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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:
Corcept Therapeutics
ClinicalTrials.gov Identifier:
NCT00796783
First received: November 20, 2008
Last updated: December 16, 2010
Last verified: December 2010
History of Changes
  Purpose

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.


Condition
Cushing's Syndrome

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Estimated Enrollment: 150
Study Start Date: February 2009
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00796783

Locations
United States, California
AMCR Institute Inc.
Escondido, California, United States, 92026
United States, Florida
The Center for Diabetes and Endocrine Care
Hollywood, Florida, United States, 33021
United States, Texas
Diabetes and Glandular Disease Research
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Corcept Therapeutics
Investigators
Study Director: Coleman Gross, MD Corcept Therapeutics
  More Information

No publications provided

Responsible Party: Coleman Gross, MD, Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT00796783     History of Changes
Other Study ID Numbers: C-1073-410
Study First Received: November 20, 2008
Last Updated: December 16, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Corcept Therapeutics:
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

Additional relevant MeSH terms:
Cushing Syndrome
Pituitary ACTH Hypersecretion
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013