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| Sponsor: | Corcept Therapeutics |
|---|---|
| Information provided by: | 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: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2007 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
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.
|
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| Contact: Chris Ward, Sponsor Contact | 650-688-8807 | cward@corcept.com |
| United States, Alabama | |
| University of Alabama at Birmingham School of Medicine | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Marianne M Vetrano, RN 205-934-4112 mvetrano@uab.edu | |
| Principal Investigator: T. Brooks Vaughan, III, MD | |
| United States, California | |
| AMCR Institute Inc. | Recruiting |
| Escondido, California, United States, 92026 | |
| Contact: Laura Bedolla, CCRC 760-466-1523 lbedolla@amcrinstitute.com | |
| Principal Investigator: Timothy S Bailey, MD | |
| University of California San Francisco | Withdrawn |
| San Francisco, California, United States, 94143 | |
| Stanford University Medical Center | Recruiting |
| Stanford, California, United States, 94305-5826 | |
| Contact: Kathleen Biederman, RN 650-721-6188 ktbieder@stanford.edu | |
| Principal Investigator: Laurence Katznelson, MD | |
| United States, Colorado | |
| University of Colorado Health Science Center at Fitzsimon | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Jennifer Tryggestad, MSSW 720-848-2692 jennifer.tryggestad@ucdenver.edu | |
| Principal Investigator: Janice Kerr, MD | |
| United States, Florida | |
| The Center for Diabetes and Endocrine Care | Recruiting |
| Hollywood, Florida, United States, 33021 | |
| Contact: Carrie-Ann Silva 954-963-7191 ext 243 casilvia@bellsouth.net | |
| Principal Investigator: Sam Lerman, MD | |
| United States, Illinois | |
| Northwestern University Feinberg Medical; Division of Endocrinology, Metabolism & Molecular Medicine | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Daphne Adelman, RN, MBA 312-908-9002 d-adelman@northwestern.edu | |
| Principal Investigator: Mark Molitch, MD | |
| The University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Catherine DeSandre 773-834-0577 cdesandr@medicine.bsd.uchicago.edu | |
| Principal Investigator: Roy E Weiss, MD | |
| United States, Maryland | |
| Sinai Hospital of Baltimore | Recruiting |
| Baltimore, Maryland, United States, 21215 | |
| Contact: Alan Orpia, BSN, RN 410-601-0960 Aorpia@lifebridgehealth.org | |
| Principal Investigator: Henry G Fein, MD | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Karen Pulaski-Liebert, BSN, RN 617-726-7473 kliebert@partners.org | |
| Principal Investigator: Beverly Biller, MD | |
| United States, Michigan | |
| University of Michigan Medical Center | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Virginia E Uhley, PhD, RD 734-232-3618 vuhley@med.umich.edu | |
| Principal Investigator: David Schteingart, MD | |
| United States, Mississippi | |
| University of Mississippi Medical Center | Recruiting |
| Jackson, Mississippi, United States, 39216 | |
| Contact: Sheila Belk 601-815-5374 sbelk@medicine.umsmed.edu | |
| Principal Investigator: Christian A Koch, MD | |
| United States, New Mexico | |
| University of New Mexico HSC | Recruiting |
| Albuquerque, New Mexico, United States, 87131 | |
| Contact: Sofia Ramirez 505-275-7667 SoRamirez@salud.unm.edu | |
| Principal Investigator: Kathleen Colleran, MD | |
| United States, Ohio | |
| Cleveland Clinic Foundation; Dept of Endocrinology, Diabetes & Metabolism | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Jackie Payne, RN 216-444-3694 paynej3@ccf.org | |
| Sub-Investigator: Amir Hekmat Hamrahian, MD | |
| Ohio State University Medical Center | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Katie Schweinsberg, RN 614-688-5881 kathleen.schweinsberg@osumc.edu | |
| Principal Investigator: Lawrence Steven Kirschner, MD, PhD | |
| United States, Oklahoma | |
| Oklahoma University Health Science Center | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Sharon Buckley, RN, CDE 405-271-2814 sharon-buckley@ouhsc.edu | |
| Principal Investigator: Timothy Lyons, MD | |
| United States, Oregon | |
| Oregon Health Sciences University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Chris Yedinak, MN, CFNP 503-494-6576 yedinakc@ohsu.edu | |
| Principal Investigator: Maria G Fleseriu, MD | |
| United States, Texas | |
| Diabetes and Glandular Disease Clinic | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Cheryl Sheets, RN, CCRC 210-615-5569 cheryl.sheets@cetero.com | |
| Principal Investigator: Mark Kipnes, MD | |
| University of Texas Southwestern Medical Center | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Amit Gode 214-648-0417 Amit.Gode@utsouthwestern.edu | |
| Principal Investigator: Michael J McPhaul, MD | |
| United States, Wisconsin | |
| Endocrinology Center at North Hills, Froedtert and Medical College of Wisconsin | Recruiting |
| Menomonee Falls, Wisconsin, United States, 53051 | |
| Contact: Gerard Coly, MD 414-456-7467 gcoly@mcw.edu | |
| Principal Investigator: Maria Grama Findling, MD | |
| Study Director: | Coleman Gross | Corcept Therapeutics |
More Information
| Responsible Party: | Corcept Therapeutics ( Coleman Gross ) |
| Study ID Numbers: | C-1073-400 |
| Study First Received: | December 5, 2007 |
| Last Updated: | November 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00569582 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Pituitary Cushing's Disease Cushing's Syndrome Cushings 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 |
|
Contraceptives, Postcoital, Synthetic Contraceptive Agents Hormone Antagonists Physiological Effects of Drugs Contraceptives, Oral Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Adrenal Gland Diseases Reproductive Control Agents Hormones Adrenocortical Hyperfunction Adrenocorticotropic Hormone Pathologic Processes |
Syndrome Therapeutic Uses Abortifacient Agents Menstruation-Inducing Agents Contraceptives, Oral, Synthetic Abortifacient Agents, Steroidal Disease Cushing Syndrome Endocrine System Diseases Mifepristone Contraceptives, Postcoital Luteolytic Agents Pharmacologic Actions |