GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids
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|ClinicalTrials.gov Identifier: NCT00082511|
Recruitment Status : Completed
First Posted : July 16, 2004
Last Update Posted : January 14, 2008
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|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Drug: Prasterone (GL701)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Center, Open-Label Study to Assess the Durability and Safety of the Prevention of Bone Loss by Treatment With GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||August 2005|
|Actual Study Completion Date :||August 2005|
- Drug: Prasterone (GL701)
There were 4 arms to the study:
During a previous 6 month db RCT, patients received either prasterone 200 mg/day or placebo. Upon entry into this open-label study, they were re-assigned by randomized allocation to receive either prasterone 200 mg/day or 100 mg/day. Hence, there were 4 possible treatment arms extending over the 18 months of observation between the double-blind study and the subsequent 12 month open-label extension study.
- Maintenance of bone mineral density (BMD) in women with systemic lupus erythematosus receiving glucocorticoids. [ Time Frame: 12 months ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- Patient has completed the full 6 month treatment period with study drug in the previous Genelabs' clinical study GL02-01.
- Concomitant treatment with prednisone (or equivalent) at a dose of ≥ 5mg/day.
- Patient has read and signed an Informed Consent Form. If the patient is not fluent in English, the Informed Consent must be signed in her native language.
- Patient has had a serious study drug related adverse reaction at any time during the previous GL02-01 study.
- 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).
MEDICATIONS PROHIBITED AT ANY TIME DURING THE STUDY
- Fluoride at pharmacologic dose
- Strontium at pharmacologic dose
- Estrogenic steroids (except oral contraceptives)
- Selective Estrogen Receptor Modulator (raloxifene)
- Parathyroid hormone
- Any androgens, including prescription or nutritional supplement DHEA, other than study drug
- Additional Calcium supplements other than those prescribed as part of this study
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): NCT00082511
|Responsible Party:||Kenneth E. Schwartz, MD, Genelabs Technologies, Inc.|
|Other Study ID Numbers:||
|First Posted:||July 16, 2004 Key Record Dates|
|Last Update Posted:||January 14, 2008|
|Last Verified:||January 2008|
Systemic Lupus Erythematosus
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Immune System Diseases
Physiological Effects of Drugs