Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Corcept Therapeutics |
---|---|
Information provided by: | Corcept Therapeutics |
ClinicalTrials.gov Identifier: | NCT00569582 |
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 Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 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.
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:
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 650-688-8807 | |
Principal Investigator: T. Brooks Vaughan, III, MD | |
United States, California | |
AMCR Institute Inc. | Recruiting |
Escondido, California, United States, 92026 | |
Contact 650-688-8807 | |
Principal Investigator: Timothy S Bailey, MD | |
University of California San Francisco | Recruiting |
San Francisco, California, United States, 94143 | |
Contact 650-688-8807 | |
Principal Investigator: Lewis Blevins, MD | |
United States, Colorado | |
University of Colorado Health Science Center at Fitzsimon | Recruiting |
Aurora, Colorado, United States, 80045 | |
Contact 650-688-8807 | |
Principal Investigator: Janice Kerr, MD | |
United States, Florida | |
The Center for Diabetes and Endocrine Care | Recruiting |
Hollywood, Florida, United States, 33021 | |
Contact 650-688-8807 | |
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 650-688-8807 | |
Principal Investigator: Mark Molitch, MD | |
The University of Chicago | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact 650-688-8807 | |
Principal Investigator: Roy E Lyons, MD | |
United States, Michigan | |
University of Michigan Medical Center | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact 650-688-8807 | |
Principal Investigator: David Schteingart, MD | |
United States, Ohio | |
Cleveland Clinic Foundation; Dept of Endocrinology, Diabetes & Metabolism | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact 650-688-8807 | |
Sub-Investigator: Amir Hekmat Hamrahian, MD | |
Ohio State University Medical Center | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact 650-688-8807 | |
Principal Investigator: Lawrence Steven Kirschner, MD, PhD | |
United States, Oklahoma | |
Oklahoma University Health Science Center | Recruiting |
Oklahoma City, Oklahoma, United States, 73104 | |
Contact 650-688-8807 | |
Principal Investigator: Timothy Lyons, MD | |
United States, Oregon | |
Oregon Health Sciences University | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact 650-688-8807 | |
Principal Investigator: Maria G Fleseriu, MD | |
United States, Texas | |
Diabetes and Glandular Disease Clinic | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact 650-688-8807 | |
Principal Investigator: Mark Kipnes, MD |
Study Director: | Coleman Gross | Corcept Therapeutics |
Responsible Party: | Corcept Therapeutics ( Coleman Gross ) |
Study ID Numbers: | C-1073-400 |
Study First Received: | December 5, 2007 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00569582 |
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 Cushinoid |
Moon facies Dorsalcervical fat Plethora Hirsutism Violaceous striae Hormone Contraceptive Endocrine Cushing Syndrome Cushing's Disease Cortisol Ectopic ACTH Secretion |
Hydrocortisone Facies Cortisol succinate Cushing Syndrome Adrenal Gland Diseases Endocrine System Diseases Mifepristone Cardiac Complexes, Premature Adrenocortical Hyperfunction |
Adrenocorticotropic Hormone Carcinoma Pituitary ACTH Hypersecretion Hirsutism Signs and Symptoms Hydrocortisone acetate Endocrinopathy Epinephrine Adenoma |
Abortifacient Agents, Steroidal Contraceptives, Postcoital, Synthetic Disease Contraceptive Agents Hormone Antagonists Contraceptives, Oral Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Reproductive Control Agents |
Luteolytic Agents Contraceptives, Postcoital Pharmacologic Actions Pathologic Processes Syndrome Therapeutic Uses Abortifacient Agents Menstruation-Inducing Agents Contraceptives, Oral, Synthetic |