A Study to Confirm Recurrent or Persistent Cushing's Syndrome in Patients With Signs or Symptoms of Hypercortisolemia
This study has been terminated.
Information provided by (Responsible Party):
First received: November 20, 2008
Last updated: February 24, 2014
Last verified: December 2010
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.
||Observational Model: Case-Only
Time Perspective: Prospective
||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
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 ]
| Study Start Date:
| 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00796783
|AMCR Institute Inc.
|Escondido, California, United States, 92026 |
|The Center for Diabetes and Endocrine Care
|Hollywood, Florida, United States, 33021 |
|Diabetes and Glandular Disease Research
|San Antonio, Texas, United States, 78229 |
||Coleman Gross, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 20, 2008
||February 24, 2014
||United States: Food and Drug Administration
Keywords provided by Corcept Therapeutics:
Ectopic ACTH Secretion
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 17, 2014
Pituitary ACTH Hypersecretion
Adrenal Gland Diseases
Endocrine System Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs