|
Study of GL701 in Men with Systemic Lupus Erythematosus Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Study of GL701 in Men with Systemic Lupus Erythematosus conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Study of GL701 in Men with Systemic Lupus Erythematosus Clinical research trials and Study of GL701 in Men with Systemic Lupus Erythematosus healthcare trials happen in many of places across 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 effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Study of GL701 in Men with Systemic Lupus Erythematosus. Study of GL701 in Men with Systemic Lupus Erythematosus Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Study of GL701 in Men with Systemic Lupus Erythematosus clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Study of GL701 in Men with Systemic Lupus Erythematosus condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "S" Clinical Trials Conditions > Study of GL701 in Men with Systemic Lupus Erythematosus  Study of GL701 in Men with Systemic Lupus Erythematosus
Study of GL701 in Men with Systemic Lupus Erythematosus
For Condition: Systemic Lupus Erythematosus
Status: No longer recruiting
Sponsor(s): Genelabs Technologies ,
Synopsis: Lupus flares and other symptoms associated with systemic lupus erythematosus (SLE) may be caused by a deficiency of dehydroepiandrosterone (DHEA). GL701 is an investigational new drug meant to enhance DHEA levels. This study is designed to evaluate both the safety and efficacy of GL701 in male lupus patients.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Male
Protocol Entry Criteria: Inclusion Criteria - Patient must have a diagnosis of SLE > 6 months according to the 1989 revised ACR criteria. Patient must meet at least four of the eleven ACR criteria for systemic lupus - Patient must have a modified SLEDAI score > 3 at both screening and qualifying visits (Appendix A-2) - Patient must be treated for SLE with doses of prednisone < 30 mg/day (including those on NO glucocorticoid therapy) unchanged for > 6 weeks prior to study entry (including both screening and qualifying visits). Prednisone dose in patient's receiving alternate day therapy will be the mean daily prednisone dose - Patient treated with azathioprine, methotrexate, or hydrochloroquine must be on a stable dose with no change in dose for at least 6 weeks preceding the study - Patient must be able to read and speak English and willing to sign an informed consent in English Exclusion Criteria - Patient with a history of prostate cancer - Patient with elevated Prostate Specific Antigen (PSA) - Patient diagnosed with liver disease, defined as AST or ALT > 3x the upper limit of normal - Patient ingesting body building/anabolic steroids within the last 6 months preceding the study - Patient with end stage renal disease or receiving hemodialysis treatment - Patient with serum creatinine > 2 mg/dl or creatinine clearance < 60 ml/min - Patient receiving treatment with ACTH within the 3 months preceding study entry - Patient receiving androgens, immunoglobulins, cyclophosphamide, cyclosporin A, or other immunosuppressive agents, except azathioprine, methotrexate, and hydrochloroquine within the last 3 months - Patient with known hypersensitivity to DHEA or the inactive ingredients used in the GL70l formulation (cornstarch, lactose, and magnesium stearate) - Patient who participated in any prior DHEA study or administration of DHEA within the past 3 months - Patient using any investigational agents within the longer of 30 days or 10 half-lives of the agent - Patient with any condition which in the Investigator's or sponsor's opinion is sufficient to prevent adequate compliance with the study or likely to confuse follow-up evaluation (e.g.. alcoholism, drug addiction, acute withdrawal from chemical dependency, psychiatric disease) - Patient requires treatment/medication prohibited by protocol - Patient with any serious EKG abnormality as determined by the Investigator
Total Enrollment: 40
Location and Contact Information:
Genelabs Technologies, Inc.
Redwood City, California, 94063
United States
Additional Information:
Study ID Numbers: GL97-01;
Study Start Date: March 1998
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00037128
Other Systemic Lupus Erythematosus Studies:
1. Epidemiologic Study of Reproductive Outcome in Women with Systemic Lupus Erythematosus
2. Study of GL701 in Men with Systemic Lupus Erythematosus
3. Phase II Study of Long-Term Dehydroepiandrosterone for Systemic Lupus Erythematosus
4. Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody Syndrome
5. Safety and Efficacy Study of LJP 394 (abetimus sodium) to treat lupus kidney disease
Related Studies:
Other Systemic Lupus Erythematosus Clinical Trials
Other California Clinical Trials
Other Redwood City Clinical Trials
Study of GL701 in Men with Systemic Lupus Erythematosus
|
|
|
|
|
|
|
|
