Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00102440
Status:
COMPLETED
Last Update Posted:
2012-02-02
First Post:
2005-01-29
Brief Title:
Febuxostat Versus Allopurinol Control Trial in Subjects With Gout
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Phase 3 Randomized Multicenter Study Comparing the Safety and Efficacy of Oral Febuxostat Versus Allopurinol in Subjects With Gout
Status:
COMPLETED
Status Verified Date:
2012-01
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:
FACT
Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of febuxostat once daily QD versus allopurinol in subjects with gout
Detailed Description:
This was a randomized controlled double-blind study of 52 weeks duration Subjects receiving prior urate-lowering therapy underwent a 2-week washout period prior to randomization Subjects were then randomized to one of three treatment groups febuxostat 80 milligram mg febuxostat 120 mg or allopurinol 300 mg Naproxen 250 mg twice daily or colchicine 06 mg once daily was provided for prophylaxis of acute gout flares during the washout period and the first 8 weeks of double-blind treatment
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1114-0184 | REGISTRY | WHO | None |