Status:
COMPLETED
GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids
Lead Sponsor:
Genelabs Technologies
Conditions:
Systemic Lupus Erythematosus
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Open label safety and efficacy follow-up.
Detailed Description
This was a randomized, multi-center, open-label, parallel-group, trial of prasterone 200 or 100 mg/day for 12 months in women with lupus receiving glucocorticoid therapy who had completed an earlier 6...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- Calcitonin
- Bisphosphonates
- 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
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00082511
Start Date
July 1 2003
End Date
August 1 2005
Last Update
January 14 2008
Active Locations (22)
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1
University of Arizona
Tucson, Arizona, United States, 85724
2
Wallace Rheumatic Study Center
Los Angeles, California, United States, 90048
3
Lifestyles Health Science Center
Rancho Mirage, California, United States, 92270
4
University of California San Diego
San Diego, California, United States, 92093-0943