Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00175019
Status:
COMPLETED
Last Update Posted:
2010-07-27
First Post:
2005-09-12
Brief Title:
Allopurinol Versus Febuxostat in Subjects Completing the Phase 3 Trials C02-009 or C02-010
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Phase 3 Open-Label Randomized Allopurinol-Controlled Study to Assess the Long-Term Safety of Oral Febuxostat in Subjects With Gout
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:
EXCEL
Brief Summary:
The purpose of this study is to determine the long-term safety of febuxostat once daily QD compared to allopurinol in reducing serum urate 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 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 insufficient 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 partially of uric acid crystals Management of gout requires chronic treatment aimed at lowering serum urate levels 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 the management of hyperuricemia in patients with gout
This study was originally designed and initiated having all subjects initially assigned to 80 mg febuxostat provided as an 80 mg tablet to be administered orally Subjects could be titrated to 120 mg provided as one 40 and 80 mg tablet between Months 2 and 6 if their serum uric acid rose 60 mgdL the dose could be down-titrated to 80 mg if the serum uric acid decreased to 30 mgdL
The protocol was amended to add a comparator arm and to have subjects randomized to 80 or 120 mg febuxostat or allopurinol 100 or 300 mg dependent on renal function The information below reflects the treatments following the implementation of the revised protocol
Febuxostat TMX-67 is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for the management of hyperuricemia in patients with gout
This study was originally designed and initiated having all subjects initially assigned to 80 mg febuxostat provided as an 80 mg tablet to be administered orally Subjects could be titrated to 120 mg provided as one 40 and 80 mg tablet between Months 2 and 6 if their serum uric acid rose 60 mgdL the dose could be down-titrated to 80 mg if the serum uric acid decreased to 30 mgdL
The protocol was amended to add a comparator arm and to have subjects randomized to 80 or 120 mg febuxostat or allopurinol 100 or 300 mg dependent on renal function The information below reflects the treatments following the implementation of the revised protocol
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 |
|---|---|---|---|
| U1111-1113-9814 | REGISTRY | WHO | None |