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

Cushing's Syndrome Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00796783
• Other study ID #: C-1073-410
• 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. 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

Related Conditions & MeSH terms

• Adrenocortical Hyperfunction
• Cushing Syndrome
• Cushing's Syndrome
• Syndrome

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