Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00175006
Status:
COMPLETED
Last Update Posted:
2010-07-27
First Post:
2005-09-12
Brief Title:
Validation Study of Physical Measurement of Tophi
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Study to Assess a Direct Physical Measurement Method for Evaluation of Tophus Nodules 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:
None
Brief Summary:
The purpose of this study is to determine the inter- and intra-rater reproducibility of direct physical measurement of tophus nodules in subjects with gout
Detailed Description:
Gout is a chronic urate crystal deposition disorder Left untreated gout 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 greater than 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 nephrolithiasis1 As serum urate levels increase beyond greater than 70 mgdL the risks for gouty arthritis or for renal calculi increase
Febuxostat is a 2-aryl-thiazole derivative chemically engineered as a novel xanthine oxidasedehydrogenase inhibitor Febuxostat is being developed as an orally administered agent for the management of hyperuricemia in patients with gout
Subjects with palpable tophi 10 millimeters mm in length and width and as round as possible will have the tophus measured on two separate visits by two different raters to assess the inter- and intra-rater reproducibility of direct physical measurement
Febuxostat is a 2-aryl-thiazole derivative chemically engineered as a novel xanthine oxidasedehydrogenase inhibitor Febuxostat is being developed as an orally administered agent for the management of hyperuricemia in patients with gout
Subjects with palpable tophi 10 millimeters mm in length and width and as round as possible will have the tophus measured on two separate visits by two different raters to assess the inter- and intra-rater reproducibility of direct physical measurement
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 |
|---|---|---|---|
| U1111-1114-1944 | REGISTRY | WHO | None |