Study of GL701 in Men With Systemic Lupus Erythematosus

June 23, 2005 updated by: Genelabs Technologies
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Redwood City, California, United States, 94063
        • Genelabs Technologies, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genelabs Technologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1998

Study Registration Dates

First Submitted

May 16, 2002

First Submitted That Met QC Criteria

May 16, 2002

First Posted (Estimate)

May 17, 2002

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

May 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GL97-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Systemic Lupus Erythematosus

Clinical Trials on GL701

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe