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| Sponsor: | Corcept Therapeutics |
|---|---|
| Information provided by (Responsible Party): | Corcept Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00569582 |
Purpose
Patients will receive Corlux (mifepristone) daily for up to 24 weeks. Assessments of the signs and symptoms of Cushing's syndrome will be obtained.
| Condition | Intervention | Phase |
|---|---|---|
|
Cushing's Syndrome |
Drug: mifepristone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label Study of the Efficacy and Safety of CORLUX (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's Syndrome |
| Enrollment: | 50 |
| Study Start Date: | December 2007 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: mifepristone
Patients take mifepristone by mouth once a day. The dose is increased during scheduled timepoints during the study or until symptoms improve or the highest dosage allowed is reached. Dose escalation will be based upon weight. During clinic visits, blood pressure, glucose tolerance and blood chemistries are measured and EKG and urinalysis will be performed.
Other Name: CORLUX
|
Cushing's syndrome is a relatively rare disorder caused by prolonged exposure to high levels of the glucocorticoid hormone cortisol. Cushing's syndrome may result from elevated endogenous or exogenous sources of cortisol. Endogenous Cushing's syndrome resulting from cortisol overproduction by the adrenal glands is the subject of this protocol. Patients with exogenous Cushing's syndrome, which develops as a side effect of chronic administration of high doses of glucocorticoids, are not eligible for enrollment in this study.
This will evaluate the safety and efficacy of mifepristone for treatment of the signs and symptoms of hypercortisolemia in patients with endogenous Cushing's syndrome from ACTH-dependent or adrenal disorders.
The study will enroll subjects for whom the investigator has determined that medical treatment of endogenous hypercortisolemia is needed. Medical treatment may be intended to treat the effects of persistent or recurrent hypercortisolemia after surgery and/or radiation for Cushing's syndrome, to bridge the period of time for radiation to become effective, or when surgery is not feasible.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Individuals eligible for enrollment into this study are adult male and non-pregnant female adult patients who:
Have a confirmed diagnosis of endogenous hypercortisolemia caused by ACTH dependent or ACTH independent etiologies, including
Exclusion Criteria:
Individuals not eligible to be enrolled into the study are those who:
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham School of Medicine | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| AMCR Institute Inc. | |
| Escondido, California, United States, 92026 | |
| Stanford University Medical Center | |
| Stanford, California, United States, 94305-5826 | |
| United States, Florida | |
| The Center for Diabetes and Endocrine Care | |
| Hollywood, Florida, United States, 33021 | |
| United States, Illinois | |
| Northwestern University Feinberg Medical; Division of Endocrinology, Metabolism & Molecular Medicine | |
| Chicago, Illinois, United States, 60611 | |
| The University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Maryland | |
| Sinai Hospital of Baltimore | |
| Baltimore, Maryland, United States, 21215 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| University of Michigan Medical Center | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216 | |
| United States, New Mexico | |
| University of New Mexico HSC | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, Ohio | |
| Cleveland Clinic Foundation; Dept of Endocrinology, Diabetes & Metabolism | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oklahoma | |
| Oklahoma University Health Science Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Oregon Health Sciences University | |
| Portland, Oregon, United States, 97239 | |
| United States, Texas | |
| University of Texas Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
| Diabetes and Glandular Disease Clinic | |
| San Antonio, Texas, United States, 78229 | |
| United States, Wisconsin | |
| Endocrinology Center at North Hills, Froedtert and Medical College of Wisconsin | |
| Menomonee Falls, Wisconsin, United States, 53051 | |
| Study Director: | Coleman Gross | Corcept Therapeutics |
More Information
| Responsible Party: | Corcept Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00569582 History of Changes |
| Other Study ID Numbers: | C-1073-400 |
| Study First Received: | December 5, 2007 |
| Last Updated: | November 29, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Cushing's Disease Cushing's Syndrome Cushings Pituitary ACTH Adrenocorticotropic hormone Ectopic Adrenal adenoma Adrenal carcinoma Adrenal autonomy Cortisol Hypercortisolemia |
Cushingoid Moon facies Dorsocervical fat Plethora Hirsutism Violaceous striae Hormone Contraceptive Endocrine Cushing Syndrome Ectopic ACTH Secretion |
|
Cushing Syndrome Adrenocortical Hyperfunction Adrenal Gland Diseases Endocrine System Diseases Adrenocorticotropic Hormone Mifepristone Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Contraceptives, Oral, Synthetic Contraceptives, Oral |
Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptives, Postcoital, Synthetic Contraceptives, Postcoital Hormone Antagonists Luteolytic Agents Menstruation-Inducing Agents Abortifacient Agents, Steroidal Abortifacient Agents |