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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics
ClinicalTrials.gov Identifier:
NCT00796783
First received: November 20, 2008
Last updated: June 19, 2014
Last verified: June 2014

November 20, 2008
June 19, 2014
February 2009
June 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00796783 on ClinicalTrials.gov Archive Site
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A Study to Confirm Recurrent or Persistent Cushing's Syndrome in Patients With Signs or Symptoms of Hypercortisolemia
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

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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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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.

Cushing's Syndrome
Drug: Cushing's syndrome confirmation
Other Name: Provide access to standard test procedures.
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.
Intervention: Drug: Cushing's syndrome confirmation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
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June 2010   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00796783
C-1073-410
No
Corcept Therapeutics
Corcept Therapeutics
Not Provided
Study Director: Coleman Gross, MD Corcept Therapeutics
Corcept Therapeutics
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP