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Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Mild to Moderate Systemic Lupus Erythematosus Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Mild to Moderate Systemic Lupus Erythematosus conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Mild to Moderate Systemic Lupus Erythematosus Clinical research trials and Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Mild to Moderate Systemic Lupus Erythematosus healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Mild to Moderate Systemic Lupus Erythematosus. Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Mild to Moderate Systemic Lupus Erythematosus Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Mild to Moderate Systemic Lupus Erythematosus clinical trial. Participants typically obtain the most effective healthcare available for their Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Mild to Moderate Systemic Lupus Erythematosus condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Mild to Moderate Systemic Lupus Erythematosus  Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Mild to Moderate Systemic Lupus Erythematosus
Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Mild to Moderate Systemic Lupus Erythematosus
For Condition: Systemic Lupus Erythematosus
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , Northwestern University
Synopsis: OBJECTIVES: I. Evaluate the safety and efficacy of synthetic dehydroepiandrosterone (GL701) in women with prednisone-dependent systemic lupus erythematosus. II. Describe the pharmacokinetics of GL701.
Details: PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution. Patients are randomly assigned to 1 of 2 doses of oral dehydroepiandrosterone or placebo, administered daily for a minimum of 7 months. A prednisone taper is attempted each month in patients with stable or improving disease. Therapy continues until a successful prednisone taper is achieved and sustained for at least 2 months, or until a maximum of 9 months. Patients are followed for 1 year after entry.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Systemic lupus erythematosus by American College of Rheumatology criteria Mild to moderate disease characterized as follows: Prednisone dose (or equivalent) 10 to 30 mg/day No daily dose 1 mg/kg or greater No alternate-day regimen Failed prednisone taper in last 12 months and dose stable for at least 6 weeks prior to entry OR No attempt to taper in last 12 months and dose stable for at least 3 months prior to entry No prior participation in double-blind dehydroepiandrosterone (DHEA) study at Stanford University --Prior/Concurrent Therapy-- No concurrent immunosuppressants No concurrent participation in other clinical studies No investigational agents within the longer of 30 days or 10 half lives of the agent At least 3 months since the following: Adrenocorticotropin hormone Androgens Cyclophosphamide Azathioprine Intravenous immune globulin Other immunosuppressants At least 1 month since any change in dose of concurrent nonsteroidal anti- inflammatory drugs or hydroxychloroquine --Patient Characteristics-- No hypersensitivity to DHEA or inactive ingredient in DHEA, i.e.: Cornstarch Lactose Magnesium stearate No condition that would prevent adequate compliance with study No history of breast cancer or reproductive tract malignancy Negative pregnancy test required within 2 weeks prior to entry Reliable contraception required of fertile women No estrogen-containing oral contraceptive
Total Enrollment: 190
Location and Contact Information:
Overall Study Official:
RosalindRamsey-Goldman, Study Chair, Northwestern University
Additional Information:
Study ID Numbers: 199/11930; NU-517
Study Start Date: August 1994
Record last reviewed: December 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004795
Other Systemic Lupus Erythematosus Studies:
1. Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Active Systemic Lupus Erythematosus
2. Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases
3. Psychoeducational Approach to Improve Health in Lupus
4. Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody Syndrome
5. Phase II Study of Long-Term Dehydroepiandrosterone for Systemic Lupus Erythematosus
Related Studies:
Other Systemic Lupus Erythematosus Clinical Trials
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Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Mild to Moderate Systemic Lupus Erythematosus
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