

Country Name City State
United States 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

Sponsors (1)

Lead Sponsor Collaborator
Corcept Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. up to 16 weeks No
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Recruiting NCT02019706 - Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome Phase 2