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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1114-1992 | Registry Identifier | WHO |
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The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), in reducing serum urate levels in subjects with gout.
Gout is a chronic urate crystal deposition disorder, which if left untreated 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 of >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. As serum urate levels increase beyond >7.0 mg/dL, the risks for gouty arthritis or for renal calculi increase.
Currently allopurinol is the only xanthine oxidase inhibitor available. Allopurinol is the agent of choice for reduction of serum urate levels in patients with: uric acid overproduction; unresponsive or intolerant to uricosuric agents; impaired renal function; uric acid urolithiasis; or tophi.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo QD | Placebo Comparator |
| |
| Febuxostat 40 mg QD | Experimental |
| |
| Febuxostat 80 mg QD | Experimental |
| |
| Febuxostat 120 mg QD | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Febuxostat placebo-matching tablets, orally, once daily for up to 4 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 Milligram Per Deciliter (mg/dL) at the Day 28 Visit. | Serum urate values were obtained at the Day 28 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 28 visit was summarized. | Day 28. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 7 Visit. | Serum urate values were obtained at the Day 7 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 7 visit was summarized. | Day 7. |
| Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 14 Visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15751090 | Result | Becker MA, Schumacher HR Jr, Wortmann RL, MacDonald PA, Palo WA, Eustace D, Vernillet L, Joseph-Ridge N. Febuxostat, a novel nonpurine selective inhibitor of xanthine oxidase: a twenty-eight-day, multicenter, phase II, randomized, double-blind, placebo-controlled, dose-response clinical trial examining safety and efficacy in patients with gout. Arthritis Rheum. 2005 Mar;52(3):916-23. doi: 10.1002/art.20935. | |
| 16911575 |
| Label | URL |
|---|---|
| Uloric Package Insert | View source |
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Participants currently receiving urate-lowering therapy discontinued those urate-lowering therapies and initiated prophylactic medications before enrollemnt in once daily (QD) treatment groups. All other subjects also initiated prophylactic medications.
Subjects were enrolled at 24 investigative sites from 31 January 2001 to 9 July 2001
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| ID | Title | Description |
|---|---|---|
| FG000 | Febuxostat 40 mg QD | Febuxostat 40 mg, orally, once daily. |
| FG001 | Febuxostat 80 mg QD | Febuxostat 80 mg, orally, once daily. |
| FG002 | Febuxostat 120 mg QD | Febuxostat 120 mg, orally, once daily. |
| FG003 | Placebo QD | Placebo, orally, once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Febuxostat 40 mg QD | Febuxostat 40 mg, orally, once daily. |
| BG001 | Febuxostat 80 mg QD | Febuxostat 80 mg, orally, once daily. |
| 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 | Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 Milligram Per Deciliter (mg/dL) at the Day 28 Visit. | Serum urate values were obtained at the Day 28 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 28 visit was summarized. | Analysis performed on intent-to-treat (ITT) subjects, defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥8.0 mg/dL. The last observation carried forward (LOCF) method was used to impute missing data. The baseline value was carried forward if no postbaseline visits were available. | Posted | Number | percentage of subjects | Day 28. |
|
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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 | Febuxostat 40 mg QD | Febuxostat 40 mg, orally, once daily. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide Attempt | Psychiatric disorders | COSTART | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | General disorders | COSTART | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. VP, Clinical Science | Takeda Global Research & Development Center, Inc. | 800-778-2860 | clinicaltrialregistry@tpna.com |
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| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| ID | Term |
|---|---|
| D000069465 | Febuxostat |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Febuxostat |
| Drug |
Febuxostat 40 mg, tablets, orally, once daily for up to 4 weeks. |
|
|
| Febuxostat | Drug | Febuxostat 80 mg, tablets, orally, once daily for up to 4 weeks. |
|
|
| Febuxostat | Drug | Febuxostat 120 mg, tablets, orally, once daily for up to 4 weeks. |
|
|
