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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00082511 |
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Date of registration:
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11/05/2004 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids
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Scientific title:
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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 |
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Date of first enrolment:
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July 2003 |
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Target sample size:
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114 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00082511 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Mexico
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Drug: Prasterone (GL701)
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Primary Outcome(s)
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Maintenance of bone mineral density (BMD) in women with systemic lupus erythematosus receiving glucocorticoids.
[Time Frame: 12 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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