Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00430248
Status:
COMPLETED
Last Update Posted:
2012-02-02
First Post:
2007-01-25
Brief Title:
Efficacy and Safety of Oral Febuxostat in Participants With Gout
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Phase 3 Randomized Multicenter Double-Blind Allopurinol-Controlled Study Assessing the Efficacy and Safety of Oral Febuxostat 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:
CONFIRMS
Brief Summary:
The purpose of this study is to compare the efficacy and safety of febuxostat once Daily QD to allopurinol in subjects with hyperuricemia and gout
Detailed Description:
Renal impairment is common in subjects with gout with the prevalence ranging from 50 to 70 This population represents an unmet medical need as uricosuric drugs are contraindicated in these patients and the only available treatment allopurinol may have to be dose reduced to avoid overt side effects
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
Treatment duration will be 6 months
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
Treatment duration will be 6 months
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 |
|---|---|---|---|
| U1111-1114-0226 | REGISTRY | WHO | None |