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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1114-1944 | Registry Identifier | WHO |
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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.
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 7.0 milligrams per deciliter (mg/dL), 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.1 As serum urate levels increase beyond greater than 7.0 mg/dL, the risks for gouty arthritis or for renal calculi increase.
Febuxostat is a 2-aryl-thiazole derivative chemically engineered as a novel xanthine oxidase/dehydrogenase 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tophi Participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measurement of Tophi to validate procedure | Other | Intra- and Inter-rater Reproducibility measurements of the area (in mm2) of each tophus nodule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Percent Difference in Area Between Visits | The rater measured length and width (mm) of the tophus at 2 visits separated by no more than 10 days. Area of the tophus was summarized using average percent difference, calculated as absolute difference of Visits 1 and 2 divided by the average of Visits 1 and 2 for the same tophus, pooled across raters. | Visit 1 (Day 1) and Visit 2 (Days 6-11) |
| Average Percent Difference in Area Between Raters | Each rater measured length and width (mm) of the tophus at 2 visits separated by no more than 10 days. Area of the tophus was summarized using the average percent difference, calculated as the absolute difference of Raters 1 and 2 divided by the average of Raters 1 and 2 for the same tophus, pooled across visits. | Visit 1 (Day 1 ) and Visit 2 (Day 6-11) |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with palpable tophi >10mm 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.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16331766 | Result | Schumacher HR Jr, Becker MA, Palo WA, Streit J, MacDonald PA, Joseph-Ridge N. Tophaceous gout: quantitative evaluation by direct physical measurement. J Rheumatol. 2005 Dec;32(12):2368-72. |
| Label | URL |
|---|---|
| Uloric Package Insert | View source |
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Subjects were enrolled at 2 study sites in the United States from 19 November 2002 to 09 January 2003.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tophi Participants | Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tophi Participants | Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Percent Difference in Area Between Visits | The rater measured length and width (mm) of the tophus at 2 visits separated by no more than 10 days. Area of the tophus was summarized using average percent difference, calculated as absolute difference of Visits 1 and 2 divided by the average of Visits 1 and 2 for the same tophus, pooled across raters. | Measurements of 52 tophi were obtained at 2 separate visits separated by no more than 10 days from the 13 subjects enrolled. Change in tophus size over 10 days was not expected. | Posted | Mean | Standard Deviation | mm² | Visit 1 (Day 1) and Visit 2 (Days 6-11) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tophi Participants | Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. VP, Clinical Science | Takeda Global Research and Development Center, Inc. | 800-778-2860 | clinicaltrialregistry@tpna.com |
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| ID | Term |
|---|---|
| D006073 | Gout |
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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None taken or retained
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Average Percent Difference in Area Between Raters | Each rater measured length and width (mm) of the tophus at 2 visits separated by no more than 10 days. Area of the tophus was summarized using the average percent difference, calculated as the absolute difference of Raters 1 and 2 divided by the average of Raters 1 and 2 for the same tophus, pooled across visits. | Measurements of 52 tophi were obtained at 2 separate visits separated by no more than 10 days from the 13 subjects enrolled. | Posted | Mean | Standard Deviation | mm² | Visit 1 (Day 1 ) and Visit 2 (Day 6-11) |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
| D012216 |
| Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |