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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00796783 |
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Date of registration:
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20/11/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study to Confirm Recurrent or Persistent Cushing's Syndrome in Patients With Signs or Symptoms of Hypercortisolemia
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Scientific title:
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A Study to Confirm the Presence of Recurrent or Persistent Cushing's Syndrome in Patients With Clinical Signs or Symptoms of Hypercortisolemia Who Have Been Treated for Cushing's Disease |
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Date of first enrolment:
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February 2009 |
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Target sample size:
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2 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00796783 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Coleman Gross, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Corcept Therapeutics |
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Key inclusion & exclusion 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).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cushing's Syndrome
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Intervention(s)
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Drug: Cushing's syndrome confirmation
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Primary Outcome(s)
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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.
[Time Frame: up to 16 weeks]
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Secondary ID(s)
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C-1073-410
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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