|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Study Type: | Interventional |
|---|---|
| Study Design: | Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment |
| Condition: |
Gout |
| Interventions: |
Drug: Febuxostat Drug: Allopurinol |
Baseline Characteristics
| Description | |
|---|---|
| Febuxostat 80 mg QD | Febuxostat 80 mg, orally, once daily for up to 52 weeks. |
| Febuxostat 120 mg QD | Febuxostat 120 mg, orally, once daily for up to 52 weeks. |
| Allopurinol 300 mg QD | Allopurinol 300 mg, orally, once daily for up to 52 weeks. |
| Febuxostat 80 mg QD | Febuxostat 120 mg QD | Allopurinol 300 mg QD | Total | |
|---|---|---|---|---|
|
Number of Participants [units: participants] |
256 | 251 | 253 | 760 |
|
Age, Customized [units: subjects] |
||||
| <45 years | 75 | 71 | 84 | 230 |
| 45 years to <65 years | 140 | 133 | 125 | 398 |
| ≥65 years | 41 | 47 | 44 | 132 |
|
Age [units: years] Mean ± Standard Deviation |
51.8 ± 11.69 | 52.0 ± 12.12 | 51.6 ± 12.63 | 51.8 ± 12.13 |
|
Gender [units: subjects] |
||||
| Female | 13 | 8 | 10 | 31 |
| Male | 243 | 243 | 243 | 729 |
|
Body Mass Index [units: subjects] |
||||
| <18.5 kilogram per meter² (kg/m²) | 0 | 0 | 0 | 0 |
| 18.5 kg/m² to <25 kg/m² | 15 | 12 | 7 | 34 |
| 25 kg/m² to <30 kg/m² | 75 | 87 | 89 | 251 |
| ≥30 kg/m² | 166 | 152 | 154 | 472 |
| missing | 0 | 0 | 3 | 3 |
|
Calculated Creatinine Clearance[1] [units: subjects] |
||||
| <50 milliliters per minute (mL/min) | 13 | 8 | 13 | 34 |
| 50 mL/min to <80 mL/min | 77 | 90 | 68 | 235 |
| 80 mL/min to <120 mL/min | 138 | 130 | 140 | 408 |
| ≥120 mL/min | 28 | 23 | 29 | 80 |
| missing | 0 | 0 | 3 | 3 |
|
Presence of Primary Palpable Tophus [units: subjects] |
||||
| Yes | 52 | 53 | 46 | 151 |
| No, but other tophi present | 1 | 2 | 3 | 6 |
| No and no other tophi present | 203 | 196 | 204 | 603 |
|
Race/Ethnicity [units: subjects] |
||||
| White | 193 | 199 | 195 | 587 |
| Black or African American | 24 | 20 | 18 | 62 |
| Hispanic | 22 | 17 | 19 | 58 |
| Asian | 10 | 9 | 6 | 25 |
| Other | 7 | 6 | 15 | 28 |
| [1] | Calculated creatinine clearance based on the Cockcroft-Gault equation using ideal body weight. |
|---|
Outcome Measures
| 1. Primary: | Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL) [ Last 3 Visits (up to 52 weeks) ] |
| 2. Secondary: | Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 28 Visit [ Week 28 ] |
| 3. Secondary: | Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 52 Visit [ Week 52 ] |
| 4. Secondary: | Percentage of Subjects With Serum Urate <6.0 mg/dL at Final Visit [ Final Visit (up to 52 weeks) ] |
| 5. Secondary: | Percent Change From Baseline in Serum Urate Levels at Week 28. [ Baseline and Week 28 ] |
| 6. Secondary: | Percent Change From Baseline in Serum Urate Levels at Week 52. [ Baseline and Week 52 ] |
| 7. Secondary: | Percent Change From Baseline in Serum Urate Levels at Final Visit [ Baseline and Final Visit (up to 52 weeks) ] |
| 8. Secondary: | Percent Change From Baseline in Tophus Size at Week 28, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening. [ Baseline and Week 28 ] |
| 9. Secondary: | Percent Change From Baseline in Tophus Size at Week 52, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening. [ Baseline and Week 52 ] |
| 10. Secondary: | Percent Change From Baseline in Tophus Size at Final Visit, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening. [ Baseline and Final Visit (up to 52 weeks) ] |
| 11. Secondary: | Change From Baseline in Total Number of Tophi at Week 28 in Subjects With Palpable Tophi at Screening. [ Baseline and Week 28 ] |
| 12. Secondary: | Change From Baseline in Total Number of Tophi at Week 52 in Subjects With Palpable Tophi at Screening. [ Baseline and Week 52 ] |
| 13. Secondary: | Change From Baseline in Total Number of Tophi at Final Visit in Subjects With Palpable Tophi at Screening. [ Baseline and Final Visit (up to 52 weeks) ] |
| 14. Secondary: | Percentage of Subjects Requiring Treatment for Gout Flares Between Weeks 8 and 52. [ Weeks 8 through 52 ] |
More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
| Responsible Party: | Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science ) |
| Study ID Numbers: | C02-010 |
| Study First Received: | January 29, 2005 |
| Results First Received: | March 12, 2009 |
| Last Updated: | August 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00102440 History of Changes |
| Health Authority: | United States: Food and Drug Administration |