Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004662
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase III Randomized Double-Blind Placebo-Controlled Study of Dehydroepiandrosterone in Women With Active Systemic Lupus Erythematosus
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES
I Evaluate the safety and efficacy of synthetic dehydroepiandrosterone GL701 in women with active systemic lupus erythematosus
I Evaluate the safety and efficacy of synthetic dehydroepiandrosterone GL701 in women with active systemic lupus erythematosus
Detailed Description:
PROTOCOL OUTLINE This is a randomized study Patients are stratified by participating institution
Patients are randomly assigned to daily oral dehydroepiandrosterone or placebo for 52 weeks Patients are evaluated every 13 weeks on study and return for a follow-up 6 weeks after completion of therapy
Concurrent therapy with estrogen replacement and stable doses of prednisone azathioprine methotrexate with folate supplementation hydroxychloroquine and nonsteroidal anti-inflammatory drugs is allowed Other investigational medications and immunosuppressants are prohibited
Patients are randomly assigned to daily oral dehydroepiandrosterone or placebo for 52 weeks Patients are evaluated every 13 weeks on study and return for a follow-up 6 weeks after completion of therapy
Concurrent therapy with estrogen replacement and stable doses of prednisone azathioprine methotrexate with folate supplementation hydroxychloroquine and nonsteroidal anti-inflammatory drugs is allowed Other investigational medications and immunosuppressants are prohibited
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NU-584 | None | None | None |