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.
Drug Information available for: Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC Corticotropin Epinephrine Epinephrine bitartrate
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
Further study details as provided by Corcept Therapeutics:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: None Retained
Study Start Date:
Estimated Study Completion Date:
Estimated Primary Completion Date:
June 2010 (Final data collection date for primary outcome measure)
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.
Ages Eligible for Study:
18 Years and older
Genders Eligible for Study:
Accepts Healthy Volunteers:
Patients with presumed Cushing's disease who have failed pituitary surgery and/or radiation and require adjuvant medical treatment for recurrent or persistent Cushing's syndrome.
- 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.
- 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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00796783
Contact: Patti Cronin
Sponsors and Collaborators
Coleman Gross, MD
Corcept Therapeutics ( Coleman Gross, MD )
Study ID Numbers:
November 20, 2008
November 20, 2008
United States: Food and Drug Administration
Keywords provided by Corcept Therapeutics:
Ectopic ACTH Secretion
Study placed in the following topic categories:
Central Nervous System Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Cardiac Complexes, Premature
Pituitary ACTH Hypersecretion
Additional relevant MeSH terms:
Nervous System Diseases
ClinicalTrials.gov processed this record on December 22, 2008