Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00348296
Status:
COMPLETED
Last Update Posted:
2010-07-30
First Post:
2006-07-03
Brief Title:
Efficacy and Safety Study of GB-0998 for Treatment of Systemic Sclerosis
Sponsor:
Benesis Corporation
Organization:
Benesis Corporation
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Multi-center Study of GB-0998 for Treatment of Systemic Sclerosis
Status:
COMPLETED
Status Verified Date:
2010-07
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:
This randomized double-blind placebo-controlled multi-center study will carry out to assess the efficacy of GB-0998 in the treatment of the systemic sclerosis based on the changes in modified Rodnan total skin thickness score TSS as primary endopoint and in addition to assess the safety of GB-0998
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None