GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids

This study has been completed.
Sponsor:
Information provided by:
Genelabs Technologies
ClinicalTrials.gov Identifier:
NCT00082511
First received: May 11, 2004
Last updated: January 10, 2008
Last verified: January 2008

May 11, 2004
January 10, 2008
July 2003
August 2005   (final data collection date for primary outcome measure)
Maintenance of bone mineral density (BMD) in women with systemic lupus erythematosus receiving glucocorticoids. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00082511 on ClinicalTrials.gov Archive Site
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GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids
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

Open label safety and efficacy follow-up.

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-month randomized, placebo-controlled study (NCT00053560. Bone Mineral Density assessments were performed at baseline and at months 6 and 12.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Systemic Lupus Erythematosus
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.

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Sánchez-Guerrero J, Fragoso-Loyo HE, Neuwelt CM, Wallace DJ, Ginzler EM, Sherrer YR, McIlwain HH, Freeman PG, Aranow C, Petri MA, Deodhar AA, Blanton E, Manzi S, Kavanaugh A, Lisse JR, Ramsey-Goldman R, McKay JD, Kivitz AJ, Mease PJ, Winkler AE, Kahl LE, Lee AH, Furie RA, Strand CV, Lou L, Ahmed M, Quarles B, Schwartz KE. Effects of prasterone on bone mineral density in women with active systemic lupus erythematosus receiving chronic glucocorticoid therapy. J Rheumatol. 2008 Aug;35(8):1567-75. Epub 2008 Jul 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
114
August 2005
August 2005   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Mexico
 
NCT00082511
GL03-01
No
Kenneth E. Schwartz, MD, Genelabs Technologies, Inc.
Genelabs Technologies
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Genelabs Technologies
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP