Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00174967
Status:
COMPLETED
Last Update Posted:
2011-07-29
First Post:
2005-09-09
Brief Title:
Dose-Response Safety and Efficacy of Febuxostat in Subjects With Gout
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
Phase II Dose-Response Safety and Efficacy Study of Oral TMX-67 in Subjects With Gout
Status:
COMPLETED
Status Verified Date:
2011-07
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:
The purpose of this study is to determine the efficacy of febuxostat once daily QD in reducing serum urate levels in subjects with gout
Detailed Description:
Gout is a chronic urate crystal deposition disorder which if left untreated may result in progressive disease characterized by joint and bone destruction from tophaceous deposits and renal impairment due to gouty nephropathy Hyperuricemia defined as a serum urate concentration of 70 milligrams per deciliter mgdL is the underlying metabolic aberration leading to urate crystal deposition in gout Gout has several clinical presentations including recurrent acute attacks of inflammatory arthritis deposition of monosodium urate monohydrate crystals in joints bones and even parenchymal organs tophaceous gout renal impairment and uric acid nephrolithiasis As serum urate levels increase beyond 70 mgdL the risks for gouty arthritis or for renal calculi increase
Currently allopurinol is the only xanthine oxidase inhibitor available Allopurinol is the agent of choice for reduction of serum urate levels in patients with uric acid overproduction unresponsive or intolerant to uricosuric agents impaired renal function uric acid urolithiasis or tophi
Febuxostat TMX-67 is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for management of hyperuricemia in patients with gout
Currently allopurinol is the only xanthine oxidase inhibitor available Allopurinol is the agent of choice for reduction of serum urate levels in patients with uric acid overproduction unresponsive or intolerant to uricosuric agents impaired renal function uric acid urolithiasis or tophi
Febuxostat TMX-67 is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for management of hyperuricemia in patients with gout
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 |
|---|---|---|---|
| U1111-1114-1992 | REGISTRY | WHO | None |