Tuesday, December 23, 2008

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

http://clinicaltrials.gov/ct2/show/NCT00796783

ClinicalTrials.gov Identifier:
NCT00796783

  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

MedlinePlus related topics: Cushing's Syndrome

Drug Information available for: Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC Corticotropin Epinephrine Epinephrine bitartrate

U.S. FDA Resources

Study Type:

Observational

Study Design:

Case-Only, 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

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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:

150

Study Start Date:

January 2009

Estimated Study Completion Date:

June 2010

Estimated 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

Contacts

Contact: Patti Cronin
650-688-8810
pcronin@corcept.com

Sponsors and Collaborators

Corcept Therapeutics

Investigators

Study Director:
Coleman Gross, MD
Corcept Therapeutics

  More Information

Responsible Party:

Corcept Therapeutics ( Coleman Gross, MD )

Study ID Numbers:

C-1073-410

First Received:

November 20, 2008

Last Updated:

November 20, 2008

ClinicalTrials.gov Identifier:

NCT00796783 [history]

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
Cushing's Disease
Cortisol
Ectopic ACTH Secretion

Study placed in the following topic categories:

Hypothalamic Diseases
Hydrocortisone
Cortisol succinate
Facies
Pituitary Diseases
Cushing Syndrome
Central Nervous System Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Brain Diseases
Cardiac Complexes, Premature

Adrenocortical Hyperfunction
Adrenocorticotropic Hormone
Recurrence
Carcinoma
Pituitary ACTH Hypersecretion
Hirsutism
Hydrocortisone acetate
Endocrinopathy
Epinephrine
Adenoma

Additional relevant MeSH terms:

Hyperpituitarism
Pathologic Processes
Disease
Syndrome
Nervous System Diseases

ClinicalTrials.gov processed this record on December 22, 2008