Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00174941
Status:
COMPLETED
Last Update Posted:
2011-01-27
First Post:
2005-09-12
Brief Title:
Long-Term Safety of Febuxostat in Subjects With Gout
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
Phase II Open-Label Study to Assess the Long-Term Safety of Oral TMX-67 in Subjects With Gout
Status:
COMPLETED
Status Verified Date:
2011-01
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:
FOCUS
Brief Summary:
The purpose of this study is to evaluate the long-term safety of febuxostat once daily QD in maintaining serum urate levels within clinically acceptable levels in subjects with gout
Detailed Description:
Uric acid is the end product of purine degradation in humans Hyperuricemia a urate concentration in serum exceeding the limit of urate solubility approximately 70 milligrams per deciliter mgdL is a common biochemical abnormality Aberrations in any of the multiple mechanisms involved in the production andor excretion of uric acid may increase serum urate concentrations with persistent hyperuricemia as a marker for extracellular fluid monosodium urate supersaturation As such hyperuricemia is a necessary but often not sufficient risk factor for monosodium urate crystal deposition in tissues and is the fundamental pathophysiological process underlying the clinical manifestations of gout which is a chronic disease characterized by urate crystal formation and deposition in joints and bones Gout may progress from episodic attacks of acute inflammatory arthritis to a disabling chronic disorder characterized by deforming arthropathy destructive deposits of urate crystals tophi in bones joints and other organs structural and functional renal impairment due to interstitial urate crystal deposition and urinary tract stones composed entirely or in part of uric acid crystals Management of gout requires chronic treatment aimed at lowering serum urate into a subsaturating range usually 60 mgdL in which crystal formation and deposition are prevented or reversed
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
Subjects who want to participate in this study will have successfully completed study TMX-00-004 NCT00174967
All participants will initially receive an 80 mg dose Dose titrations will occur in order to obtain and maintain clinically acceptable serum urate levels
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
Subjects who want to participate in this study will have successfully completed study TMX-00-004 NCT00174967
All participants will initially receive an 80 mg dose Dose titrations will occur in order to obtain and maintain clinically acceptable serum urate levels
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 |
|---|---|---|---|
| U1111-1114-2039 | REGISTRY | WHO | None |