An Extension Study of CORLUX in the Treatment of Endogenous Cushing's Syndrome
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ClinicalTrials.gov Identifier: NCT00936741 |
Recruitment Status :
Completed
First Posted : July 10, 2009
Results First Posted : April 2, 2014
Last Update Posted : April 2, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cushing's Syndrome | Drug: mifepristone | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open Label Extension Study of the Efficacy and Safety of CORLUX® (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's Syndrome |
Study Start Date : | July 2009 |
Actual Primary Completion Date : | September 2012 |
Actual Study Completion Date : | September 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: Mifepristone
Mifepristone 300mg to 1200mg once daily
|
Drug: mifepristone
Mifepristone 300 mg to 1200 mg once daily
Other Name: CORLUX |
- Number of Participants With Adverse Events [ Time Frame: Up to three years. ]Subjects who received at least one dose of mifepristone were included in the safety analysis.
- The Long-term Benefit of Mifepristone Treatment in Cushing's Syndrome as Measured by Changes in the Score on the Physician's Global Assessment of Disease Severity [ Time Frame: Up to three years. ]
The mean Investigator's rating of the change in subject's signs and symptoms of Cushing's syndrome from Baseline (Entry into C1073-415) to Endpoint on the Physician's Global Assessment of Disease Severity was ranked on a 9-point scale (9 = much worse, 7 = worse, 5 = no change, 3 = better, 1 = much better). Higher scores indicate more severe illness. Scoring was done at all visits except the 6 Week Follow-up visit; the final visit result (Endpoint) is reported here.
The instruction was "Rate the change in the subject's signs and symptoms of Cushing's from Baseline (1 = much better to 9 = much worse)".
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Have completed the Week 24 visit and the 6-Week Follow-up visit of Corcept Study C-1073-400 (NCT00569582).
- In the opinion of the Investigator, are expected to maintain clinical benefit from mifepristone.
- Women of childbearing potential have a negative serum pregnancy test at Entry.
- Women of childbearing potential must be willing to use non-hormonal, medically acceptable methods of contraception during the study.
- Are able to provide written informed consent
- Are able to return to the investigative site to complete the study evaluations outlined in the protocol.
- Will not use systemic estrogens during the study.
Exclusion Criteria:
- Have an acute or unstable medical problem, which could be aggravated by mifepristone treatment.
- Are taking medications within 14 days of the Entry visit that a) have a large first pass metabolism that is largely mediated by CYP3A4 and which have a narrow therapeutic margin; and/or b) are strong CYP3A4 inhibitors.
- Female patients of reproductive potential, who are pregnant or who are unable or unwilling to use medically acceptable, non-hormonal methods of contraception during the study.
- Have received investigational treatment (drug, biological agent or device) other than CORLUX (mifepristone) within 30 days of Entry
- Have a history of an allergic reaction or intolerance to CORLUX (mifepristone)
- Have uncorrected hypokalemia (potassium level of <3.5 mEq/L) at Entry. Spironolactone or eplerenone is allowed to control hypokalemia.
- Postmenopausal women with a history of endometrial hyperplasia with atypia or pathological features consistent with endometrial carcinoma.
- Thickened endometrium on the Entry Visit transvaginal ultrasound that has not resolved after induction of menstrual bleeding with progesterone.
- Uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
- Any woman with an intact uterus who has a hemorrhagic disorder or is being treated with an anticoagulant (e.g. warfarin, heparin).
- Have renal failure as defined by a serum creatinine of ≥2.2 mg/dL.
- Elevated total bilirubin >1.5 ULN, elevated ALT or AST ≥3X the upper limit of normal.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00936741
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 | |
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 | |
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 Diabetes 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, 75390-8857 | |
United States, Wisconsin | |
Endocrinology Center at Community Medical Commons | |
Menomonee Falls, Wisconsin, United States, 53051 |
Study Director: | Coleman Gross, MD | Corcept Therapeutics |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Corcept Therapeutics |
ClinicalTrials.gov Identifier: | NCT00936741 |
Other Study ID Numbers: |
C-1073-415 |
First Posted: | July 10, 2009 Key Record Dates |
Results First Posted: | April 2, 2014 |
Last Update Posted: | April 2, 2014 |
Last Verified: | February 2014 |
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 Syndrome Disease Pathologic Processes Adrenocortical Hyperfunction Adrenal Gland Diseases Endocrine System Diseases Mifepristone Abortifacient Agents, Steroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs |
Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Contraceptives, Postcoital, Synthetic Contraceptives, Postcoital Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Luteolytic Agents Contraceptive Agents, Hormonal Menstruation-Inducing Agents |