Study of GL701 in Men With Systemic Lupus Erythematosus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2004 by Genelabs Technologies.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Genelabs Technologies
ClinicalTrials.gov Identifier:
NCT00037128
First received: May 16, 2002
Last updated: December 8, 2005
Last verified: May 2004
  Purpose

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.


Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: GL701
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Genelabs Technologies:

Estimated Enrollment: 40
Study Start Date: March 1998
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00037128

Locations
United States, California
Genelabs Technologies, Inc.
Redwood City, California, United States, 94063
Sponsors and Collaborators
Genelabs Technologies
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00037128     History of Changes
Other Study ID Numbers: GL97-01
Study First Received: May 16, 2002
Last Updated: December 8, 2005
Health Authority: Unspecified

Keywords provided by Genelabs Technologies:
Lupus
SLE
DHEA
GL701

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014