Clinical trial NCT00796783: A Study to Confirm Recurrent or Persistent Cushing's Syndrome in Patients With Signs or Symptoms of Hypercortisolemia
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cushing's Syndrome
Keywords: Cushing's Disease
Cushing's Syndrome
Cushings
Pituitary
ACTH
Adrenocorticotropic hormone
Ectopic
Adrenal adenoma
Adrenal carcinoma
Adrenal autonomy
Cortisol
Hypercortisolemia
Cushinoid
Moon facies
Dorsalcervical fat
Plethora
Hirsutism
Violaceous striae
Hormone
Contraceptive
Endocrine
Cushing Syndrome
Ectopic ACTH Secretion
Lead sponsor: Corcept Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-11-24
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
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.
timeFrame: up to 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute Inc.
state: California
city: Hollywood
country: United States
facility: The Center for Diabetes and Endocrine Care
state: Florida
city: San Antonio
country: United States
facility: Diabetes and Glandular Disease Research
state: Texas
Study officials:
affiliation: Corcept Therapeutics
name: Coleman Gross, MD
role: STUDY_DIRECTOR
References: