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.
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
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)
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:
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
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