Serum urate values were obtained at the Day 14 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 14 visit was summarized. |
| Day 14. |
| Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 21 Visit. | Serum urate values were obtained at the Day 21 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 21 visit was summarized. | Day 21. |
| Percent Change in Serum Urate Levels From Baseline to the Day 7 Visit. | Serum urate values were obtained at the Day 7 visit. The percent change in serum urate from baseline to the Day 7 visit was summarized. | Baseline and Day 7. |
| Percent Change in Serum Urate Levels From Baseline to the Day 14 Visit. | Serum urate values were obtained at the Day 14 visit. The percent change in serum urate from baseline to the Day 14 visit was summarized. | Baseline and Day 14. |
| Percent Change in Serum Urate Levels From Baseline to the Day 21 Visit | Serum urate values were obtained at the Day 21 visit. The percent change in serum urate from baseline to the Day 21 visit was summarized. | Baseline and Day 21. |
| Percent Change in Serum Urate Levels From Baseline to the Day 28 Visit. | Serum urate values were obtained at the Day 28 visit. The percent change in serum urate from baseline to the Day 28 visit was summarized. | Baseline and Day 28. |
| Maximum Percent Change in Serum Urate Level From Baseline During the Entire Treatment Period. | Serum urate values were obtained at the Day 7, 14, 21,and 28 visits. The maximum percent change in serum urate levels obtained at any visit was summarized. | Baseline and Any visit (Day 7, 14, 21,or 28) |
| Percent Change in 24-hour Urine Uric Acid Level From Baseline to Day 28. | 24-hour urine uric acid levels were obtained at the Day 28 visit. The percent change in 24-hour urine uric acid level from baseline to the Day 28 visit was summarized. | Baseline and Day 28. |
| Result |
| Colwell HH, Hunt BJ, Pasta DJ, Palo WA, Mathias SD, Joseph-Ridge N. Gout Assessment Questionnaire: Initial results of reliability, validity and responsiveness. Int J Clin Pract. 2006 Oct;60(10):1210-7. doi: 10.1111/j.1742-1241.2006.01104.x. Epub 2006 Aug 15. |
| 21572152 | Result | Goldfarb DS, MacDonald PA, Hunt B, Gunawardhana L. Febuxostat in gout: serum urate response in uric acid overproducers and underexcretors. J Rheumatol. 2011 Jul;38(7):1385-9. doi: 10.3899/jrheum.101156. Epub 2011 May 15. |
| Gout Flare |
|
| Other |
|
| BG002 | Febuxostat 120 mg QD | Febuxostat 120 mg, orally, once daily. |
| BG003 | Placebo QD | Placebo, orally, once daily |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Body Mass Index | Number | participants |
|
| Febuxostat 80 mg QD |
Febuxostat 80 mg, orally, once daily. |
| OG002 | Febuxostat 120 mg QD | Febuxostat 120 mg, orally, once daily. |
| OG003 | Placebo QD | Placebo, orally, once daily |
|
|
|
| Secondary | Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 7 Visit. | Serum urate values were obtained at the Day 7 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 7 visit was summarized. | The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available. | Posted | Number | percentage of subjects | Day 7. |
|
|
|
|
| Secondary | Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 14 Visit. | Serum urate values were obtained at the Day 14 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 14 visit was summarized. | The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available. | Posted | Number | percentage of subjects | Day 14. |
|
|
|
|
| Secondary | Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 21 Visit. | Serum urate values were obtained at the Day 21 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 21 visit was summarized. | The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available. | Posted | Number | percentage of subjects | Day 21. |
|
|
|
|
| Secondary | Percent Change in Serum Urate Levels From Baseline to the Day 7 Visit. | Serum urate values were obtained at the Day 7 visit. The percent change in serum urate from baseline to the Day 7 visit was summarized. | The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available. | Posted | Mean | Standard Deviation | percent change from baseline | Baseline and Day 7. |
|
|
|
|
| Secondary | Percent Change in Serum Urate Levels From Baseline to the Day 14 Visit. | Serum urate values were obtained at the Day 14 visit. The percent change in serum urate from baseline to the Day 14 visit was summarized. | The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available. | Posted | Mean | Standard Deviation | percent change from baseline | Baseline and Day 14. |
|
|
|
|
| Secondary | Percent Change in Serum Urate Levels From Baseline to the Day 21 Visit | Serum urate values were obtained at the Day 21 visit. The percent change in serum urate from baseline to the Day 21 visit was summarized. | The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The last observation carried forward (LOCF) method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available. | Posted | Mean | Standard Deviation | percent change from baseline | Baseline and Day 21. |
