Ignite Creation Date:
2024-05-04 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004795
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase IIIII Randomized Double-Blind Placebo-Controlled Study of Dehydroepiandrosterone in Women With Mild to Moderate 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 prednisone-dependent systemic lupus erythematosus
II Describe the pharmacokinetics of GL701
II Describe the pharmacokinetics of GL701
Detailed Description:
PROTOCOL OUTLINE This is a randomized double-blind study Patients are stratified by participating institution
Patients are randomly assigned to 1 of 2 doses of oral dehydroepiandrosterone or placebo administered daily for a minimum of 7 months A prednisone taper is attempted each month in patients with stable or improving disease Therapy continues until a successful prednisone taper is achieved and sustained for at least 2 months or until a maximum of 9 months
Patients are followed for 1 year after entry
Patients are randomly assigned to 1 of 2 doses of oral dehydroepiandrosterone or placebo administered daily for a minimum of 7 months A prednisone taper is attempted each month in patients with stable or improving disease Therapy continues until a successful prednisone taper is achieved and sustained for at least 2 months or until a maximum of 9 months
Patients are followed for 1 year after entry
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-517 | None | None | None |