|
|
|
|
| Secondary | Percent Change in Serum Urate Levels From Baseline to the Day 28 Visit. | Serum urate values were obtained at the Day 28 visit. The percent change in serum urate from baseline to the Day 28 visit was summarized. | The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available. | Posted | Mean | Standard Deviation | percent change from baseline | Baseline and Day 28. |
|
|
|
|
| Secondary | Maximum Percent Change in Serum Urate Level From Baseline During the Entire Treatment Period. | Serum urate values were obtained at the Day 7, 14, 21,and 28 visits. The maximum percent change in serum urate levels obtained at any visit was summarized. | The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. | Posted | Mean | Standard Deviation | percent change from baseline | Baseline and Any visit (Day 7, 14, 21,or 28) |
|
|
|
|
| Secondary | Percent Change in 24-hour Urine Uric Acid Level From Baseline to Day 28. | 24-hour urine uric acid levels were obtained at the Day 28 visit. The percent change in 24-hour urine uric acid level from baseline to the Day 28 visit was summarized. | The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. Missing data was not imputed | Posted | Mean | Standard Deviation | percent change from baseline | Baseline and Day 28. |
|
|
|
|
| 0 |
| 37 |
| 18 |
| 37 |
| EG001 | Febuxostat 80 mg QD | Febuxostat 80 mg, orally, once daily. | 1 | 40 | 19 | 40 |
| EG002 | Febuxostat 120 mg QD | Febuxostat 120 mg, orally, once daily. | 2 | 38 | 16 | 38 |
| EG003 | Placebo QD | Placebo, orally, once daily | 0 | 38 | 17 | 38 |
| Delirium | Nervous system disorders | COSTART | Systematic Assessment |
|
| Guillian Barre Syndrome | Nervous system disorders | COSTART | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Back Pain | General disorders | COSTART | Systematic Assessment |
|
| Accidental Injury | Injury, poisoning and procedural complications | COSTART | Systematic Assessment |
|
| Back Pain | General disorders | COSTART | Systematic Assessment |
|
| Flu Syndrome | General disorders | COSTART | Systematic Assessment |
|
| Headache | Nervous system disorders | COSTART | Systematic Assessment |
|
| Infection | Infections and infestations | COSTART | Systematic Assessment |
|
| Pain | General disorders | COSTART | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Increased Appetite | Gastrointestinal disorders | COSTART | Systematic Assessment |
|
| Liver Function Tests Abnormal | Investigations | COSTART | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
|
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 |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| <0.001 |
Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure. |
| 95 |
| No |
| Superiority or Other |
| Fisher Exact | <0.001 | Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure. | 95 | No | Superiority or Other |
| <0.001 |
Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure. |
| 95 |
| No |
| Superiority or Other |
| Fisher Exact | <0.001 | Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure. | 95 | No | Superiority or Other |
| <0.001 |
Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure. |
| 95 |
| No |
| Superiority or Other |
| Fisher Exact | <0.001 | Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure. | 95 | No | Superiority or Other |
| <0.001 |
Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure. |
| 95 |
| No |
| Superiority or Other |
| t-test, 2 sided | <0.001 | Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure. | 95 | No | Superiority or Other |
| <0.001 |
Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure. |
| 95 |
| No |
| Superiority or Other |
| t-test, 2 sided | <0.001 | Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure. | 95 | No | Superiority or Other |
| <0.001 |
Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure. |
| 95 |
| No |
| Superiority or Other |
| t-test, 2 sided | <0.001 | Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure. | 95 | No | Superiority or Other |
| <0.001 |
Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure. |
| 95 |
| No |
| Superiority or Other |
| t-test, 2 sided | <0.001 | Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure. | 95 | No | Superiority or Other |
| <0.001 |
Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure. |
| 95 |
| No |
| Superiority or Other |
| t-test, 2 sided | <0.001 | Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure. | 95 | No | Superiority or Other |
| <0.001 |
Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure. |
| 95 |
| No |
| Superiority or Other |
| t-test, 2 sided | <0.001 | Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure. | 95 | No | Superiority or Other |